Maximum Strength Tussin DM Liquid filled Softgels

Maximum Strength Tussin DM Liquid filled Softgels is an FDA-registered drug product whose active ingredient is DEXTROMETHORPHAN HBR, GUAIFENESIN. It is labelled by AptaPharma Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 76281-601, application M012, label effective 20260510. It is one of 33 FDA drug label records sharing the active ingredient DEXTROMETHORPHAN HBR, 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 DEXTROMETHORPHAN HBR, GUAIFENESIN 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 cough more productive • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Directions • do not take more than 12 softgels in any 24-hour period • This product is not intended for use in children under 12 years • Adults & children 12 years and over - 2 softgels every 4 hours • Children under 12 years of age - do not use

Warnings

FDA lists 33 drug label records with DEXTROMETHORPHAN HBR, 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.

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 Maximum Strength Tussin DM Liquid filled Softgels used for?
Uses • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Who makes Maximum Strength Tussin DM Liquid filled Softgels?
AptaPharma Inc. is the labeler of record for Maximum Strength Tussin DM Liquid filled Softgels. 33 FDA label records share the active ingredient DEXTROMETHORPHAN HBR, 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 Maximum Strength Tussin DM Liquid filled Softgels 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 Maximum Strength Tussin DM Liquid filled Softgels 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 HBR, GUAIFENESIN?
Yes. 33 FDA drug label records list DEXTROMETHORPHAN HBR, 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 Maximum Strength Tussin DM Liquid filled Softgels 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.