Sinufrin Decongestant

NASAL CONGESTION RELIEF NASAL HUMAN OTC DRUG

Sinufrin Decongestant is an FDA drug label for the active ingredient NASAL CONGESTION RELIEF manufactured by NeilMed Pharmaceuticals Inc administered by NASAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260525.

Generic name
NASAL CONGESTION RELIEF
Manufacturer
NeilMed Pharmaceuticals Inc
Product type
HUMAN OTC DRUG
Route
NASAL
Dosage form
N/A
NDC
13709-355
Application
M012
Label effective
20260525

About this product

Sinufrin Decongestant is an FDA-registered drug product whose active ingredient is NASAL CONGESTION RELIEF. It is labelled by NeilMed Pharmaceuticals Inc taken by nasal and marketed as a human otc drug product. Identifiers on file: NDC 13709-355, application M012, label effective 20260525. It is one of 2 FDA drug label records sharing the active ingredient NASAL CONGESTION RELIEF. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing NASAL CONGESTION RELIEF are most often described in connection with: temporarily relieves, children years, adult supervision, nasal congestion, due common, cold hay, fever upper, respiratory allergies. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Drug Facts Active Ingredients Oxymetazoline hydrochloride 0.05% Purpose- Nasal Decongestant Drug Facts

Indications & Usage

Uses 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 Indications and Usage

Dosage & Administration

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. Dosage

Warnings

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 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 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. Warnings

More products with the same ingredient

NASAL CONGESTION RELIEF

Sinufrin Plus No Drip Decongestant

NeilMed Pharmaceuticals Inc View label

How products containing NASAL CONGESTION RELIEF compare

FDA lists 2 drug label records with NASAL CONGESTION RELIEF as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — NeilMed Pharmaceuticals Inc 2
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— — — —
— — — —
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Recall and safety notices

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-0569-2024 SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12 Hour Relief, 0.5 fl oz (15 ml) bottle, Manufactured by NeilMed Pharmaceuticals Inc, 602 Aviation Blvd, Santa Rosa, CA 95403 877-477-8633; NDC 13709-325-01; UPC 7 05928 09001 9. Neilmed Pharmaceuticals Inc Class III Ongoing 20240703

Frequently asked questions

What is Sinufrin Decongestant used for?
Uses 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 Indications and Usage

Who makes Sinufrin Decongestant?
NeilMed Pharmaceuticals Inc is the labeler of record for Sinufrin Decongestant. 2 FDA label records share the active ingredient NASAL CONGESTION RELIEF, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Sinufrin Decongestant come in?
administered by nasal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Sinufrin Decongestant prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing NASAL CONGESTION RELIEF?
Yes. 2 FDA drug label records list NASAL CONGESTION RELIEF as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Sinufrin Decongestant been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.