MUCOSA

GUAIFENESIN ORAL HUMAN OTC DRUG

MUCOSA is an FDA drug label for the active ingredient GUAIFENESIN manufactured by TIME CAP LABORATORIES,INC administered by ORAL. 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 20231102.

Generic name
GUAIFENESIN
Manufacturer
TIME CAP LABORATORIES,INC
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
49483-272
Application
M012
Label effective
20231102

About this product

MUCOSA is an FDA-registered drug product whose active ingredient is GUAIFENESIN. It is labelled by TIME CAP LABORATORIES,INC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 49483-272, application M012, label effective 20231102. It is one of 98 FDA drug label records sharing the active ingredient GUAIFENESIN. 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 GUAIFENESIN are most often described in connection with: helps loosen, phlegm mucus, thin bronchial, secretions make, productive rid, passageway bothersome. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient (in each immediate-release tablet) Guaifenesin 400 mg

Indications & Usage

Uses helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus

Dosage & Administration

Directions adults and children 12 years of age and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours. children under 12 years of age: do not use

Warnings

Warnings Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by excessive phlegm (mucus) When using this product • do not exceed recommended dosage • do not use for more than 7 days Stop use and ask a doctor if • cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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How products containing GUAIFENESIN compare

FDA lists 98 drug label records with GUAIFENESIN 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
— — Bryant Ranch Prepack 4
— — Strategic Sourcing Services LLC 4
— — CVS Pharmacy 3
— — Cardinal Health 107, LLC 3
— — Reckitt Benckiser LLC 3

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-606-2013 Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister (NDC 63459-502-01), b) 30 count carton (NDC 63459-502-30), Rx only, Manufactured by: Cephalon, Inc., Salt Lake City, UT 84116 Teva Pharmaceuticals USA, Inc. Class II Terminated 20130626

Frequently asked questions

What is MUCOSA used for?
Uses helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus

Who makes MUCOSA?
TIME CAP LABORATORIES,INC is the labeler of record for MUCOSA. 98 FDA label records share the active ingredient GUAIFENESIN, 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 MUCOSA come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is MUCOSA 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 GUAIFENESIN?
Yes. 98 FDA drug label records list GUAIFENESIN 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 MUCOSA 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.