ORIGINAL- oxymetazoline hydrochloride spray

original by

Drug Labeling and Warnings

original by is a Otc medication manufactured, distributed, or labeled by Publix Super Markets Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
• 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. (1-800-222-1222)

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 spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Replace cap tightly to maintain child resistance.

Other information

• store at 20-25°C (68-77°F)
• retain carton for future reference on full labeling

Inactive ingredients

benzalkonium chloride solution, benzyl alcohol, dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified water

Principal Display Panel

SEE NEW DIRECTIONS

original

NASAL SPRAY

OXYMETAZOLINE HCl 0.05%

NASAL DECONGESTANT

12-HOUR SPRAY

COLDS – ALLERGIES

soothes as it relieves

fast, powerful congestion relief

Compare to Active Ingredient in Afrin® Original Nasal Spray

1 FL OZ (30 mL)

INGREDIENTS AND APPEARANCE

ORIGINAL 
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56062-304
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
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)

Product Characteristics
Color	WHITE (Translucent)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56062-304-10	1 in 1 CARTON	11/13/1991
1		30 mL in 1 BOTTLE, SPRAY; 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	11/13/1991

Labeler - Publix Super Markets Inc (006922009)