FDA Label for Family Wellness Oxymetazoline Sinus Severe
View Indications, Usage & Precautions
Family Wellness Oxymetazoline Sinus Severe Product Label
The following document was submitted to the FDA by the labeler of this product Family Dollar (family Wellness). The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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)
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