AFRIN NO DRIP SEVERE CONGESTION- 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 Delpharm Montreal Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

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

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 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.

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.

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, camphor, edetate disodium, eucalyptol, menthol, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Questions or comments?

Call 1-800-317-2165

SPL UNCLASSIFIED SECTION

Distributed by Bayer HealthCare LLC Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

NDC: 11523-1350-1

Oxymetazoline HCl Nasal Solution-Nasal Decongestant

Afrin®

NoDrip

Won't drip from nose or down throat

Severe Congestion

PUMP MIST

Fast, Powerful

Congestion

Relief

Colds Allergies

12

Hour

Relief

Maximum

Strength

plus Menthol

#1 Doctor & Pharmacist

Recommended Brand

1/2 FL OZ (15 mL)

INGREDIENTS AND APPEARANCE

AFRIN NO DRIP  SEVERE CONGESTION
oxymetazoline hydrochloride spray, metered

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69213-1350
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 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
EUCALYPTOL (UNII: RV6J6604TK)
MENTHOL (UNII: L7T10EIP3A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69213-1350-1	1 in 1 CARTON	08/31/2000
1		15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 69213-1350-2	2 in 1 CARTON	08/31/2000
2		20 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3	NDC: 69213-1350-3	1 in 1 CARTON	08/31/2000
3		20 mL in 1 BOTTLE, PUMP; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/31/2000

Labeler - Famar Montreal Inc (203565379)