FDA Label for Maximum Strength Nasal Decongestant

View Indications, Usage & Precautions

DRUG FACTS
PURPOSE
USES
ASK A DOCTOR BEFORE USE IF YOU HAVE
WHEN USING THIS PRODUCT
STOP USE AND ASK A DOCTOR IF
IF PREGNANT OR BREAST-FEEDING
KEEP OUT OF THE REACH OF CHILDREN
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
PRINCIPAL PANEL 0.5 FLOZ BOTTLE
PRINCIPAL DISPLAY PANEL- BOTTLE BACK LABEL
PRINCIPAL DISPLAY PANEL -CARTON

Maximum Strength Nasal Decongestant Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Health. 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 respiroty allergies
temporaily relieves sinus congestion and pressure
Shrinks swollen membranes so you can breathe more freely

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

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.
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.

Other Information

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

Inactive Ingredients

Benzalkonium Chloride Solution, Benzyl Alcohol, Camphor, Edetate Sodium, Eucalyptol, Glycerin, Menthol, Polysorbate 80, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic

Principal Panel 0.5 Floz Bottle

CVS Health Severe Congestion

Maxium Strength

Nasal Spray

Oxymetazoline HCL 0.05%

12 hour Nasal Spray

Net Wt 0.5 FLOZ (15ml)

Principal Display Panel -Carton