Drug Facts Active Ingredients
Oxymetazoline hydrochloride 0.04%
Sinufrin Quick Relief Decongestant Spray
FDA Label NDC 13709-325
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals Inc. for the product Sinufrin Quick Relief Decongestant (NDC 13709-325). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts active ingredients, purpose, uses:, warnings, when using this product, directions, other safety information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nasal Decongestant
Uses:
- Temporarily relieves nasal congestion due to:
- Common cold
- Hay fever
- Upper respiratory allergies
- Temporarily relieves sinus congestion and pressure
- Shrinks swollen nasal membranes so you can breathe more freely
Warnings
Ask a doctor before use if you have
- Heart disease
- High blood pressure
- Diabetes
- Thyroid disease
- Trouble urinating due to an enlarged prostate gland
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.
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.
Directions
- Adults and children 6 to under 12 years of age (with adult supervision): 3 or 4 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 Safety Information
Other Information
- Store between 68° F (20° C) and 86° F (30° C)
- Retain carton for future reference on full labeling
Inactive Ingredients
Sodium chloride, sodium bicarbonate, propylene glycol, edetate disodium, benzalkonium chloride, purified water.
* Please review the disclaimer below.
