Label: AFRIN NODRIP ALLERGY SINUS NIGHT- oxymetazoline hydrochloride spray
- NDC Code(s): 11523-0034-1
- Packager: Bayer HealthCare LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated November 9, 2020
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
▪ 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
DOSAGE & ADMINISTRATION
▪ 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
▪ 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.
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- Carton label 15 mL
INGREDIENTS AND APPEARANCE
AFRIN NODRIP ALLERGY SINUS NIGHT
oxymetazoline hydrochloride spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-0034 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) POVIDONE (UNII: FZ989GH94E) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) BENZYL ALCOHOL (UNII: LKG8494WBH) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) HIBISCUS BIFURCATUS WHOLE (UNII: 60F5JKG79P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11523-0034-1 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/09/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/09/2020 Labeler - Bayer HealthCare LLC. (112117283)