12 Hour Original Nasal Decongestant

NASAL SPRAY NASAL HUMAN OTC DRUG

12 Hour Original Nasal Decongestant is an FDA drug label for the active ingredient NASAL SPRAY manufactured by Sheffield Pharmaceuticals LLC 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 20231030.

Generic name
NASAL SPRAY
Manufacturer
Sheffield Pharmaceuticals LLC
Product type
HUMAN OTC DRUG
Route
NASAL
Dosage form
N/A
NDC
11527-140
Application
M012
Label effective
20231030

About this product

12 Hour Original Nasal Decongestant is an FDA-registered drug product whose active ingredient is NASAL SPRAY. It is labelled by Sheffield Pharmaceuticals LLC taken by nasal and marketed as a human otc drug product. Identifiers on file: NDC 11527-140, application M012, label effective 20231030. 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 SPRAY are most often described in connection with: tempoarily relieves, nasal congestion, due common, cold hay, fever sinusitis, upper respiroty, allergies shribnk, swollen membranes. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Drug Facts Active Ingredient Oxymetazoline Hydrochloride 0.05%

Indications & Usage

Uses Tempoarily relieves nasal congestion due to: common cold hay fever sinusitis upper respiroty allergies Shribnk swollen membranes so you can breathemore freely

Dosage & Administration

Adults and children 6 to under 12 years of age (with adult supervision):2 or 3 sprays in each nostril not more 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.To spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying, wipe nozzle clean after use.

Warnings

Warnings

Frequently asked questions

What is 12 Hour Original Nasal Decongestant used for?
Uses Tempoarily relieves nasal congestion due to: common cold hay fever sinusitis upper respiroty allergies Shribnk swollen membranes so you can breathemore freely

Who makes 12 Hour Original Nasal Decongestant?
Sheffield Pharmaceuticals LLC is the labeler of record for 12 Hour Original Nasal Decongestant.

What form does 12 Hour Original Nasal 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 12 Hour Original Nasal 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.

Has 12 Hour Original Nasal Decongestant been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.