FAMILY WELLNESS OXYMETAZOLINE SINUS SEVERE- oxymetazoline spray

Family Wellness Oxymetazoline Sinus Severe by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active Ingredient
Oxymetazoline Hydrochloride 0.05%

Purpose

Nasal Decongestant

Uses

Tempoarily relieves nasal congestion due to:

• common cold
• hay fever
• upper respirtory allergies
• temporaily relieves sinus congestion and pressure
• Shrinks swollen membranes so you can breathe more freely

Warnings 

Ask a Doctor before use if you have

• heart diease
• high blood pressure
• diabetes
• thyiod diease
• trouble urinating due to enlarged rostate 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

symptoms persist.

if pregnant 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.
• Before using for the first time, remove the protective cap form the tip and prime the 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 nostrile. Fully depress rim with a firm and even stroke, and sniff deeply.
  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, Benzyl Alcohol, Citric Acid Anhydrous, Disodium EDTA, Fragrance, Polysorbate 80, Sodium Citrate, Sorbitol, Water (Purified)

Principal Display Panel- Bottle 

Family Wellness                  NDC: 55319-827-30

Severe Nasal Spray 

Oxymetazoline HCL 0.05%

Nasal Decongestant 

1.0 FLOZ (30ml)

Principal Display panel -Carton 

Family Wellness NDC: 55319-827-30
Severe Nasal Spray

Oxymetazoline HCL 0.05%

Nasal Decongestant

1.0 FLOZ (30ml)

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS OXYMETAZOLINE SINUS SEVERE 
oxymetazoline spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-827
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
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-827-30	1 in 1 CARTON	09/30/2023
1		30 mL in 1 BOTTLE; 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	09/30/2023

Labeler - FAMILY DOLLAR (Family Wellness) (024472631)