GUAIFENESIN DM

GUAIFENESIN DM is an FDA-registered drug product whose active ingredient is GUAIFENESIN AND DEXTROMETHORPHAN. It is labelled by Cardinal Health 107, LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 55154-5783, application M012, label effective 20260602. It is one of 2 FDA drug label records sharing the active ingredient GUAIFENESIN AND DEXTROMETHORPHAN. 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 AND DEXTROMETHORPHAN are most often described in connection with: helps loosen, phlegm mucus, thin bronchial, secretions make, productive temporarily, relieves cough, due minor. 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 • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

DIRECTIONS: Follow dosage below or use as directed by a physician. • do not take more than 6 doses in any 24-hour period. age dose adults and children 12 years and over 10 mL (2 teaspoonfuls) every 4 hours children 6 years to under 12 years 5 mL (1 teaspoonful) every 4 hours children 2 years to under 6 years 2.5 mL (1/2 teaspoonful) every 4 hours children under 2 years ask a doctor

WARNINGS Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. • you are hypersensitive to any of the ingredients. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

FDA lists 2 drug label records with GUAIFENESIN AND DEXTROMETHORPHAN 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.

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.

What is GUAIFENESIN DM used for?
USES • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Who makes GUAIFENESIN DM?
Cardinal Health 107, LLC is the labeler of record for GUAIFENESIN DM. 2 FDA label records share the active ingredient GUAIFENESIN AND DEXTROMETHORPHAN, 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 GUAIFENESIN 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 GUAIFENESIN 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 GUAIFENESIN AND DEXTROMETHORPHAN?
Yes. 2 FDA drug label records list GUAIFENESIN AND DEXTROMETHORPHAN 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 GUAIFENESIN DM 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.