Oxymetazoline hydrochloride nasal spray

REXALL SINUS NASAL PUMP MIST

REXALL SINUS NASAL PUMP MIST- oxymetazoline hydrochloride 0.05% liquid

Dollar General

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

———-

DRug Facts

Active ingredients Purpose

Oxymetazoline Hydrochloride 0.05% Nesal Decongestant

Us es

temporarily relief nasal decongestion due to:

– common cold

– hay fever

– upper respiratory allergies

– shrinks swollen membranes

– temporarily restores freer breathing through the nose

Do not use this product if person has heart disease, high blood pressure, thyroid disease, diabetes, or

if adult has difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

When using this product

Do not exceed recommended dosage.

This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in

nasal discharge.

The use of this container by more than one person may spread infection

Stop use and ask doctor if

Symptoms persist

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of the children

Directions. Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in

each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.

Children under 6 years of age: consult a doctor

shake well before each use. Before using for the first time remove the protective cap from the tip and

prime mitered pump by depressing pump firmly several times. To remove the cap, squeeze cap at the

base on opposite sides on the two smooth impressions with fingers. While squeezing, twist cap

counterclockwise to remove. Remove clip and press down to use. Refer to directions on top of each

cap. To reapply cap, turn cap on pump clockwise until it locks. To spray, hold bottle with thumb at base

and nozzle between first and second flingers. Without tilting head, insert nozzle into nostril. Fully

depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use.

Inactive ingredients

Benzalkonium Chloride

Camphor

Disodium EDTA

Disodium Phosphate

Eucalyptol

Menthol

Polysorbate 20

Propylene Glycol

Sodium Phosphate

Water

REXALL SINUS NASAL PUMP MIST

oxymetazoline hydrochloride 0.05% liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:559 10 -778

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Dollar General

Ingredient Name

Basis of Strength

Stre ng th

O xymeta zo line Hydro chlo ride (UNII: K8 9 MJ0 S5VY) (OXYMETAZOLINE –

UNII:8 VLN5B44ZY)

O xyme ta z o line

Hydro c hlo ride

0 .0 5 g

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Benza lko nium Chlo ride (UNII: F5UM2KM3W7)

CAMPHO R ( SYNTHETIC) (UNII: 5TJD8 2A1ET)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

SO DIUM PHO SPHATE, DIBASIC, ANHYDRO US (UNII: 22ADO53M6 F)

EUCALYPTO L (UNII: RV6 J6 6 0 4TK)

Mentho l (UNII: L7T10 EIP3A)

Po lyso rba te 2 0 (UNII: 7T1F30 V5YH)

Pro pylene Glyco l (UNII: 6 DC9 Q16 7V3)

So dium Pho spha te (UNII: SE337SVY37)

Wa ter (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:559 10 -778 -0 1 30 mL in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct

12/21/20 15

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

12/21/20 15

Labeler –

Dollar General (068331990)

Registrant –

Product Quest Mfg (927768135)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Pro duct Quest Mfg

9 2776 8 135

manufacture(559 10 -778 ) , label(559 10 -778 )

Revised: 10/2017

Oxymetazoline nasal

Generic Name: oxymetazoline nasal (ox ee me TAZ oh leen NAY sal)
Brand Name: 12 Hour Nasal, Afrin, Afrin No Drip Sinus, Allerest 12 Hour Nasal Spray, Dristan 12-Hour, Duramist Plus, Duration, Mucinex Full Force, Mucinex Moisture Smart, Nasal Mist, Neo-Synephrine 12 Hour, Nostrilla, NRS Nasal, Sinarest Nasal, Sinex Long-Acting, Sudafed OM Sinus Cold, Zicam Extreme Congestion Relief, Zicam Sinus Relief, …show all 43 brand namesNTZ Long Acting Nasal, Genasal, Oxymeta-12, Twice-A-Day, Oxyfrin, Afrin Nasal Sinus, Four-Way Nasal Spray, 12 Hour Nasal Decongestant, Neo-Synephrine 12 Hour Extra Moisturizing, Afrin No Drip Severe Congestion, Mucinex Sinus-Max Full Force, Afrin Pump Mist, Afrin Extra Moisturizing, Afrin Severe Congestion, Afrin Severe Congestion NoDrip, Afrin NoDrip Extra Moisturizing, Afrin All Night NoDrip, Sudafed OM Sinus Congestion, Sinex 12 Hour Moisturizing, Sinex 12 Hour, Sinex 12 Hour Ultra Fine Mist, Mucinex Sinus-Max Moisture Smart, Sinex Moisturizing Ultra Fine Mist, Sinex Severe Ultra Fine Mist, Sinex Severe

Medically reviewed by Drugs.com on May 13, 2019 – Written by Cerner Multum

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

What is oxymetazoline nasal?

Oxymetazoline is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Oxymetazoline nasal (for the nose) is for temporary relief of nasal congestion (stuffy nose) caused by allergies or the common cold.

Oxymetazoline nasal may also be used for purposes not listed in this medication guide.

Important Information

Oxymetazoline nasal (for the nose) is used for temporary relief of nasal congestion caused by allergies or the common cold.

Stop using oxymetazoline nasal and call your doctor at once if you have ongoing or worsening symptoms, or if you have severe burning or stinging in your nose after using the nasal spray

Before taking this medicine

You should not use oxymetazoline nasal if you are allergic to it.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have other medical conditions, especially:

  • heart disease, high blood pressure, coronary artery disease;

  • diabetes;

  • a thyroid disorder; or

  • enlarged prostate or urination problems.

FDA pregnancy category C. It is not known whether oxymetazoline nasal will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether oxymetazoline nasal passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I use oxymetazoline nasal?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Using the medication too long or too often may worsen your symptoms or cause nasal congestion to clear up and come back.

Call your doctor if your symptoms do not improve after 3 days of treatment.

Do not share this medication with another person, even if they have the same symptoms you have. Sharing a nasal spray bottle can spread infection.

To use the nose drops (nasal solution):

  • Blow your nose gently. Tilt your head back as far as possible, or lie down and hang your head over the side of a bed. Hold the dropper over your nose and place the correct number of drops into your nose.

  • Sit up and bend your head slightly forward, then move it gently left and right. Stay seated with your head bent forward for a few minutes.

  • Avoid sneezing or blowing your nose for at least a few minutes after using the nose drops.

To use the nasal spray:

  • Blow your nose gently. Keep your head upright and insert the tip of bottle into one nostril. Press your other nostril closed with your finger. Breathe in quickly and gently spray the medicine into your nose. Then use the spray in your other nostril.

  • Do not blow your nose for at least a few minutes after using the nasal spray.

Do not use the nasal spray more than 2 times in 24 hours.

Wipe the tip of the spray bottle with a clean tissue but do not wash with water or soap.

Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Keep oxymetazoline nasal out of the reach of children. Certain nasal medications can cause serious medical problems in a young child who accidentally sucks on or swallows medicine from the nasal spray bottle.

What should I avoid while using oxymetazoline nasal?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Oxymetazoline nasal side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using oxymetazoline nasal and call your doctor at once if you have:

  • ongoing or worsening symptoms;

  • severe burning or stinging in your nose after using the nasal spray;

  • chest pain, fast or uneven heart rate; or

  • severe headache, buzzing in your ears, anxiety, confusion, or feeling short of breath.

Common side effects may include:

  • mild burning or stinging of the nose;

  • sneezing; or

  • runny nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Oxymetazoline nasal dosing information

Usual Adult Dose for Nasal Congestion:

2 or 3 sprays in each nostril not more often than every 10 to 12 hours

-Do not exceed 2 doses in any 24-hour period.
Uses: Temporary relief of nasal congestion due to common cold, hay fever, and
upper respiratory allergies

Usual Pediatric Dose for Nasal Congestion:

6 years or older:
2 or 3 sprays in each nostril not more often than every 10 to 12 hours

-Do not exceed 2 doses in any 24-hour period.
-Children ages 6 to under 12 years of age should use this drug with adult supervision.
Uses: Temporary relief of nasal congestion due to common cold, hay fever,
upper respiratory allergies

What other drugs will affect oxymetazoline nasal?

Ask a doctor or pharmacist if it is safe for you to use oxymetazoline nasal if you are also using any of the following drugs:

  • an antidepressant–amitriptyline, clomipramine, desipramine, doxepin, imipramine, nortriptyline;

  • ergot medicine–ergotamine, dihydroergotamine, ergonovine, methylergonovine; or

  • an MAO inhibitor–isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, tranylcypromine.

This list is not complete and other drugs may interact with oxymetazoline nasal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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

Copyright 1996-2018 Cerner Multum, Inc. Version: 4.03.

Medical Disclaimer

More about oxymetazoline nasal

  • Side Effects
  • During Pregnancy or Breastfeeding
  • Dosage Information
  • Drug Interactions
  • Pricing & Coupons
  • 166 Reviews
  • Drug class: nasal antihistamines and decongestants
  • FDA Alerts (5)

Consumer resources

  • Oxymetazoline (Nasal)
  • Oxymetazoline Nasal (Advanced Reading)

Other brands: Afrin, Afrin Original, Vicks Sinex Severe Nasal Spray, Vicks Sinex 12-Hour Decongestant Nasal Spray, … +25 more

Professional resources

  • Oxymetazoline (Nasal) (Wolters Kluwer)

Related treatment guides

  • Nasal Congestion

Oxymetazoline (oxymetazoline hydrochloride)

Oxymetazoline is a nasal decongestant.

Pronunciation: OX-ee-MET-azz-oh-leen

What are oxymetazoline’s uses?

Oxymetazoline gives short-term relief for nasal congestion due to colds, hay fever, upper respiratory tract allergies, sinus infection or a runny nose. It’s available over the counter as a nose spray.

What dosage should you take?

The dose depends on your age and reason for taking it.

However, a typical guideline for the nasal spray or drops is:

  • Adults and children over six: Use two or three drops or sprays of 0.05% solution in each nostril every ten to twelve hours. Don’t use more than twice in 24 hours.

However, first check the correct dosage with your Clicks pharmacist, particularly when it comes to children up to six years old.

What special precautions should you take?

  • Don’t use for longer than three days. Frequent or long-term use of oxymetazoline may cause nasal congestion to recur or worsen.
  • Don’t share it with anyone as this can spread infection.
  • May affect blood sugar levels. Speak to your doctor about any risks.
  • If you plan on becoming pregnant, discuss the risks of using oxymetazoline during pregnancy with your doctor.
  • It isn’t known if oxymetazoline is excreted in breast milk during breastfeeding. Discuss any risks with your doctor.
  • Its use should be avoided in children younger than six, however discuss this with your doctor or Clicks pharmacist.

Oxymetazoline should be used with caution if you suffer from the following conditions, so first discuss its use with your doctor or Clicks pharmacist:

  • Heart problems
  • High blood pressure (hypertension)
  • Prostate problems such as an enlarged prostate
  • Urination problems
  • Diabetes

What drug interactions could you experience?

As a rule, always inform your doctor or Clicks pharmacist what prescription and non-prescription medications, vitamins, nutritional supplements and herbal products you are taking or planning to take to ensure you don’t suffer the effects of adverse drug interactions.

What are oxymetazoline’s side effects?

Side effects could include:

  • Increase in nasal discharge
  • Sneezing
  • Stinging
  • Burning

More severe side effects include:

  • Severe allergic reactions (rash, hives, difficulty breathing, tightness in the chest and swelling of the mouth).

This is not a complete list of side effects. It’s essential that you call your doctor should you notice any severe or odd side effects.

What are the overdose symptoms?

Call a doctor or the ambulance immediately if you notice the following symptoms:

  • Extreme tiredness
  • Sweating
  • Dizziness
  • A slow heartbeat

The accuracy of this information was checked and approved by Clicks’ pharmacist Waheed Abdurahman in August 2015

Can I take a decongestant pill and nasal spray at the same time?

When I use an over-the-counter decongestant nasal spray, like Afrin, can I also take decongestant pills? What should I watch out for?

There is probably no need to take them at the same time, say our pharmacist consultants. You don’t need to—and, if you do take both, you might get an overload of decongestant. But when suffering from a cold, it may be a good idea to use a spray for the first few days, and then switch to an oral decongestant, if it’s still needed. (If congestion is caused by allergies, your best, first bet is an over-the-counter antihistamine.)

Nasal sprays are topical decongestants. The active ingredient works within minutes to shrink swollen blood vessels in your nasal passages, helping you breathe more easily. Sprays containing oxymetazoline, such as Afrin, Dristan, or Vicks Sinex, can relieve congestion for up to 12 hours, while sprays containing phenylephrine, like Neo-Synephrine, last up to four hours.

At recommended doses, they’re usually not absorbed into the bloodstream the way that oral medications are, but occasionally they can—say, if you took more than the recommended dose, or you tilted your head back while spraying your nostrils allowing some of the spray to enter your throat. (This is less apt to happen if you keep your head upright.)

Because of that possibility, those who have enlarged prostate, glaucoma, heart disease, high blood pressure, or thyroid disease should check with their doctor or pharmacist before using nasal sprays at all because all decongestants, including sprays, can worsen these conditions. If you experience insomnia, dizziness, weakness, tremor or an irregular heartbeat contact your doctor right away.

Also, nasal sprays are usually only recommended for a maximum of three days’ use. When used for a longer period of time, you could face rebound congestion—short-term, severe congestion as the medication effect wears off. “When you stop using the spray, the vessels in your nose that have been held in check begin to swell, making you feel congested,” says pharmacist Beverly Schaefer, co-owner of Katterman’s Pharmacy in Seattle. “It takes one to three days to get back to normal.”

To avoid rebound congestion, try taking the oxymetazoline nasal drops or sprays for the first three days, then make a switch to pseudoephedrine pills (Sudafed and generic). Be aware too that exceeding the recommended dosage of pseudoephedrine can cause nervousness, dizziness or sleeplessness. To get pseudoephedrine, you’ll have to ask the pharmacist since it’s no longer carried on pharmacy shelves–only behind the counter. However, you don’t need a prescription.

For nasal congestion relief, don’t rule out nondrug treatments. For example, studies show that a saltwater rinse for the nose can also help. And, believe it or not, chicken soup can help you feel better. A least one study has shown it prevented a build-up of white blood cells, which trigger the inflammatory response that makes you feel so poorly when you have a cold.

If you’re a frequent nasal-spray user, ask your doctor what might be the cause of your congestion, rather than depending on prolonged use of the drug and risking the rebound effect. There could be an underlying problem, such as a sinus infection or allergies. Your doctor may prescribe an antihistamine or steroid nasal spray that’s more appropriate for a chronic condition.

Have a medication question or pharmacy concern? Our pharmacist consultants can help. E-mail us at: [email protected] and include “PHARMACY QUESTION” in the Subject line.

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