FDA Label for Major
View Indications, Usage & Precautions
Major Product Label
The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. 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.
Active Ingredient
Oxymetazoline hydrochloride 0.05%
Purpose
Nasal Decongestant
Uses
▪ temporarily relief of nasal congestion due to the▪ common cold▪ hay fever▪ other upper respiratory allergies▪ temporarily relieves sinus congestion and pressure▪ shrinks swollen nasal membranes so you can breathe more freely
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 at (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 use: Push firmly down on cap and turn counter clockwise.
To Spray: Squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Secure cap after use.
Other Information
▪ store at room temperature▪ Keep this carton for future reference on full labeling.
Inactive Ingredients
benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic.
Questions Or Comments?
1-866-467-2748
Principal Display Panel
MAJOR®
Compare to the active ingredient in Afrin® Original*
NDC# 0904-7006-35
Nasal Decongestant Spray
OXYMETAZOLINE HCL 0.05%
Original
Fast, Powerful Congestion Relief
For Colds & Allergies
Up to 12 Hour Relief
12 Hour Relief
Maximum Strength
NASAL DECONGESTANT
12 HOUR
1/2 FL OZ (15 mL)
TAMPER-EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS BROKEN OR MISSING.
Distributed by:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive
Suite 233
Livonia, MI 48152
This product starts to work in seconds providing up to 12 hours of nasal congestion relief without drowsiness.
Up to 12-hour relief from nasal congestion, Relief lasts All-Day or All-Night.
*This product is not manufactured or distributed by Bayer Healthcare LLC, distributer of Afrin® No Drip Original.
* Please review the disclaimer below.