Afrin Spray
FDA Label NDC 67751-185

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Navajo Manufacturing Company Inc. for the product Afrin (NDC 67751-185). 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 drug facts, active ingredient, purpose, uses, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Oxymetazoline hydrochloride 0.05%

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

Ask A Doctor Before Use If You Have

• heart disease • high blood pressure • diabetes • thyroid disease • trouble urinating due to an enlarged prostate gland

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

Stop Use And Ask A Doctor If

symptoms persist

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

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 spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

Other Information

  • store between 20° to 25°C (68° to 77°F)
  • retain card for future reference on full labeling
  • SAFETY SEALED: Do not use if "Afrin® Security Seal" imprinted on bottle is broken or missing

Inactive Ingredients

benzalkonium chloride solution, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Questions

Call 1-800-317-2165, M-F 8am-5pm

* Please review the disclaimer below.