Other
Drug Facts
Afrin Nodrip Allergy Sinus Night Spray
FDA Label NDC 11523-0034
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 Afrin Nodrip Allergy Sinus Night (NDC 11523-0034). 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, otc - active ingredient, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient Purpose
Oxymetazoline hydrochloride 0.05%…….…....Nasal decongestant
Indications & Usage
Uses
▪ temporarily relieves nasal congestion due to:
▪ common cold ▪hay fever
▪ upper respiratory allergies
▪ reduces swelling of nasal passages so you can breathe more freely
▪ temporarily relieves sinus congestion and pressure
Warnings
Warnings
Otc - Ask Doctor
▪ Ask a doctor before use if you have
▪ heart disease • high blood pressure
▪ thyroid disease ▪ diabetes
▪ trouble urinating due to an enlarged prostate gland
Otc - When Using
When using this product
▪ 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
Otc - Stop Use
Stop use and ask a doctor if symptoms persist
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
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: ask a doctor
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 several 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 and sniff deeply. Wipe nozzle clean after use. Secure cap after use.
Other Safety Information
Other information
▪ store between 20° to 25°C (68° to 77°F)
▪ retain carton for future reference on full labeling
Inactive Ingredient
Inactive ingredients benzalkonium chloride solution, benzyl alcohol, dibasic sodium phosphate, edetate disodium, flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, purified water
Otc - Questions
Questions or comments? 1-800-317-2165
Carton Label 15 Ml
Oxymetazoline HCl
Nasal Solution-Nasal Decongestant
AFRIN
NODRIP
Wont drive from nose or down throat
Allergy Sinus
Night
with soothing chamomile scent
PUMP MIST
Instant Congestion
Relief from Allergies
for a More Restful Night
Reduces
Swelling of
Nasal
Passages
1/2 FL OZ (15mL)
* Please review the disclaimer below.
