FAMILY WELLNESS OXYMETAZOLINE- oxymetazoline spray

Family Wellness Oxymetazoline by

Drug Labeling and Warnings

Family Wellness Oxymetazoline by is a Otc medication manufactured, distributed, or labeled by FAMILY DOLLAR (Family Wellness). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Fact 

Active Ingredient

Oxymetazoline HCL 0.05%

Purpose

Nasal Decongestant

Uses

Temporarily relieves nasal congestion due to:

• common cold
• hay fever
• sinusitis
• upper respiratory allergies
• shrinks swollen membranes so you can breathe more freely

Warnings

Ask a Doctor before use if you have

• heart diease
• high blood pressure
• diabetes
• thyroid disease
• trouble urinating due to enlarged prostate gland

When using this product

Do not use more than directed

• do not use for more than three 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

Systoms persist

PREGNANCY OR BREAST FEEDING

ask a health professional before use.

Keep out of the 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 than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
• Children under 6 years of age consult a doctor.To spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying, wipe nozzle clean after use.

Other Information

store between 20° and 25°C (68° to 77°F)
retain carton for future reference on full labeling

Inactive ingredients: 

benzalkonium chloride, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

Principal Display Panel -Bottle

Family Wellness Original Nasal Spray NDC: 55319-985-28
Oxymetazoline Hydrochloride 0.05%
12 hour Nasal Mist Nasal Decongestant

NET WT 1.0 FLOZ (30ml)

Principal Display Panel -Carton 

Family Wellness Original Nasal Spray NDC: 55319-985-28
Oxymetazoline Hydrochloride 0.05%
12 hour Nasal Mist Nasal Decongestant

NET WT 1.0 FLOZ (30ml)

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS OXYMETAZOLINE 
oxymetazoline spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-985
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	50 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
POVIDONE (UNII: FZ989GH94E)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-985-28	1 in 1 CARTON	10/02/2023
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 Drug	M012	10/02/2023

Labeler - FAMILY DOLLAR (Family Wellness) (024472631)