Guaifed

Guaifed is an FDA-registered drug product whose active ingredient is GUAIFENESIN. It is labelled by Aldama Pharmaceuticals, Inc taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 73564-801, application M012, label effective 20260810. 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.

Across FDA labelling, products containing GUAIFENESIN are most often described in connection with: helps loosen, phlegm mucus, thin bronchial, secretions make. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses: Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Directions take every 4 hours as needed, or as directed by doctor do not take more than 6 doses in 24 hours do not exceed recommended dose Age Dose adults and children 12 years and over 10 mL to 20 mL (2 to 4 teaspoonfuls) children under 12 years of age ask a doctor

Warnings Do not use: if you ever had an allergic reaction to any of the ingredients in this product ​ Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that last or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

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.

What is Guaifed used for?
Uses: Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Who makes Guaifed?
Aldama Pharmaceuticals, Inc is the labeler of record for Guaifed. 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 Guaifed 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 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 Guaifed 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.