Brom pse dm syrup

The common cold will usually run its course within 7 to 14 days. There are many natural remedies and over the counter products that are compatible with breastfeeding.

Image credit: Jerry Bunker on flickr

Natural Remedies

  • Rest. Drink lots of water and take hot baths. Run a humidifier.
  • Take in extra vitamin C from foods, juices or in supplement form.
  • Echinacea is generally recognized to be safe for nursing moms.
  • Garlic eaten raw, cooked, or taken as a supplement can help. Raw is always best, though it’s hardest to get down.
  • Homeopathic remedies, are considered safe for nursing moms.
  • OMT is a very gentle form of osteopathic manipulation, which can enhance the immune system, and help keep the fluids draining from the head and neck so bacteria and viruses are less likely to be able to grow. This can help to reduce or even prevent chronic ear and respiratory infections. OMT has been shown to have a dramatic effect on fluid in the ears, and works well on any type of upper respiratory infection.

Head congestion

  • Use a saline nasal spray
  • Steam treatments:
    • Boil a pot of water, remove from the stove and (optional) add a few drops of essential oils (for example: eucalyptus, sage and balsam). Drape a bath towel over your head and breathe deeply for 5 minutes. Do this 2 or 3x a day until symptoms subside.
    • Put two inches of apple cider vinegar in a pan and heat until it begins to steam. Inhale the vapor. If the vapor is too strong, add a little water. Repeat as needed.
  • Essential Oils: Place a drop or two of either eucalyptus or peppermint essential oil on a cotton ball or handkerchief and hold near the nose while breathing deeply.
    • A couple of cautions: Do not use the oil in the nose – it can cause swelling. Do not use peppermint oil or menthol (one of the main components in peppermint oil) or camphor on or near the breast where baby might ingest it, and do not apply directly on the skin of a baby or young child. There have been cases where the direct application of menthol or camphor products (for example, Vicks VapoRub™) to baby’s skin resulted in severe breathing difficulties or liver problems (see info on colds and congestion in baby).
  • Cayenne pepper: Sprinkle it on your food, or put a quarter teaspoon in a glass of water and drink.
  • Drink fenugreek tea to relieve head and chest congestion and cough.
  • What To Do When You Have Sinus Pain by Allison Ishman

Chest congestion

  • Anise steam treatment: Boil a pot of water, remove from the stove and add about 3 teaspoons of dried anise. Drape a bath towel over your head and breathe deeply for 5 minutes. Do this 3x a day to help keep the chest clear.
  • Drink fenugreek tea to relieve head and chest congestion and cough.

Sore, itchy throat and/or cough

  • Drink strong black tea (use 2 tea bags per cup).
  • Drink hot lemonade with honey. Or make a mixture of one part lemon juice and two parts honey. Sip throughout the day.
  • Drink fenugreek tea to relieve head and chest congestion and cough.
  • Use Zinc gluconate lozenges, but avoid taking large amounts of zinc for more than seven days, because it can interfere with other minerals in the body.
  • Salt water gargle:
    Mix a 1 tablespoon of salt in eight ounces of warm water. Gargle the whole mixture (don’t swallow) several times a day.
  • Apple-cider vinegar and water gargle.
    Mix 1-6 teaspoons (1/3 – 2 tablespoons) vinegar in a glass of water; you can mix it as strong as you can stand it. Gargle one mouthful (swallow afterward or spit it out). Repeat twice. Do this every hour, or as needed.
  • Slippery elm bark can help with sore throat and cough. It comes in herbal cough drops and throat lozenges (check the other ingredients!), or you can make a tea. For tea, use 1 to 3 teaspoons of powdered bark per cup, boil and simmer 15 minutes. Up to 3 cups per day.
  • Chamomile tea gargle (you can also drink the tea)

Medications generally regarded as safe

  • Treat only the symptoms you have: avoid a combination medicine when a single one will do the job.
  • Short-acting forms of drugs (6 hours or less) are generally better than the long-acting varieties (but see the info below on the nonsedating antihistamines).
  • Use nasal spray instead of oral medications when possible (see below).
  • Take any medication right AFTER you nurse and only as needed.

The current edition of Medications and Mothers’ Milk by Thomas Hale, PhD has information on many cold medications (including specific guidance on combination products) in the Appendix. Many of the active ingredients in cold and allergy medications are listed below.

Cough & sore throat meds

  • Sore throat sprays or lozenges are generally considered safe, as are cough drops. Avoid eating excessive amounts of cough drops containing menthol. Large amounts of menthol can reduce milk supply.
  • Many forms of Robitussin, Delsym and Benylin are considered compatible with breastfeeding. Always check the active ingredients, as there are many versions.

Pain meds

Both Advil/Motrin (Ibuprofen) and Tylenol (Acetaminophen) are considered compatible with breastfeeding.

Aleve (Naproxen) is also AAP-approved for nursing mothers, but (per Hale) should be used with caution due to its long half-life and its effect on baby’s cardiovascular system, kidneys and GI tract; short-term, infrequent or occasional use is not necessarily incompatible with breastfeeding.

Aspirin use is discouraged in children due to the risk of Reye’s syndrome. Although the risk is probably low, it is also discouraged in nursing mothers because of the potential risk of Reye’s syndrome and bleeding.

Eye drops

Eye drops designed for cold/allergy symptom relief are considered compatible with breastfeeding.

Nasal sprays or gels

Nasal sprays are generally considered compatible with breastfeeding.

Decongestant nasal sprays are generally for short-term use (3-7 days) only; consult your health care provider and the package instructions for specific information.

Of the preparations available for treatment of allergic symptoms, corticosteroid nasal sprays (e.g., Flonase, Nasacort, etc.) and cromolyn sodium nasal spray (a mast cell stabilizer, e.g., Nasalcrom) are considered to be, by far, some of the most effective and safest to use in breastfeeding moms. The plasma levels of these drugs are extremely low, and thus milk levels would be even lower.

A homeopathic nasal gel, made by Zicam and containing ionic zinc gluconate, was recalled by the US FDA in 2009 because it has been associated with long lasting or permanent loss of smell (anosmia) . Zicam contains small amounts of zinc (Zincum Gluconicum) – 266 micrograms per squirt; in one study (Mossad 2003) the daily dosage used was 2.1 mg per day. Zinc is considered compatible with breastfeeding, particularly in small amounts (excessive amounts are not a good idea, for mom’s sake rather than baby’s). The amount of systemic absorption of nasal sprays/gels is minimal compared to oral ingestion.

Decongestants

Both pseudoephedrine and phenylephrine are generally considered to be safe for the breastfed baby, but pseudoephedrine may reduce milk supply.

Pseudoephedrine & milk supply: Thomas Hale Ph. D., a renowned breastfeeding pharmacologist (Breastfeeding Pharmacology), notes that “breastfeeding mothers with poor or marginal milk production should be exceedingly cautious in using pseudoephedrine” and that “it is apparent that mothers in late-stage lactation may be more sensitive to pseudoephedrine and have greater loss in milk production” (Medications and Mother’s Milk, 2012 edition).

Dr. Hale is referring to this study: Aljazaf K, et. al. Pseudoephedrine: effects on milk production in women and estimation of infant exposure via breastmilk. Br J Clin Pharmacol. 2003 Jul;56(1):18-24.

If you do take pseudoephedrine and notice a drop in milk supply (many moms do not, but research shows that it can decrease milk supply by as much as 24%), simply stop the medication and take measures to increase milk supply – the problem should resolve fairly quickly.

Be very cautious about taking pseudoephedrine on a regular basis, as it has the potential to permanently decrease your milk supply. Regular use of pseudoephedrine (120 mg/day) has occasionally been used to decrease milk production in moms with overproduction, where the usual methods to regulate milk production were not working.

Antihistamines

Mom’s use of sedating antihistamines (including Benadryl and Chlor-Trimeton products) are generally regarded to be compatible with breastfeeding, but always double-check the active ingredients as they can vary greatly. Monitor your infant for possible drowsiness if you use this type of antihistamine. The non-sedating antihistamines (below) are generally preferred and are less likely to sedate baby.

The ingredients of Claritin, Claritin-D, Clarinex, Allegra, Allegra-D, and Zyrtec are generally regarded to be compatible with breastfeeding (again – always double-check the active ingredients). Loratadine (Claritin) has been studied and the amount of loratadine that passes into breastmilk is extremely low. Claritin-D and Allegra-D have the decongestant pseudoephedrine added (see above about possible effect on milk supply). Dr. Hale has said that he prefers the non-sedating antihistamines (even though they are long-acting) over the sedating allergy medications.

Milk supply: A common concern is that the sedating antihistamines might lower milk supply but, per Dr. Thomas Hale, there is no current research supporting this belief – only some anecdotal reports. If you feel that your supply has decreased, it could simply be a byproduct of decreased nursing frequency or dehydration due to your illness.

If you feel that a medication is the cause of a sudden drop in milk supply, then stop taking (or decrease your use of) the medication – if the med is indeed the cause, then supply should increase again soon after you stop taking it. When using an antihistamine, it can be helpful to step up your fluid intake quite a bit. As with any medication, take it only as needed, and discontinue use as soon as you can.

Links for additional information

General

  • Should breastfeeding continue when mom is sick? @
  • Cough and cold remedies and breastfeeding by Wendy Jones PhD, MRPharmS
  • Over-The-Counter Treatments for Cough and Cold from the InfantRisk Center
  • Maternal Health by Paula Yount
  • Natural treatments for nursing moms @
  • Herbs and Breastfeeding @
  • Natural Treatments for Colds by Dee Negron
  • Best Herbs for the Common Cold by Linda White, M.D. (remember that not all herbs are appropriate for nursing mothers)

Medications

Cold Medicine and Breastfeeding: Is it Safe?

What we do know is this: Medications get into breast milk, but probably in smaller doses than what the mom is taking. Basically, says Dr. Ross, the baby will probably get only 10 percent of whatever dose mom takes when breastfeeding — so there might be only one-tenth of the effect of the medication on the baby.

Cold Medications and Breastfeeding: Dos and Dont’s

Many over-the-counter cold medicine products are considered safe during pregnancy, when baby is directly impacted. So it’s generally considered safe for breastfeeding moms to take those medications with, of course, the same precautions.

“Go with the ingredient that you need, not something that has lots of ingredients, and not something that has sustained release,” says Ross. A sustained release product means your baby will get the medication over a longer period of time. Choose medications with only one ingredient for the symptom that’s plaguing you most and avoid combination cough and common cold medicines that have ingredients for cough, sneezing, congestion, headache, and more.

Simple diphenhydramine (Benadryl) and guaifenesin (Robitussin) are fine, says Ross. And you can take ibuprofen (Motrin, Advil) and aspirin while breastfeeding, which were a no-no for pregnant women. Those drugs are “not shown to do damage to most newborn babies,” Ross says.

Of course, if your baby’s behavior changes — more fussiness, for example — consider that it could have something to do with your medication.

Ross says it’s also fine to use something like Vicks VapoRub or a saline mist. Just be careful that the Vicks doesn’t get on your breasts. It won’t affect your baby unless it gets on the breasts and the baby eats it.

Herbal medications and remedies are not recommended for breastfeeding women, as the FDA does not regulate them and their safety can’t be confirmed.

Cold Medications: Risks and Side Effects in Breastfeeding

Any potential side effects for mom and baby are about the same — and pretty minor. A side effect that affects you will affect your baby, like drowsiness or the jitters.

While pseudoephedrine (Sudafed) is approved for use during pregnancy and hasn’t been found to harm newborn babies who are breastfeeding, Ross notes that it can make children jittery. Diphenhydramine, on the other hand, might make your little one a little bit sleepy, but not cause any problems or damage — and who’s going to complain about a newborn sleeping just a little longer? Some pediatricians actually given Benadryl to newborns to manage certain conditions, so, Ross says, a little bit in the breast milk is probably fine.

Cold Medicine and Breastfeeding: Check With Your Doctor

Never take any medications, including common cold medications, without checking with your obstetrician or your child’s pediatrician. And even if side effects are minimal, it’s still best to be conservative when taking cough and cold medicine while breastfeeding.

Ross recommends that moms take as few doses as possible and space them out as much as possible while still managing the symptoms — don’t casually take them every couple of hours to ward off symptoms. Take them when you need them without overdoing it, for your baby’s sake.

Dextromethorphan use while Breastfeeding

Drugs containing Dextromethorphan: Nuedexta, Mucinex DM, Bromfed DM, Promethazine with DM, Delsym, Promethazine DM, Vicks NyQuil Cold & Flu Nighttime Relief, Vicks Dayquil Cold & Flu Relief, Vicks NyQuil Severe Cold & Flu, Tussin DM, Show all 975 “Robitussin Cough + Chest Congestion DM, Cough & Cold Relief, Vicks Nyquil D Cold and Flu Nighttime Relief, Tylenol Cold & Flu Severe, Vicks Nyquil Cough, Delsym 12 Hour Cough Relief, Cough Syrup DM, Robitussin Cough & Cold D, Resperal-DM, Mucinex Fast-Max Severe Congestion & Cough, Robafen DM, Vicks DayQuil Severe Cold & Flu, Tusnel, Delsym Cough+ Chest Congestion DM, Robitussin Allergy & Cough, Promethazine with Dextromethorphan, Coricidin HBP Cough & Cold, Rynex DM, Robitussin Multi-Symptom Cold CF, Mucinex DM Maximum Strength, Dry Cough, Decorel Forte Plus, Capron DMT, Severe Cold Multi-Symptom, Delsym Cough+ Cold Day Time, Tussi-Pres B, Dimetapp Children’s Cold & Cough, Tussin CF, Capron DM, Ed A-Hist DM, Dexall, Polytussin DM, VanaTab DM, Bisolvon Dry, Robitussin Nighttime Cough DM, Pecgen DMX, Iophen DM, Coricidin HBP Chest Congestion & Cough, Mucinex Children’s Cough, Vicks Dayquil Cough, Vicks NyQuil Cold & Flu Nighttime Relief (Alcohol Free), Tylenol Cold, Comtrex Cold and Flu Maximum Strength Tablet, Theraflu Flu & Cough, Mucosa DM, Benylin Expectorant, Mucus Relief Cough, Triphenicol, Tylenol Cold Max Day, Cold Multi-Symptom (Daytime), Alka-Seltzer Plus Maximum Strength Day & Night Cold & Flu Liquid Gels (Day Formula), Comtrex Cold & Cough, Tussin DM Max, Guaifenesin DM, Tussex, Daytime Cold and Flu Relief, Creo-Terpin, Cofex-DM, Tussin Cough, M-End DM, Guaiasorb Cough Medicine, Vicks DayQuil Mucus Control DM, Cold Multi-Symptom (Nighttime), Alahist DM, Mucus Relief Complete, Robitussin Severe Multi-Symptom Cough Cold + Flu, Mucinex Sinus-Max Pressure, Pain & Cough, CounterAct Day, Alka-Seltzer Plus-D Multi-Symptom Sinus & Cold Liquid Gels, Balminil DM + Decongestant + Expectorant, Protuss DM, Robitussin Multi-Symptom Cold CF Maximum Strength, Mintex DM, Tylenol Cold Multi-Symptom Nighttime, Codral Cold and Flu + Cough Day and Night, Mucinex Children’s Congestion & Cough, Deconex DMX, Giltuss, Zotex, G-Tron Ped, Dexcon-PE, Desgen DM, Brotapp-DM, Dimacol, Effective Strength Cough Syrup, ChlorDex GP, Rondec-DM, Cardec DM, Robitussin Cough & Allergy, Corfen-DM, Cough Formula M Multi-Symptom, Cough-X Cough Relief, Cepacol Extra Strength Sore Throat & Cough, Sudafed Cough Syrup, Mucinex Fast-Max Severe Cold, Sudafed PE Cold & Cough, Theraflu (pseudoephedrine) Daytime Severe Cold, Tylenol Children’s Cold + Cough + Runny Nose, PediaCare Children’s Long-Acting Cough, Night Time Multi Symptom Cold/Flu Relief, Codimal DM, Resperal, Night Time Cold & Flu, Sucrets Cough, Lloydspharmacy Dry Adult Cough, DexAlone, Tylenol Cold Multi-Symptom Nighttime Liquid, Vicks Formula 44, Pertussin ES, M-End DMX, Dextromethorphan HBr Adult Formula, Buckleys Mixture, Histex-DM, Coricidin HBP Maximum Strength Flu, Covonia Bronchial Balsam, Phenergan with Dextromethorphan, Robitussin Cough + Chest Congestion Sugar-Free DM, Robafen DM Max, G-Zyncof, G-Tron, Cheracol-D, Tussi-Organidin DM-S NR, Balminil DM + Expectorant Sugar Free, Guaifen DM NR, Guiadrine DX, Biocotron, Atuss-12 DX, Robitussin Cough Long-Acting, G Bid DM, Vicks Nature Fusion Cough & Chest Congestion, Triaminic Thin Strips Long Acting Cough, Robafen DM Clear, Benadryl for the Family Dry Forte, Siltussin DM DAS Cough Formula, Mindal DM, Robitussin Children’ s Cough & Chest Congestion DM, Z-Cof LA, Extuss LA, ExeFen-DM, Contac Cough, Neocitran Thin Strips Cough, Theraflu Thin Strips Cough, Siltussin DM, Simuc-DM, Tussi-Organidin DM NR, Phlemex, DuraDEX, Mucus Relief DM, Relacon LAX, Aquatab DM, Z-Cof LAX, Cheracol D Cough, Robitussin Cough + Chest Congestion DM Maximum Strength, DuraDEX Forte, Zotex DMX, Guaibid DM, Siltussin-DM DAS-NA Maximum Strength, Safetussin DM, Phanatuss, Touro DM, Respa-DM, Mucobid DM, Fenesin DM, Humibid DM Pediatric, Iofen-DM NF, Strepsils Cough, Ambi 1000/55, Novahistine DM, Iobid DM, Calmylin, Naldecon Senior DX, Guiatussin-DM, Halotussin DM, Guiatuss DM, Double-Tussin DM, Halotussin DM Sugar Free, Rhinosyn-DMX, Tuss-DM, Q-Bid DM, Fenex-DM, Zyncof, Brontuss, Tussin DM Clear, Congesta DM, TabTussin DM, Tusnel Diabetic, Siltussin-DM DAS-NA, Mintab DM, Duratuss DM 12, Refenesen Chest Congestion Relief DM, Tussi-Organidin-DM, Guiadrine DM, Chest Congestion Relief DM, Guaifenex DM, Coricidin HBP Multi-Symptom Cold (Day), Triaminic Cough & Congestion, Dex-Tuss DM, Fenesin DM IR, Vicks DayQuil Cough & Congestion, Gani-Tuss-DM NR, Muco-Fen DM, Bidex-A, Tussi-Bid, Ru-Tuss 800 DM, Buckley’s Mixture Cough Suppressant, Alka-Seltzer Plus Cold & Cough Formula Liquid, PediaCare Multi-Symptom Cold Plus Acetaminophen, Tylenol Children’s Cold + Flu, Dimetapp Children’s Multi-Symptom Cold & Flu (old formulation), Hold, Scot-Tussin Diabetes, Duract Max Strength Cough, Vicks Nature Fusion Cough, Tussin Cough Gels (Long Acting), Buckley’s DM, Tylenol Cold Head Congestion Nighttime, Creomulsion, Creomulsion Children, Triaminic Long Acting Cough, Pedia Relief, Delsym Children’s 12-Hour Cough Relief, Strepsils Cough Relief, Mastussin DM, Recofen D, Recofen Plus, Ri-Tussin DM, PediaCare Flu Plus Acetaminophen, Comtrex Cold & Cough Day Night, T-Tussin DM, Tussin Pediatric, ElixSure Cough, Robitussin 12-Hour Cough Relief, Triaminic Thin Strips Cough, 12 Hour Cough Relief, Robitussin CoughGels Long-Acting, Hold DM, Pertussin CS Childrens, Robitussin Children’s Cough Long-Acting, St. Joseph Cough Suppressant, Robafen Pediatric Cough & Cold, Theraflu Nighttime Severe Cold & Cough Caplets, Dytan-DM, Duratuss AC 12, D-Tann DM, XL-3 Xtra Cold and Cough, Comtrex Nighttime Cold & Cough, Nighttime Cough, Safetussin PM, Robitussin Nighttime Cough DM Maximum Strength, Lortuss DM, Tylenol Cold Head Congestion Day and Night, Robichem DM, Tusscidin DM, Sudal DM, Tussinol for Dry Coughs, S-Pack DM, HT Tuss DM, Monafed DM, Hydro-Tuss DM, Drituss DM, Guaifen DM, Broncotron, Dristan DM, Bisolvon Dry Junior, Jack & Jill Thin Strips Cough, Allfen DM, Maxi-Tuss DM, Robafen Cough Liquidgels, Rompe Pecho DM, Su-Tuss DM, Biospec DMX, Muco-Fen 800 DM, Delsym Children’s Cough+ Chest Congestion DM, Guai-Dex, Guaifenesin DM SR, Scot-Tussin DM Cough Chasers, PediaCare Cough & Congestion, Iophen DM NR, Bidex-DMI, Nalspan Senior DX, Humibid CS, GG-DM SR, Humigen DM, Tussidin DM, Altarussin DM, Guiat Clear DM, Cough Formula-DM, Kita La Tos, Q-Tussin DM, Bidex-DM, Diabetic Tuss DM, Guiatuss Clear, Vicks Formula 44 Custom Care Chesty Cough, Scot-Tussin Senior, Mucinex Fast-Max DM Max, Naldecon DX Liquigel, Safetussin 30 DM, Nucosef DM, Dexi-Tuss, Amibid DM, Alka-Seltzer Plus Mucus & Congestion, Duratuss DM, Kolephrin GG/DM, Triaminic Flu, Cough & Fever, Duraganidin, Tusnel Pediatric, Profen II DM Liquid, ExeClear-DM, S-Pak DM, Ru-Tuss DM, Aldex GS DM, Relacon-DM, Coldmist DM, Altarussin CF, Z-Cof DM(obs), Ambifed-G DM, Touro CC-LD, Profen II DM, Relacon-DM NR, Despec Drops, Despec DM, Pseudo Cough, Relasin DM, Z-Cof DM, Ambi 40 /400 /20, Liquicough DM, Maxifed DMX, Z-Cof 12DM, Trikof-D, ExeFen-DMX, Profen Forte DM, Pseudo Max DMX, Dorcol Childrens Cough, Ambi 60/580/30, Ambifed DM, Tenar DM, Novahistine DM Expectorant with Decongestant, Z-COF 12, Donatussin DM Syrup, Anatuss DM, Ambenyl-D, Novahistine DMX, Ru-Tuss Expectorant, Rhinosyn-X, Syn-Rx DM, Touro CC, Guaifenex DM RX, Suda-Tussin DM, Pseudogest-DM, Tusnel Ped-C, Tusnel-DM Pediatric Drops, Medent DM, Daytime Liquicap, Multi Symptom Cough and Cold, Tussin Cough and Cold, Med-RX DM, Tussafed-LA, Pseudo DM GG, SudaTex-DM, Calmylin 4, PediaCare Cough & Runny Nose Plus Acetaminophen, Pryil DM, MyHist-DM, Tannate V DM, Ru-Hist Plus, Deconsal DM, Poly Hist DM, Tricodene Pediatric, Guiadex DM, Prolex DM, Vicks Formula 44 Custom Care Cough & Cold PM, Mapap Cough & Sinus Formula, Dexatrex D, Codituss DM, Buckley’s DM Decongestant, Drixoral Cough & Congestion Liquid Caps, Vicks 44D, Decongestant Cold Formula, Tussin Pediatric Cold and Cough, Balminil DM + Decongestant, Benylin DM-D, Pedia Relief Infant, Viravan-PDM, Pediatex TDM, Triaminic Multi-Symptom Fever, Reme Hist DM, Triplex DM, Desgen DM (with pseudoephedrine), Safetussin CD, P-Tuss DM, Delsym Cough+ Soothing Action, Robitussin Medi-Soothers Cough DM, Hot Lemon Cough and Colds Relief DM, Theraflu Cold & Cough, PediaCare Daytime Multi-Symptom Cold, Sudafed PE Children’s Cold & Cough, Albatussin Pediatric, Albatussin Pediatric Drops, Little Colds Decongestant/Cough, Children’s Triacting Daytime, Triaminic Thin Strips Day Time Cold & Cough, Viratan-DM, Triaminic Day Time Cold & Cough, PediaCare Children’s Multi-Symptom Cold, Theraflu Thin Strips Daytime Cold and Cough, Vicks Formula 44 Custom Care Congestion, Dimetapp Toddler’s Drops Decongestant Plus Cough, Codal-DM Syrup, Viravan-DM, V-Tan DM, Zotex-12, Deconsal DM Tannate, Aldex DM, Capmist DM, Ambi 80/780/40, Genatuss DM, Dynatuss EX, Tussi-Pres, Tussi-Pres Pediatric, Giltuss Pediatrics, Pres Gen, Tussafed-EX, GDP-EX, TriTuss, TriTuss-ER, Tussafed-EX Drops, Certuss-D (old formulation), Dacex-PE, G-Supress DX, Anextuss, Zotex LAX, Dacex-DM, Dexcon-DM, Duraphen II DM, Duraphen Forte, Maxiphen DM, G-Phen DM, Despec DM Syrup, Phlemex Forte, Phlemex-PE, Tusicof, Supress-DX, Guaphen II DM, Benylin DM, Glycotuss-DM, Mytussin DM, Tolu-Sed DM, Vicks Pediatric Formula 44e Cough & Chest Congestion Relief, Guiacough DM, Lotussin DM, Anti-Tuss DM, Aquabid DM, GG/DM, Tylenol Cold and Flu Severe Day & Night, Coricidin HBP Day & Night Multi-Symptom Cold, Robitussin Children’s Cough & Cold CF, Broncotron-D, Broncotron Ped, Rompe Pecho CF, Tusso-DMR, Pres Gen Pediatric, Duraphen DM, Sinutuss DM, Nortuss-DE, G-Tusicof, Zotex Pediatric, Tussidex, Relhist DMX, Guaphen Forte, Endacon, Benylin DM-D-E, Flu Relief BP, Naldelate DX Pediatric, Nalphen DX Childrens, Nalphen DX Pediatric, Ipsatol Cough Formula, Naldecon-DX Childrens, Uni Tussin CF, Pediacon DX, Phenadex, Tri-Dec, Humibid DM, Coricidin HBP Multi-Symptom Cold (Night), Z-Cof 8DM, Naldelate DX Childrens, Entex Pac, Entre-Cough, Poly-Vent DM, Medent-DMI, Robitussin CF, Mardrops-DX, Maxifed DM, PanMist DM, Sudafed Cough, TL-Dex DM, Ambi 600/1000/30, Naldecon-DX Pediatric, Guiatussin-CF, Z-Dex, Mucinex Children’s Multi-Symptom Cold, Robafen CF, DuraMAX, Tusso-XR, Execof ER, Tusso-DM, Ambi 40/1000/60, Maxiphen-G DM, Z-tuss DM, Deconex DM, PDM GG, ExeTuss-DM, Despec NR Drops, Guiatuss CF, Endacon DM, Giltuss TR, Q-Tussin CF, Desgen, Tusslin, Mucinex Fast-Max Day Time Severe Congestion & Cough, Mucinex Children’s Day Time Multi-Symptom Cold, Duravent DM, Zotex-EX, Nivanex DMX, Naldecon-DX Adult, Delsym 12 Hour Cough Relief for Children & Adults, Abatuss DMX, Balminil DM, Histacol DM Pediatric Syrup, AccuHist PDX Syrup, Uni-Hist PDX Syrup, Allanhist PDX Syrup, EndaCof-PD, Bromhist-PDX, Acutuss DM Pediatric, Uni-Hist DM Pediatric Syrup, AccuHist DM Pediatric Syrup, Bromhist-DM, Pediahist DM Syrup, Niva-Hist DM, Chloraseptic Total Sore Throat+Cough Lozenges, Alahist DM (old formulation), BroveX PB DM, BPM DM PHEN, Duravent DPB, Alacol DM, BP Allergy DM, Presgen B, Y-COF DMX, TL-Hist DM, Tusdec-DM, Bromtuss DM, Cepastat Sore Throat & Cough, Spec-T Sore Throat/Cough Suppressant, Dimaphen DM, Contact Cold and Sore Throat, Sudafed PE Pressure+Pain+Cough, Flu & Severe Cold & Cough Daytime Powder, Theraflu ExpressMax Daytime Severe Cold & Cough, Comtrex Non Drowsy Liquigel, Theraflu Flu Cold & Cough, Alka-Seltzer Plus Flu/Body, Vicks Dayquil Daytime Cold/Flu (old formulation), Comtrex Non-Drowsy, Contac Severe Cold and Flu Non Drowsy, Day Time Multi Symptom, Non-Drowsy Super Strength Contac Complete, Day Relief Cold and Flu, Cepacol Sore Throat + Cough Relief, Tylenol Cold Non-Drowsy Gelcaps, Daytime Non-Drowsy, Daytime Cold, Quelidrine, Alka-Seltzer Plus Flu Formula (old formulation), Alka-Seltzer Plus Cold & Cough Formula Effervescent Tablets, Alka-Seltzer Plus Day & Night Cold Formula (Night Cold), Alka-Seltzer Plus Night Cold Formula Effervescent Tablets, Alka-Seltzer Plus Day & Night Cold Formula (Day Cold), Cough-X, Cepacol Dual Relief Sore Throat + Cough Spray, Dur-Tann DM, Cold & Cough Childrens, Theraflu Warming Relief Daytime Severe Cold & Cough, Anaplex DMX, Contac Severe Cold and Flu Maximum Stength, Comtrex Maximum Strength Cold Relief, Dimetapp DM, EndaCof PD Drops, AccuHist DM Pediatric Drops, PediaHist DM, BroveX PSE DM Tablets, BroveX PSE DM, PBM Allergy, BroveX PSB DM, BromTann/DM Tann/PSE Tann, DM Cold and Cough, Bromdex D, Neo DM Syrup, Dallergy DM, Dimetane DX, Myphetane DX, Bromanate DX Cough, Bromatane DX, Myphetane DX Cough, Bromophed-DX, Liquiphed DM, Brometane DX, Durahistine DM, Poly Histine DM, BroveX PEB DM, AP-Hist DM, BPM PE DM, LoHist PEB DM, Dimetapp Children’s Multi-Symptom Cold Relief Dye-Free, Balacall DM, Brotapp PE-DM, Lohist-DM, Glenmax PEB DM, 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Clear Cough PM Multi-Symptom, Allpanto-S, All-Nite Cold, Tylenol Severe Cold & Flu Night Time, Multi-Symptom Nighttime, NyCair, All-Nite Multi-Symptom Cold/Flu Relief, Contac Cold and Flu Maximum Strength, Childrens Tylenol Cold Plus Cough, Genacol Maximum Strength, Comtrex Cold and Flu Maximum Strength Liquid, Comtrex Day and Night, Mucinex Fast-Max Day & Night, Vicks NyQuil HBP Cold & Flu, Mucinex Children’s Multi-Symptom Cold & Fever, Respa C&C, PediaCare Cough & Sore Throat Plus Acetaminophen, Triaminic Cough & Sore Throat, Drixoral Cough/Sore Throat, Tylenol Cough and Sore Throat Daytime, Triaminic Softchews Cough & Sore Throat, Children’s Triacting, Tylenol Cold & Cough Daytime, Topcare Cough and Sore Throat, Vicks DayQuil HBP Cold & Flu, Diabetic Tussin Night Time Cold & Flu, Diabetic Tussin Night Time Formula, Respa C&C IR, Tylenol Cough & Sore Throat Nightime, Contac Day and Night Cold and Flu, Theracaps Multi-Symptom Cough & Cold Reliever, Robitussin Peak Cold Nighttime Cold + Flu, Contac Cold + Flu (Night) Cooling Relief Liquid, Delsym Night Time Cough & Cold, Robitussin Cold + Flu (Nighttime), Coricidin HBP Nighttime Multi-Symptom Cold, Vicks Nature Fusion Cold & Flu Nighttime Relief, Tylenol Cold & Cough Nighttime, Multi Symptom NiteTime, Alka-Seltzer Plus Severe Cold+Cough Night Liquid, Mucinex Children’s Cold, Cough & Sore Throat, Mucinex Fast-Max Day Time Severe Cold, Theraflu Multi-Symptom Severe Cold with Lipton Flavors, BC Cough & Cold, Maxiflu DM, Tusnel-A, Theraflu Flu, Cold and Cough Powder, Robitussin Peak Cold Daytime Cold + Flu, Daytime Cold & Flu, Contac Complete Cough, Cold & Flu Extra Strength, Tylenol Plus Children’s Cold & Cough, Neocitran Non Drowsy Extra Strength Cold and Flu, Robitussin Cold + Flu (Daytime), Mapap Cold Formula, Little Colds Multi-Symptom, Flutabs, Vicks Nature Fusion Cold & Flu Multi-Symptom Relief, Theraflu Daytime Severe Cold & Cough, Comtrex Cold and Cough Maximum Strength, Day Relief PE, Vicks Dayquil Cold & Flu Symptom Relief Plus Vitamin C, Day Time Multi-Symptom Cold/Flu Relief, Multi Symptom Cold (Day Formula), Alka-Seltzer Plus Severe Sinus Congestion & Cough Liquid Gels, Alka-Seltzer Plus Maximum Strength Day Cold & Flu Liquid Gels, Alka-Seltzer Plus Severe Sinus Congestion & Cough (Day Formula), Alka-Seltzer Plus Multi-Symptom Cold & Flu Day Liquid Gels, Duraflu, Theraflu Max-D Severe Cold & Flu, Tylenol Cold Multi-Symptom Severe, Cold Head Congestion, Non-Pseudo Cold Relief, Tylenol Cold + Mucus Severe, Mucinex Fast-Max Cold, Flu & Sore Throat Liquid Gels, Tylenol Cold Head Congestion Severe (old formulation), Mucinex Fast-Max Cold, Flu & Sore Throat, Mucinex Fast-Max Severe Congestion & Cold, Alka-Seltzer Plus Severe Cough, Mucus & Congestion Liquid Gels, Alka-Seltzer Plus Severe Sinus, Cold & Cough Liquid Gels, Phenflu DM, Alka-Seltzer Plus Severe Cold, Mucus & Congestion, Alka-Seltzer Plus Day Severe Cold+Flu Hot Drink Mix, Cold Multi-Symptom Severe, Balminil Cough and Flu Sugar Free, ConRx Cold, Adult Cold, Flu & Sore Throat, Mucus Relief Plus, Cold & Cough PE Multi-Symptom, Suphedrine PE Cold & Cough, Sudafed PE Pressure+Pain+Cold, Tylenol Cough & Severe Congestion Daytime, Anatuss, Robitussin Cold Cough and Flu, Tylenol Cold Severe Congestion Daytime, Phlemgesic, Bromadine-DM, Bromphenex DM, Vicks Formula 44 Custom Care Dry Cough Suppressant, Tricodene Forte, De-Chlor DM, De-Chlor DR, Coldtuss-DR, Tri-Vent DPC, Atuss DR, Uni-Tuss DM, Mintuss DR, Trital DM, P Chlor DM, Dex PC, Tricodene NN, Norel DM, Cheracol Plus, Therahist, Kophane, Threamine DM, Rhinosyn-DM, Vicks 44M Pediatric, Creomulsion Cough/Cold/Allergy, Creomulsion Pediatric, Kidcare Cough and Cold, Children’s Nyquil, Rescon-DM, NeoTuss Plus, Father John’s Medicine Plus, C-Phed DM, Zotex-12D, Re DCP, Sonahist-DM, RE DCP Drops, Nohist-DMX, Bronkids, Donatussin DM Drops, Nasohist-DM, DM-PE-Chlor, CP Dec-DM Drops, PD-Cof Drops, PD-Cof, Quartuss DM, Atuss DM, Statuss DM, Gencontuss, Giltuss Allergy Plus, NoHist-PDX, Relahist-DM, Albatussin SR, Cerose DM, Maxiphen ADT, Tussar DM, Liquituss R-DM, Centergy DM, Tanafed-DM, Atuss-12 DM, Zoden DM Drops, Deltuss DMX, ProHist, P-Hist, Tannate DMP-DEX, C-Phed DPD Tann, DuraTan Forte, Bromatan Plus, Dur-Tann Forte, TanDur DM, SuTan-DM, Tannate PD-DM, Tylenol Children’s Cold + Cough + Sore Throat, Donatussin DM Suspension, TanaCof DM, Tanafed DMX, Alka-Seltzer Plus Severe Sinus & Cold Hot Drink Mix, Alka-Seltzer Plus Flu Formula, Alka-Seltzer Plus Severe Cold & Flu Formula Effervescent Tablets, Alka-Seltzer Plus Maximum Strength Cold & Cough Liquid Gels, Multi Symptom Cold Relief, Multi Symptom Cold (Night Formula), Babee Cof, Silphen DM, Pertussin DM, Coryza-DM, Dimetapp Children’s Nighttime Flu, Dicel DM, Duotan DM, Atuss DS, Entre-S, Maxichlor PSE DM, Kidkare Cough/Cold, Neutrahist PDX Drops, AccuHist PDX Drops, CPM-PSE DM Drops, Esocor P, Mesehist DM, Triaminic-D Multi-Symptom Cold, Allres DS, T-Tanna DM, Poly Tan DM, Pedia Relief Cough-Cold, Deka, Theraflu Warming Relief Nighttime Multi-Symptom Cold Caplets, Alahist CF, G-P-Tuss DXP, Y-Cof DM, Supress A, Panatuss DXP, Tussall, Tussall-ER, Supress A Pediatric, Phenabid DM, Virdec DM, Andehist DM NR Syrup, Cydec-DM Drops, Andehist DM NR, Carbodex DM Drops, Cordron-DM, Dynatuss, Tussafed, Biodec DM, Rondamine DM, Maldec-DM, Cydec-DM Syrup, Dura-Ron DM, Carbaxef-DM, DMax Pediatric, Carbofed DM Drops, Decahist-DM, Pediatex-DM, Cordron-DM NR, Pseudo Carb DM, PSE Carbinoxamine DM, PSE Carb DM Drops, Carboxine DM, Carboxine 12 DM, Carb PSE 12 DM, PSE Allergy DM, Trituss-A, DMax Syrup, Pediatex 12 DM, Uni-Hist PDX Drops, Bromtapp-DM, Bromaxefed DM RF Syrup, PSE Brom DM, Bromaline DM, Carbofed DM Syrup, Uni-Hist DM Pediatric Drops, Bromplex DM, Bromhist-DM Drops, Pediahist DM Drops, Q-Tapp DM, Bromph DM, Allanhist PDX Drops, DMax Pediatric Drops, Histacol BD Drops, Brom Tann, ProHist DM, P-Hist DM Drops, Carbodex DM Syrup, Sildec DM, DMax, TriTuss-A Drops, Dacex-A, XiraHistDM, X-Hist DM, Cordron-12 DM, Comtrex Cold and Flu Maximum Strength, Trigofen DM Drops, C-Phen DM, HistadecDM, CP Dec DM, Neo DM Drops, Nasohist-DM Pediatric, Cardec DM Drops, Balamine DM, Reme Tussin DM, NoHist DM, Tussplex DM, Norel CS, C-Phen DM Drops, Dec-Chlorphen DM, Sildec-PE DM Drops, Sildec-PE DM, DCP Drops, EndaCof Drops, PE-Hist DM, Maxichlor PEH DM, ED DM, Poly-Tussin DM, Ricotuss, Tri-Dex PE, Z-Dex 12 D, Dec-Chlorphen DM Drops, Rondex-DM Drops, Vicks Children’s NyQuil Cold & Cough, Robitussin Children’s Nighttime Cough Long-Acting DM, QC Cough/Cold, Primatuss 4, Tricodene Sugar Free, Triaminic Softchews Cough & Runny Nose, Dimetapp Children’s Long Acting Cough Plus Cold, Robitussin Children’s Cough & Cold Long-Acting, Robitussin Cough & Cold Long-Acting, Carepanto, Triaminic Night Time Cough & Runny Nose, Scot-Tussin DM, St. Joseph HBP Cough & Cold, SymPak DM, Rondex-DM, Broncopectol, Qual-Tussin, Quartuss, Genelan NF, Zotex-DM, Neotuss D, Extendryl DM, Triaminic Multi-Symptom Fever & Cold, Donatussin DM, Ceron-DM Drops, Ceron-DM, Panatuss Pediatric DXP

Medically reviewed by Drugs.com. Last updated on Apr 27, 2019.

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Dextromethorphan Levels and Effects while Breastfeeding

Summary of Use during Lactation

Neither the excretion of dextromethorphan in milk nor its effect on breastfed infants have been studied. It is unlikely that with usual maternal doses amounts in breastmilk would harm the nursing infant, especially in infants over 2 months of age. It is best to avoid the use of products with a high alcohol content while nursing.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Dextromethorphan Identification

Substance Name

Dextromethorphan

CAS Registry Number

Drug Class

Breast Feeding

Lactation

Antitussive Agents

Administrative Information

LactMed Record Number

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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  • Dextromethorphan
  • Dextromethorphan Capsules
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  • Dextromethorphan Hydrobromide (AHFS Monograph)
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  • Cough

Generic Name: brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
Dosage Form: syrup

Medically reviewed by Drugs.com. Last updated on Jan 1, 2019.

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Bromfed DM Description

Bromfed® DM Cough Syrup is a clear, light pink syrup with a butterscotch flavor.

Each 5 mL (1 teaspoonful) contains:

Brompheniramine Maleate, USP . . . . . . . . 2 mg

Pseudoephedrine Hydrochloride, USP . . . . . 30 mg

Dextromethorphan Hydrobromide, USP . . . 10 mg

Alcohol 0.95% v/v

In a palatable, aromatic vehicle.

Inactive Ingredients: artificial butterscotch flavor, citric acid anhydrous, dehydrated alcohol, FD&C Red No. 40, glycerin, liquid sugar, methylparaben, propylene glycol, purified water and sodium benzoate. It may contain 10% citric acid solution or 10% sodium citrate solution for pH adjustment. The pH range is between 3.0 and 6.0.

C16H19BrN2•C4H4O4 M.W. 435.31

Brompheniramine Maleate, USP(±)-2- p-Bromo-α-2-(dimethylamino)ethylbenzylpyridine maleate (1:1)

C10H15NO•HCl M.W. 201.69

Pseudoephedrine Hydrochloride, USP (+)-Pseudoephedrine hydrochloride

C18H25NO•HBr•H2O M.W. 370.32

Dextromethorphan Hydrobromide, USP 3-Methoxy-17-methyl-9α, 13α, 14α -morphinan hydrobromide monohydrate

Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration.

Bromfed DM – Clinical Pharmacology

Brompheniramine maleate is a histamine antagonist, specifically an H1-receptor-blocking agent belonging to the alkylamine class of antihistamines. Antihistamines appear to compete with histamine for receptor sites on effector cells. Brompheniramine also has anticholinergic (drying) and sedative effects. Among the antihistaminic effects, it antagonizes the allergic response (vasodilation, increased vascular permeability, increased mucus secretion) of nasal tissue. Brompheniramine is well absorbed from the gastrointestinal tract, with peak plasma concentration after single, oral dose of 4 mg reached in 5 hours; urinary excretion is the major route of elimination, mostly as products of biodegradation; the liver is assumed to be the main site of metabolic transformation.

Pseudoephedrine acts on sympathetic nerve endings and also on smooth muscle, making it useful as a nasal decongestant. The nasal decongestant effect is mediated by the action of pseudoephedrine on α-sympathetic receptors, producing vasoconstriction of the dilated nasal arterioles. Following oral administration, effects are noted within 30 minutes with peak activity occurring at approximately one hour.

Dextromethorphan acts centrally to elevate the threshold for coughing. It has no analgesic or addictive properties. The onset of antitussive action occurs in 15 to 30 minutes after administration and is of long duration.

Indications and Usage for Bromfed DM

For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

Contraindications

Hypersensitivity to any of the ingredients. Do not use in the newborn, in premature infants, in nursing mothers, or in patients with severe hypertension or severe coronary artery disease. Do not use dextromethorphan in patients receiving monoamine oxidase (MAOI) inhibitors (see PRECAUTIONS – Drug Interactions).

Antihistamines should not be used to treat lower respiratory tract conditions including asthma.

Warnings

Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death.

Antihistamines may diminish mental alertness. In the young child, they may produce excitation.

Precautions

General

Because of its antihistamine component, Bromfed® DM Cough Syrup should be used with caution in patients with a history of bronchial asthma, narrow angle glaucoma, gastrointestinal obstruction, or urinary bladder neck obstruction. Because of its sympathomimetic component, Bromfed® DM Cough Syrup should be used with caution in patients with diabetes, hypertension, heart disease, or thyroid disease.

Information for Patients

Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating dangerous machinery.

Drug Interactions

Monoamine oxidase (MAO) inhibitors

Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of MAO inhibitors and products containing dextromethorphan. In addition, MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines and may enhance the effect of pseudoephedrine. Concomitant administration of Bromfed® DM Cough Syrup and MAO inhibitors should be avoided (see CONTRAINDICATIONS).

Central nervous system (CNS) depressants

Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.).

Antihypertensive drugs

Sympathomimetic may reduce the effects of antihypertensive drugs.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies of Bromfed® DM Cough Syrup to assess the carcinogenic and mutagenic potential or the effect on fertility have not been performed.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Bromfed® DM Cough Syrup. It is also not known whether Bromfed® DM Cough Syrup can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed.

Reproduction studies of brompheniramine maleate (a component of Bromfed® DM Cough Syrup) in rats and mice at doses up to 16 times the maximum human doses have revealed no evidence of impaired fertility or harm to the fetus.

Nursing Mothers

Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Bromfed® DM Cough Syrup is contraindicated in nursing mothers.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 6 months have not been established (see DOSAGE AND ADMINISTRATION).

Geriatric Use

Clinical studies of Bromfed® DM Cough Syrup did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients. The elderly are also more likely to experience adverse reactions to sympathomimetics.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Adverse Reactions

The most frequent adverse reactions to Bromfed® DM Cough Syrup are: sedation; dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include:

Dermatologic: Urticaria, drug rash, photosensitivity, pruritus.

Cardiovascular System: Hypotension, hypertension, cardiac arrhythmias, palpitation.

CNS: Disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsions, headache, euphoria, and dysphoria.

G.U. System: Urinary frequency, difficult urination.

G.I. System: Epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation.

Respiratory System: Tightness of chest and wheezing, shortness of breath.

Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.

Overdosage

Signs and Symptoms

Central nervous system effects from overdosage of brompheniramine may vary from depression to stimulation, especially in children. Anticholinergic effects may be noted. Toxic doses of pseudoephedrine may result in CNS stimulation, tachycardia, hypertension, and cardiac arrhythmias; signs of CNS depression may occasionally be seen. Dextromethorphan in toxic doses will cause drowsiness, ataxia, nystagmus, opisthotonos, and convulsive seizures.

Toxic Doses

Data suggest that individuals may respond in an unexpected manner to apparently small amounts of a particular drug. A 2½-year-old child survived the ingestion of 21 mg/kg of dextromethorphan exhibiting only ataxia, drowsiness, and fever, but seizures have been reported in 2 children following the ingestion of 13–17 mg/kg. Another 2½-year-old child survived a dose of 300–900 mg of brompheniramine. The toxic dose of pseudoephedrine should be less than that of ephedrine, which is estimated to be 50 mg/kg.

Treatment

Induce emesis if patient is alert and is seen prior to 6 hours following ingestion. Precautions against aspiration must be taken, especially in infants and small children. Gastric lavage may be carried out, although in some instances tracheostomy may be necessary prior to lavage. Naloxone hydrochloride 0.005 mg/kg intravenously may be of value in reversing the CNS depression that may occur from an overdose of dextromethorphan. CNS stimulants may counter CNS depression. Should CNS hyperactivity or convulsive seizures occur, intravenous short-acting barbiturates may be indicated. Hypertensive responses and/or tachycardia should be treated appropriately. Oxygen, intravenous fluids, and other supportive measures should be employed as indicated.

Bromfed DM Dosage and Administration

Adults and pediatric patients 12 years of age and over: 10 mL (2 teaspoonfuls) every 4 hours. Children 6 to under 12 years of age: 5 mL (1 teaspoonful) every 4 hours. Children 2 to under 6 years of age: 2.5 mL (½ teaspoonful) every 4 hours. Infants 6 months to under 2 years of age: Dosage to be established by a physician.

Do not exceed 6 doses during a 24-hour period.

How is Bromfed DM Supplied

Bromfed® DM Cough Syrup is a clear, light pink-colored, butterscotch-flavored syrup containing in each 5 mL (1 teaspoonful) brompheniramine maleate 2 mg, pseudoephedrine hydrochloride 30 mg and dextromethorphan hydrobromide 10 mg, available in the following sizes:

4 fl oz (118 mL) NDC 60432-837-04

1 Pint (473 mL) NDC 60432-837-16

RECOMMENDED STORAGE

Store at 20 ° to 25 °C (68 ° to 77 °F) .

KEEP TIGHTLY CLOSED

Dispense in a tight, light-resistant container as defined in the USP.

Rx Only

Product No.: 8837

BROMFED® is a registered trademark of Wockhardt.

Manufactured For:

Wockhardt USA, LLC

Parsippany, NJ 07054

Manufactured By:

Morton Grove Pharmaceuticals, Inc.

Morton Grove, IL 60053

A50-8837-16

REV. 08-15

PRINCIPAL DISPLAY PANEL Bottle Label

NDC 60432-837-04

FDA-Approved

Bromfed® DM

Cough Syrup

Each 5 mL (teaspoonful) contains:

Brompheniramine Maleate, USP 2 mg

Pseudoephedrine Hydrochloride, USP 30 mg

Dextromethorphan Hydrobromide, USP 10 mg

Alcohol 0.95% v/v

Rx Only

WOCKHARDT

NET: 4 fl oz (118 mL)

DO NOT USE IF INNER FOIL SEAL PRINTED “SEALED

FOR YOUR PROTECTION” IS BROKEN OR MISSING.

Bromfed DM
brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide syrup
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:60432-837
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE 2 mg in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
PROPYLENE GLYCOL
SODIUM BENZOATE
ANHYDROUS CITRIC ACID
ALCOHOL
METHYLPARABEN
FD&C RED NO. 40
SUCROSE
TRISODIUM CITRATE DIHYDRATE
Product Characteristics
Color PINK (Light Pink) Score
Shape Size
Flavor BUTTERSCOTCH Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:60432-837-04 118 mL in 1 BOTTLE, PLASTIC
2 NDC:60432-837-16 473 mL in 1 BOTTLE, PLASTIC
3 NDC:60432-837-15 15 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088811 06/15/2010

Labeler – Morton Grove Pharmaceuticals, Inc. (801897505)

Registrant – Morton Grove Pharmaceuticals, Inc. (801897505)

Morton Grove Pharmaceuticals, Inc.

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  • Bromfed DM
  • Brompheniramine, Pseudoephedrine, Dextromethorpan Syrup (FDA)

Other brands: Carbofed DM Syrup, Bromdex D, EndaCof PD Drops, Myphetane DX, Sildec DM

  • Cough and Nasal Congestion

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