Children's Afrin ®

Children's Afrin ®
SPL v8
SPL
SPL Set ID e3231869-8ddf-9d17-e053-2995a90ae6d5
Route
NASAL
Published
Effective Date 2015-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-06

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

Warnings

Ask a doctor before use if you or a child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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 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.

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, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Questions Or Comments?

Call 1-800-317-2165

Keep Out of Reach of Children.

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

Principal Display Panel 15 Ml Bottle Carton

Oxymetazoline HCl Nasal Solution-Nasal Decongestant

Children's Afrin ®



No Drip EXtra Moisturizing Stuffy Nose Pump Mist





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

Purpose

Nasal decongestant

Warnings

Ask a doctor before use if you or a child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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 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.

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, 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

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

Principal Display Panel 15 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton)

Oxymetazoline HCl Nasal Solution-Nasal Decongestant

Children's Afrin ®



No Drip EXtra Moisturizing Stuffy Nose Pump Mist





Advanced Ingredient Data


Raw Label Data

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