Afrin Allergy Sinus Nasal Spray Ui1612342

Afrin Allergy Sinus Nasal Spray Ui1612342
SPL v7
SPL
SPL Set ID c2d903bf-5c51-82d7-e053-2995a90aea49
Route
NASAL
Published
Effective Date 2016-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.5 g)
Inactive Ingredients
Benzyl Alcohol Eucalyptol Propylene Glycol Sodium Phosphate, Monobasic Sodium Phosphate, Dibasic Benzalkonium Chloride Camphor (synthetic) Edetate Disodium Menthol Polysorbate 80 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-08-26

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

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

Dosage and 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: Push firmly down on cap and turn counter clockwise. To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Secure cap after use.

Description

Drug Facts

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 50567-7

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
Section 50569-3

Ask a doctor before use if you have

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

Section 51727-6

Inactive ingredients benzalkonium chloride solution, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, polysorbate 80, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Section 53413-1

Questions or comments? 1-800-317-2165

Section 53414-9

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

Section 55106-9

Active ingredient Purpose

Oxymetazoline hydrochloride 0.05%…….…....Nasal decongestant

Section 60561-8

Other information

  • store between 20º to 25ºC (68º to 77ºF)
  • retain carton for future reference on full labeling
15 Ml Carton

Afrin

Oxymetazoline HCl Nasal Solution-Nasal Decongestant

Allergy Sinus

Nasal Spray

Fast, Powerful

Congestion

Relief From

Allergies

up to

12 HOUR

RELIEF

Reduces

Swelling of

Nasal

Packages

#1 Doctor &

Pharmacist Recommended

Nasal Spray Brand

1/2 FL OZ (15 mL)


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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: Push firmly down on cap and turn counter clockwise. To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Secure cap after use.

Warnings and Precautions (34071-1)

Warnings

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 50567-7 (50567-7)

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
Section 50569-3 (50569-3)

Ask a doctor before use if you have

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

Section 51727-6 (51727-6)

Inactive ingredients benzalkonium chloride solution, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, polysorbate 80, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Section 53413-1 (53413-1)

Questions or comments? 1-800-317-2165

Section 53414-9 (53414-9)

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

Section 55106-9 (55106-9)

Active ingredient Purpose

Oxymetazoline hydrochloride 0.05%…….…....Nasal decongestant

Section 60561-8 (60561-8)

Other information

  • store between 20º to 25ºC (68º to 77ºF)
  • retain carton for future reference on full labeling
15 Ml Carton (15 mL Carton)

Afrin

Oxymetazoline HCl Nasal Solution-Nasal Decongestant

Allergy Sinus

Nasal Spray

Fast, Powerful

Congestion

Relief From

Allergies

up to

12 HOUR

RELIEF

Reduces

Swelling of

Nasal

Packages

#1 Doctor &

Pharmacist Recommended

Nasal Spray Brand

1/2 FL OZ (15 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)