Active Ingredients
0.05% Oxymetazoline Hydrochloride
Sinufrin Spray
FDA Label NDC 13709-231
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 (NDC 13709-231). 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 active ingredients, uses, warnings, directions for dosing, other information, inactive ingredients, principal display label, box label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
temporarily relieves nasal congestion due to: common cold n sinusitis, hay fever, upper respiratory allergies
temporarily relieves nasal congestion due to: common cold n sinusitis, hay fever, upper respiratory allergies.
Warnings
Do not exceed recommended dosage. This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge. The use of this container by more than one person may spread infection.
Do not use this product for more than 3 consecutive days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor. Do not use this product if you have heart disease, high blood pressure, thyroid disease or diabetes unless directed by a doctor.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Do not use this product for more than 3 consecutive days. Use only as directed. Frequent or prolonged use may
cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor. Do not use this product if you have heart disease, high
blood pressure, thyroid disease or diabetes unless directed by a doctor. Adult males with prostate disease, do not use this product.
Stop using this product for more than 3 consecutive days. Stop and ask your doctor if symptoms of nasal congestion persist after using 3 consecutive days.
If pregnant or breast-feeding, ask a health care professional before use.
Directions For Dosing
Adults and children 6 to 12 years of age (with adult supervision): Per dose, 2 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: consult a doctor.
Other Information
Store between 20 to 40 °C (68 to 104 °F)
Retain carton for future reference on full labeling
Keep head in an upright position for use. Do not tilt head backward while spraying. Wipe nozzle clean after each use.
Inactive Ingredients
Sodium chloride, sodium bicarbonate, propylene glycol, edetate disodium, benzalkonium chloride, purified water
Principal Display Label
Sinufrin Bottle Label (Label)
Box Label
Image Description (Box)
* Please review the disclaimer below.
