POLY-HIST DM

POLY-HIST DM is an FDA-registered drug product whose active ingredient is DEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBR. It is labelled by POLY PHARMACEUTICALS, INC. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 50991-271, application M012, label effective 20260423. 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 DEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBR are most often described in connection with: temporarily relieves, symptoms due, common cold, hay fever, allergic rhinitis, upper respiratory, allergies cough, minor throat. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

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

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 Ask a doctor before use if you have a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland heart disease high blood pressure thyroid disease diabetes Ask a doctor of pharmacist before use if you are taking sedatives or tranquilizers. When using this product excitability may occur, especially in children may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. nervousness, dizziness, or sleeplessness occur new symptoms occur If pregnant or breast-feeding, ask a health professional before use.

What is POLY-HIST DM used for?
Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: cough due to minor throat and bronchial irritation runny nose sneezing itching of nose or throat itchy, watery eyes

Who makes POLY-HIST DM?
POLY PHARMACEUTICALS, INC. is the labeler of record for POLY-HIST DM.

What form does POLY-HIST 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 POLY-HIST 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 POLY-HIST 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.