Tussin DM Regular

Tussin DM Regular is an FDA-registered drug product whose active ingredient is DEXTROMETHORPHAN HBR AND GUAIFENESIN. It is labelled by AARNA USA, Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 82568-0014, application M012, label effective 20260616. It is one of 7 FDA drug label records sharing the active ingredient DEXTROMETHORPHAN HBR AND 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 AND GUAIFENESIN are most often described in connection with: temporarily relieves, cough due, minor throat, bronchial irrttation, occur wtth, cold helps, loosen phlegm, secretions drain. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporarily relieves cough due to minor throat and bronchial irrttation as may occur wtth a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Directions do not take more than 6 doses in any 24-hour period mL= milliliter this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 10 mL every 4 hours children under 12 years do not use

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. tt you do not know tt 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. 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 (1-800-222-1222).

FDA lists 7 drug label records with DEXTROMETHORPHAN HBR AND 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 Tussin DM Regular used for?
Uses temporarily relieves cough due to minor throat and bronchial irrttation as may occur wtth a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Who makes Tussin DM Regular?
AARNA USA, Inc. is the labeler of record for Tussin DM Regular. 7 FDA label records share the active ingredient DEXTROMETHORPHAN HBR AND 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 Tussin DM Regular 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 Tussin DM Regular 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 AND GUAIFENESIN?
Yes. 7 FDA drug label records list DEXTROMETHORPHAN HBR AND 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 Tussin DM Regular 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.