Drug Facts
Drug Facts (6082 Enu Us Rev04 Sinufrinplus Label Page 0001)
- Active Ingredients- Oxymetazoline hydrochloride 0.05%
- Purpose- Nasal Decongestant
- Each full spray releases 0.1 mL of solution
Sinufrin Plus No Drip Decongestant Solution
FDA Label NDC 13709-356
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 Plus No Drip Decongestant (NDC 13709-356). 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, warnings when using this product, stop use and ask a doctor, if pregnant or breast-feeding, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Drug Facts (6082 Enu Us Rev04 Sinufrinplus Label Page 0001)
- Common cold
- Hay fever
- Upper respiratory allergies
- Temporarily relieves sinus congestion and pressure
- Shrinks swollen nasal membranes so you can breathe more freely
Temporarily relieves nasal congestion due
Drug Facts (6082 Enu Us Rev04 Sinufrinplus Label Page 0001)
Warnings
Drug Facts (6082 Enu Us Rev04 Sinufrinplus Label Page 0001)
Ask a doctor before use if you have
- Heart disease
- High blood pressure
- Diabetes
- Thyroid disease
- Trouble urinating due to an enlarged prostate gland
Warnings When Using This Product
Drug Facts (6082 Enu Us Rev04 Sinufrinplus Label Page 0001)
- 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
Drug Facts (6082 Enu Us Rev04 Sinufrinplus Label Page 0001)
Stop use and ask a doctor if symptoms persist
If Pregnant Or Breast-Feeding
If pregnant or breast-feeding, ask a health professional before use.
Drug Facts (6082 Enu Us Rev04 Sinufrinplus Label Page 0001)
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away
Drug Facts (6082 Enu Us Rev04 Sinufrinplus Label Page 0001)
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
Drug Facts (6082 Enu Us Rev04 Sinufrinplus Label Page 0001)
Other Information
- Store between 68° F (20° C) and 86° F (30° C)
- Retain carton for future reference on full labeling
Drug Facts (6082 Enu Us Rev04 Sinufrinplus Label Page 0001)
Inactive Ingredients
Propylene glycol, glycerin, sodium chloride, hyaluronic
acid, aloe vera, allantoin, sodium bicarbonate USP,
benzalkonium chloride, edetate disodium, purified water
Drug Facts (6082 Enu Us Rev04 Sinufrinplus Label Page 0001)
Questions/Concerns
Questions/Concerns 1 877 477 8633
Drug Facts (6082 Enu Us Rev04 Sinufrinplus Label Page 0001)
Product Name
NeilMed Sinufrin Plus
No Drip Decongestant
Relief for up to 12 hours
Moisturizing Gel with Sodium Hyaluronate and Aloe Vera
Oxymetazoline HCL Nasal Solution - Nasal Decongestant
plus Sodium Hyaluronate Hyaluronate and Aloe Vera
Quick Nasal Congestion Relief
12 Hour Relief
0.5 fl oz (15mL)
Drug Facts (6082 Enu Us Rev04 Sinufrinplus Label Page 0001)
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