Good Sense Cough DM

DEXTROMETHORPHAN POLISTIREX ORAL HUMAN OTC DRUG

Good Sense Cough DM is an FDA drug label for the active ingredient DEXTROMETHORPHAN POLISTIREX manufactured by L. Perrigo Company 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 20260827.

Generic name
DEXTROMETHORPHAN POLISTIREX
Manufacturer
L. Perrigo Company
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
0113-0958
Application
ANDA091135
Label effective
20260827

About this product

Good Sense Cough DM is an FDA-registered drug product whose active ingredient is DEXTROMETHORPHAN POLISTIREX. It is labelled by L. Perrigo Company taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 0113-0958, application ANDA091135, label effective 20260827. 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

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 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. Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. Ask a doctor before use if you have • chronic cough that lasts as occurs with smoking, asthma or emphysema • cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if • side effects occur. You may report side effects to FDA at 1-800-FDA-1088. • cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. 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).

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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

Recall and safety notices

5 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.

RecallProductFirmClassStatusReported
D-0912-2023 Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 36800-691-39), b)45-count cartons (NDC 36800-691-95), and 90-count cartons (NDC 36800-691-75), Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007. L. Perrigo Company Class II Terminated 20230719
D-0910-2023 allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 11673-617-22), b)30-count cartons (NDC 11673-617-39), c)70-count cartons (NDC 11673-617-01), and d)150-count cartons (11673-617-47), Distributed by: Target Corporation, Minneapolis, MN 55403. L. Perrigo Company Class II Terminated 20230719
D-0909-2023 allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39); and b) 45-count cartons (NDC 56062-847-95), Distributed by: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811. L. Perrigo Company Class II Terminated 20230719
D-0906-2023 allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 79481-0847-0), b)30-count cartons (NDC 79481-0847-1), and c) 45-count cartons (NDC 79481-0847-2), Distributed by: MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. L. Perrigo Company Class II Terminated 20230719
D-0903-2023 Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Distributed By: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 69842-0914-39 L. Perrigo Company Class II Terminated 20230719

Frequently asked questions

What is Good Sense Cough DM 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 Good Sense Cough DM?
L. Perrigo Company is the labeler of record for Good Sense Cough DM. 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 Good Sense Cough 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 Good Sense Cough 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.

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 Good Sense Cough DM been recalled?
5 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.

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.