Afrin Original Nasal — v3

Afrin Original Nasal

4 Views

Version

v3

Effective date

November 5, 2023

Original packager

—

Sections captured

15

Identifiers

Document ID
09734a55-efc5-3b22-e063-6394a90ad2d2
Set ID
af46c67d-f01f-83f8-e053-2a95a90aa70f
Application numbers
M012
Product NDCs
11523-1168
Package NDCs
11523-1168-6
Original packager NDCs
11523-1167

Names & Manufacturers

Brand names
Afrin Original Nasal
Generic names
OXYMETAZOLINE HYDROCHLORIDE
Manufacturer names
Bayer HealthCare LLC.
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
OXYMETAZOLINE HYDROCHLORIDE
Routes
NASAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
1000990, 1000992
UNII
K89MJ0S5VY
UPC
0731946010982

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient Oxymetazoline hydrochloride 0.05% Purpose Nasal decongestant
Ask Doctor (1)

Sequence 1

Ask a doctor before use if you have heart disease high blood pressure diabetes thyroid disease trouble urinating due to an enlarged prostate gland
Dosage And Administration (1)

Sequence 1

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.
Inactive Ingredient (1)

Sequence 1

Inactive ingredients benzalkonium chloride solution, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic
Indications And Usage (1)

Sequence 1

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
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)

Sequence 1

Package Labeling: Outer Package4 Inner Package4
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast-feeding, ask a health professional before use.
Purpose (1)

Sequence 1

Purpose Nasal decongestant
Questions (1)

Sequence 1

Questions or comments? Call 1-800-317-2165
Spl Product Data Elements (1)

Sequence 1

Afrin Original Nasal OXYMETAZOLINE HYDROCHLORIDE BENZALKONIUM CHLORIDE EDETATE DISODIUM POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SODIUM PHOSPHATE, DIBASIC SODIUM PHOSPHATE, MONOBASIC OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE
Spl Unclassified Section (2)

Sequence 1

Drug Facts

Sequence 2

Other information store between 20° to 25°C (68° to 77°F) retain carton for future reference on full labeling
Stop Use (1)

Sequence 1

Stop use and ask a doctor if symptoms persist
Warnings (1)

Sequence 1

Warnings 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.
When Using (1)

Sequence 1

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

OpenFDA raw payload

{'application_number': ['M012'],
 'brand_name': ['Afrin Original Nasal'],
 'generic_name': ['OXYMETAZOLINE HYDROCHLORIDE'],
 'manufacturer_name': ['Bayer HealthCare LLC.'],
 'original_packager_product_ndc': ['11523-1167'],
 'package_ndc': ['11523-1168-6'],
 'product_ndc': ['11523-1168'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['NASAL'],
 'rxcui': ['1000990', '1000992'],
 'spl_id': ['09734a55-efc5-3b22-e063-6394a90ad2d2'],
 'spl_set_id': ['af46c67d-f01f-83f8-e053-2a95a90aa70f'],
 'substance_name': ['OXYMETAZOLINE HYDROCHLORIDE'],
 'unii': ['K89MJ0S5VY'],
 'upc': ['0731946010982']}