AFRIN NO-DRIP ALLERGY SINUS- oxymetazoline hydrochloride spray, metered

Afrin No-Drip by

Drug Labeling and Warnings

Afrin No-Drip by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Oxymetazoline hydrochloride 0.05%

PURPOSE

Purpose

Nasal decongestant

INDICATIONS & 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

WARNINGS

Warnings

ASK DOCTOR

Ask a doctor before use if you have

● heart disease ● high blood pressure ● thyroid disease ● diabetes

● trouble urinating due to an enlarged prostate gland

WHEN USING

When using this product

● do not use more than directed

● do not use more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.

● temporary discomfort may occur 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

Stop use and ask a doctor if symptoms persist

PREGNANCY 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.

Directions

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. 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.

OTHER SAFETY INFORMATION

Other information

· store between 20°C to 25°C (68° to 77°F)

· retain carton for future reference on full labeling

INACTIVE INGREDIENT

Inactive ingredients benzalkonium chloride solution, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, 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

PRINCIPAL DISPLAY PANEL

Oxymetazoline HCl Nasal Solution-Nasal Decongestant

AFRIN

NoDrip

Won't drip from nose or down throat

Allergy Sinus

Pump Mist

Fast, Powerful

Congestion

Relief from

Allergies

up to 12 Hour Relief

Reduces

Swelling of

Nasal

Passages

#1 Doctor & Pharmacist Recommended Nasal Spray Brand

1/2FL OZ (15mL)

INGREDIENTS AND APPEARANCE

AFRIN NO-DRIP  ALLERGY SINUS
oxymetazoline hydrochloride spray, metered

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-3220
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.05 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CAMPHOR, (-)- (UNII: 213N3S8275)
EDETATE DISODIUM (UNII: 7FLD91C86K)
EUCALYPTOL (UNII: RV6J6604TK)
MENTHOL (UNII: L7T10EIP3A)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
POVIDONE (UNII: FZ989GH94E)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-3220-1	1 in 1 CARTON	08/30/2016
1		15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/30/2016

Labeler - Bayer HealthCare LLC (112117283)