Polytussin DM

Polytussin DM is an FDA-registered drug product whose active ingredient is DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, PYRILAMINE MALEATE. It is labelled by Poly Pharmaceuticals, Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 50991-132, application M012, label effective 20260818. 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, PHENYLEPHRINE HCL, PYRILAMINE MALEATE are most often described in connection with: temporarily relieves, symptoms due, common cold, hay fever, allergic rhinitis, upper respiratory, allergies runny, nose sneezing. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation nasal congestion reduces swelling of nasal passages

Directions Do not exceed recommended dosage. Adults and children 12 years of age and over: 2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 12 teaspoonfuls in 24 hours Children 6 to under 12 years of age:1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours Children under 6 years of age: Consult a doctor

Warnings Do not exceed recommended dosage. Do not use this product 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.

What is Polytussin DM used for?
Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation nasal congestion reduces swelling of nasal passages

Who makes Polytussin DM?
Poly Pharmaceuticals, Inc. is the labeler of record for Polytussin DM.

What form does Polytussin 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 Polytussin 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.

Has Polytussin 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.