afrin

afrin
SPL v5
SPL
SPL Set ID 65bf1556-f234-9439-e053-2a91aa0a3194
Route
topical
Published
Effective Date 2018-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
oxymetazoline (0.05 g)
Inactive Ingredients
edetate disodium polyethylene glycol, unspecified povidone propylene glycol water sodium phosphate, dibasic, anhydrous sodium phosphate, monobasic, anhydrous

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2017-12-04

Purpose

Nasal decongestant

Description

Oxymetazoline hydrochloride 0.05%


Medication Information

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
Purpose

Nasal decongestant

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

Description

Oxymetazoline hydrochloride 0.05%

Drug Facts

questions

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

Package Labeling:

Active Ingredient 

Oxymetazoline hydrochloride 0.05%

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.

Ask A Doctor Before Use If You Have

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


Structured Label Content

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
Purpose

Nasal decongestant

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 (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 (Inactive ingredients)

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

Drug Facts

questions (Questions)

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

Package Labeling:

Active Ingredient  (Active ingredient )

Oxymetazoline hydrochloride 0.05%

When Using This Product (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 (Stop use and ask a doctor if)

symptoms persist

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)