Guaifenesin,Dextromethorphan Hbr
Guaifenesin,Dextromethorphan Hbr is an FDA drug label for the active ingredient GUAIFENESIN,DEXTROMETHORPHAN HBR manufactured by Softgel Healthcare Pvt Ltd 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 20260427.
- Generic name
- GUAIFENESIN,DEXTROMETHORPHAN HBR
- Manufacturer
- Softgel Healthcare Pvt Ltd
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 35916-0759
- Application
- M012
- Label effective
- 20260427
About this product
Guaifenesin,Dextromethorphan Hbr is an FDA-registered drug product whose active ingredient is GUAIFENESIN,DEXTROMETHORPHAN HBR. It is labelled by Softgel Healthcare Pvt Ltd taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 35916-0759, application M012, label effective 20260427. 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,DEXTROMETHORPHAN HBR are most often described in connection with: temporarily relieves, cough due, minor throat, bronchial irritation, cold helps, loosen phlegm, secretions rid, passageways bothersome. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Dosage & Administration
Directions do not exceed 6 doses in 24 hours take with a full glass of water adults and children 12 years of age and over: take 1 softgel every 4 hours children under 12 years of age: do not use
Warnings
Warnings
Frequently asked questions
What is Guaifenesin,Dextromethorphan Hbr used for?
Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Who makes Guaifenesin,Dextromethorphan Hbr?
Softgel Healthcare Pvt Ltd is the labeler of record for Guaifenesin,Dextromethorphan Hbr.
What form does Guaifenesin,Dextromethorphan Hbr 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 Guaifenesin,Dextromethorphan Hbr 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 Guaifenesin,Dextromethorphan Hbr 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.