Guaifed DM
Guaifed DM is an FDA drug label for the active ingredient DEXTROMETHORPHAN, GUAIFENESIN manufactured by Aldama Pharmaceuticals, 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 20260810.
- Generic name
- DEXTROMETHORPHAN, GUAIFENESIN
- Manufacturer
- Aldama Pharmaceuticals, Inc
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 73564-802
- Application
- M012
- Label effective
- 20260810
About this product
Guaifed DM is an FDA-registered drug product whose active ingredient is DEXTROMETHORPHAN, GUAIFENESIN. It is labelled by Aldama Pharmaceuticals, Inc taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 73564-802, application M012, label effective 20260810. It is one of 3 FDA drug label records sharing the active ingredient DEXTROMETHORPHAN, 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 DEXTROMETHORPHAN, GUAIFENESIN are most often described in connection with: temporarily relieves, coiugh due, minor throat, bronchial irritation, helps loosen, phlegm mucus, secretions make. 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 coiugh due to minor throat and bronchial irritation Helps loosen phlegm (mucus) helps thin bronchial secretions to make coughs more productive.
Dosage & Administration
Directions do not exceed recommended dosage take every 4 hours as needed, or as directed by doctor do not take more than 6 doses in 24 hours Age Dose adults and children 12 years and over 10 mL (2 teaspoonfuls) children under 12 years Do not use
Warnings
Warnings Do not use: if you are now takin a prescription monoamine oxidase inhibidor (MAOI) (certain drugs for deression, psychiatric or emotional conditions, or Parkinson's disease, or for two weeks after stoping the MAOI drug. If you do not know if nyour prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
More products with the same ingredient
DEXTROMETHORPHAN, GUAIFENESINHow products containing DEXTROMETHORPHAN, GUAIFENESIN compare
FDA lists 3 drug label records with DEXTROMETHORPHAN, 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 form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | Aldama Pharmaceuticals, Inc | 1 |
| — | — | RMT HEALTH LLC | 1 |
| — | — | Southern Sales & Service, Inc. | 1 |
| — | — | — | — |
| — | — | — | — |
Frequently asked questions
What is Guaifed DM used for?
Uses: Temporarily relieves coiugh due to minor throat and bronchial irritation Helps loosen phlegm (mucus) helps thin bronchial secretions to make coughs more productive.
Who makes Guaifed DM?
Aldama Pharmaceuticals, Inc is the labeler of record for Guaifed DM. 3 FDA label records share the active ingredient DEXTROMETHORPHAN, 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 Guaifed DM 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 Guaifed DM 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 DEXTROMETHORPHAN, GUAIFENESIN?
Yes. 3 FDA drug label records list DEXTROMETHORPHAN, 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 Guaifed DM 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.