Drug Facts
Active Ingredients
Oxymetazoline hydrochloride 0.05%
Purpose- Nasal Decongestant
Sinufrin Decongestant Solution
FDA Label NDC 13709-355
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 Decongestant (NDC 13709-355). 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, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, when using this product, if pregnant or breast-feeding, keep out of reach of children, 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
- Hay fever
- Upper respiratory allergies
- Temporarily relieves sinus congestion and pressure
- Shrinks swollen nasal membranes so you can breathe more freely
Adults and children 6 to 12 years of age (with adult supervision)
Temporarily relieves nasal congestion due to:
Common cold n 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 n High blood pressure
- Thyroid disease
- Diabetes
- Trouble urinating due to an enlarged prostate gland
- 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 product by more than one person may spread infection
When using this product
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.
Ask A Doctor Before Use If You Have
Heart disease
High blood pressure
Thyroid disease
Diabetes
Trouble urinating due to an enlarged prostate gland
Stop Use And Ask A Doctor If
symptoms persist
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 product by more than one person may spread infection
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
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 n To use: To spray, squeeze bottle quickly and firmly. Keep head
upright and do not tilt head backward while spraying. Wipe nozzle clean after use.
Secure cap after use.
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
Dosage And Administration
Oxymetazoline hydrochloride 0.05%
Each full spray releases 0.1 mL of solution
Sodium chloride, sodium bicarbonate, propylene glycol, edetate disodium, benzalkonium chloride, purified water.
Do Not Use
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.
* Please review the disclaimer below.
