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Drug Facts
Children Afrin Extra Moisturizing Stuffy Nose Pump Mist Spray, Metered
FDA Label NDC 11523-0091
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Children Afrin Extra Moisturizing Stuffy Nose Pump Mist (NDC 11523-0091). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Oxymetazoline hydrochloride 0.025%
Purpose
Nasal decongestant
Uses
- temporarily relieves nasal congestion due to:
- common cold
- hay fever
- upper respiratory allergies
- temporarily relieves sinus congestion and pressure
- shrinks swollen nasal membranes so you can breathe more freely
Warnings
Ask a doctor before use if you or a child has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- do not use more than directed
- do not use for more than 3 days. Use only as directed.
- Frequent or prolonged use may cause nasal congestion to recur or worsen.
- temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
- use of this container by more than one person may spread infection
When using this product
Stop use and ask a doctor if symptoms persist
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away
Directions
- children 2 to under 6 years of age (with adult supervision): 2 or
- children under 2 years of age: consult a doctor
3 sprays in each nostril not more often than every 10 to 12
hours.
Use only recommended amount. Do not exceed 2
doses in any 24-hour period.
To Use: Shake well before use. Hold white tabs, press grooved area of cap firmly and turn counter clockwise. Before using the first time, prime metered pump by depressing pump firmly up to 10 times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke. Wipe nozzle clean after use. Secure cap after use.
Other Information
- store between 20° to 25°C (68° to 77°F)
- retain carton for future reference on full labeling
Inactive Ingredients
benzalkonium chloride, dibasic sodium phosphate, edetate disodium, glycerin, monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified water
Questions Or Comments?
Call 1-800-317-2165
Principal Display Panel - 15 Ml Bottle Carton
Oxymetazoline HCl Nasal Solution-Nasal Decongestant
Children's Afrin
®
No Drip EXtra Moisturizing Stuffy Nose Pump Mist
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