FDA Label for Nasal
View Indications, Usage & Precautions
Nasal Product Label
The following document was submitted to the FDA by the labeler of this product Proficient Rx Lp. 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.
Other
Drug Facts
Active Ingredient
Oxymetazoline hydrochloride 0.05%
Purpose
Nasal decongestant
Uses
• for the temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies• shrinks swollen membranes so you can breathe more freely
Otc - Ask Doctor
Ask a doctor before use if you have
• heart disease• high blood pressure• thyroid disease• diabetes• trouble urinating due to enlarged prostate gland
Otc - When Using
When using this product
1. do not exceed recommended dosage2. do not use for more than 3 days. Use only as directed.3. may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge4. the use of this container by more than one person may spread infection5. frequent or prolonged use may cause nasal congestion to recur or worsen
Otc - Stop Use
Stop use and ask doctor if symptoms persist.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of 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 often than every 10 to 12 hours• do not exceed 2 doses within any 24-hour period• children under 6 years of age: consult a doctor
To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use
Storage And Handling
• store between 20° to 25° C (68° to 77° F)
Inactive Ingredients
benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate, edetate disodium, hydrochloric acid, monobasic sodium phosphate, polyethylene glycol 1450, povidone, propylene glycol, purified water
Questions?
To Report Adverse Drug Event Call: (800) 616-2471
Principal Display Panel - 15 Ml Carton
NDC 0904-5711-35
MAJOR®
Relabeled by:
Proficient Rx LP, Thousand Oaks, CA 91320
Soothing - 12 Hour
NASAL
DECONGESTANT
Spray
REGULAR
oxymetazoline
hydrochloride
0.05%
RELIEVES
CONGESTION
FAST
Compare to
active ingredient
of Afrin®
1/2 FL.OZ.
(15 mL)
* Please review the disclaimer below.
