Afrin ®

Afrin ®
SPL v16
SPL
SPL Set ID 346f32cb-74cb-4896-b770-76d5f829a17d
Route
NASAL
Published
Effective Date 2017-04-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.05 g)
Inactive Ingredients
Edetate Disodium Glycerin Cellulose, Microcrystalline Carboxymethylcellulose Sodium Polyethylene Glycol, Unspecified Povidone Water Sodium Phosphate, Dibasic Sodium Phosphate, Monobasic Benzalkonium Chloride Benzyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2000-08-31

Description

Drug Facts

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if symptoms persist

Section 53414-9

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

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.

Shake well before use. Before using the first time, remove the protective cap from the tip and 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.

Active Ingredient

Oxymetazoline hydrochloride 0.05%

Other Information
  • store between 20° to 25°C (68° to 77°F)
  • retain carton for future reference on full labeling
Inactive Ingredients

benzalkonium chloride solution, benzyl alcohol, edetate disodium, flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Questions Or Comments?

Call 1-800-317-2165

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
Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
Principal Display Panel 15 Ml Bottle Carton


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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms persist

Section 53414-9 (53414-9)

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

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.

Shake well before use. Before using the first time, remove the protective cap from the tip and 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.

Active Ingredient (Active ingredient)

Oxymetazoline hydrochloride 0.05%

Other Information (Other information)
  • store between 20° to 25°C (68° to 77°F)
  • retain carton for future reference on full labeling
Inactive Ingredients (Inactive ingredients)

benzalkonium chloride solution, benzyl alcohol, edetate disodium, flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Questions Or Comments? (Questions or comments?)

Call 1-800-317-2165

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
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
Principal Display Panel 15 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton)


Advanced Ingredient Data


Raw Label Data

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