DEXTROMETHORPHAN POLISTIREX

DEXTROMETHORPHAN POLISTIREX ORAL HUMAN OTC DRUG

DEXTROMETHORPHAN POLISTIREX is an FDA drug label for the active ingredient DEXTROMETHORPHAN POLISTIREX manufactured by Aurohealth LLC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260513.

Generic name
DEXTROMETHORPHAN POLISTIREX
Manufacturer
Aurohealth LLC
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
58602-617
Application
ANDA218417
Label effective
20260513

About this product

DEXTROMETHORPHAN POLISTIREX is an FDA-registered drug product whose active ingredient is DEXTROMETHORPHAN POLISTIREX. It is labelled by Aurohealth LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 58602-617, application ANDA218417, label effective 20260513. It is one of 27 FDA drug label records sharing the active ingredient DEXTROMETHORPHAN POLISTIREX. 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.

What it is used for

Across FDA labelling, products containing DEXTROMETHORPHAN POLISTIREX are most often described in connection with: temporarily relieves, cough due, minor throat, bronchial irritation, common cold, inhaled irritants, get sleep. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient (in each 5 mL) Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide USP

Indications & Usage

Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the impulse to cough to help you get to sleep

Dosage & Administration

Directions shake bottle well before use measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter adults and children 12 years of age and over 10 mL every 12 hours, not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours, not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours children under 4 years of age do not use

Warnings

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.

More products with the same ingredient

DEXTROMETHORPHAN POLISTIREX

12 HR RELIEF COUGH DM

CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED View label

12 hr relief cough dm

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How products containing DEXTROMETHORPHAN POLISTIREX compare

FDA lists 27 drug label records with DEXTROMETHORPHAN POLISTIREX 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.

Dosage formProductsManufacturerProducts
— — Amazon.com Services LLC 6
— — Aurohealth LLC 4
— — Safeway 4
— — CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 3
— — CVS Pharmacy 2

Frequently asked questions

What is DEXTROMETHORPHAN POLISTIREX used for?
Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the impulse to cough to help you get to sleep

Who makes DEXTROMETHORPHAN POLISTIREX?
Aurohealth LLC is the labeler of record for DEXTROMETHORPHAN POLISTIREX. 27 FDA label records share the active ingredient DEXTROMETHORPHAN POLISTIREX, 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 DEXTROMETHORPHAN POLISTIREX 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 DEXTROMETHORPHAN POLISTIREX 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 POLISTIREX?
Yes. 27 FDA drug label records list DEXTROMETHORPHAN POLISTIREX 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 DEXTROMETHORPHAN POLISTIREX 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.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.