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Cough DM
dextromethorphan polistirex · Suspension
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Dextromethorphan Hydrobromide | 30 mg/5mL | 1094538 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Sigma-1 Agonist [EPC] | EPC | All 44 members |
| Sigma-1 Receptor Agonists [MoA] | MoA | All 44 members |
| Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC] | EPC | All 44 members |
| Uncompetitive NMDA Receptor Antagonists [MoA] | MoA | All 44 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 091135-001 | DEXTROMETHORPHAN POLISTIREX | SUSPENSION, EXTENDED RELEASE | DEXTROMETHORPHAN POLISTIREX | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 2 | Manufacturing (CMC) | Approved | October 27, 2014 | — |
| Supplement | 1 | Manufacturing (CMC) | Approved | September 28, 2012 | — |
| Original application | 1 | Approved | May 25, 2012 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250926). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses 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
Purpose
openFDA Drug LabelingPurpose Cough suppressant
Dosage and Administration
openFDA Drug LabelingDirections • 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 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 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).
Warnings
openFDA Drug LabelingWarnings 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).
Do Not Use
openFDA Drug LabelingDo 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
openFDA Drug LabelingAsk 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
openFDA Drug LabelingStop 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.
Active Ingredient
openFDA Drug LabelingActive ingredient (in each 5 mL) Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: DEXTROMETHORPHAN HYDROBROMIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 17856-6312-1 | 17856-6312 | ATLANTIC BIOLOGICALS CORP. | 5 mL in 1 CUP (17856-6312-1) | November 18, 2024 |
| 17856-6312-2 | 17856-6312 | ATLANTIC BIOLOGICALS CORP. | 10 mL in 1 CUP (17856-6312-2) | November 18, 2024 |
| 72288-652-28 | 72288-652 | Amazon.com Services LLC | 1 BOTTLE in 1 CARTON (72288-652-28) / 148 mL in 1 BOTTLE (72288-652-00) | August 13, 2026 |
| 59779-384-21 | 59779-384 | CVS Pharmacy | 1 BOTTLE in 1 CARTON (59779-384-21) / 89 mL in 1 BOTTLE | August 28, 2012 |
| 59779-384-28 | 59779-384 | CVS Pharmacy | 1 BOTTLE in 1 CARTON (59779-384-28) / 148 mL in 1 BOTTLE | July 18, 2013 |
| 59779-958-21 | 59779-958 | CVS Pharmacy | 1 BOTTLE in 1 CARTON (59779-958-21) / 89 mL in 1 BOTTLE | July 16, 2013 |
| 59779-958-28 | 59779-958 | CVS Pharmacy | 1 BOTTLE in 1 CARTON (59779-958-28) / 148 mL in 1 BOTTLE | December 27, 2013 |
| 37808-384-21 | 37808-384 | H E B | 1 BOTTLE in 1 CARTON (37808-384-21) / 89 mL in 1 BOTTLE | August 30, 2012 |
| 37808-384-28 | 37808-384 | H E B | 1 BOTTLE in 1 CARTON (37808-384-28) / 148 mL in 1 BOTTLE | April 13, 2016 |
| 42507-384-21 | 42507-384 | HyVee Inc | 1 BOTTLE in 1 CARTON (42507-384-21) / 89 mL in 1 BOTTLE (42507-384-00) | September 2, 2012 |
| 42507-384-28 | 42507-384 | HyVee Inc | 1 BOTTLE in 1 CARTON (42507-384-28) / 148 mL in 1 BOTTLE (42507-384-01) | August 5, 2013 |
| 30142-384-21 | 30142-384 | Kroger Company | 1 BOTTLE in 1 CARTON (30142-384-21) / 89 mL in 1 BOTTLE | August 28, 2012 |
| 0904-6312-56 | 0904-6312 | Major Pharmaceuticals | 1 BOTTLE in 1 CARTON (0904-6312-56) / 89 mL in 1 BOTTLE | September 6, 2012 |
| 41250-384-28 | 41250-384 | Meijer Distribution Inc | 1 BOTTLE in 1 CARTON (41250-384-28) / 148 mL in 1 BOTTLE | July 31, 2013 |
| 41250-899-28 | 41250-899 | Meijer Distribution Inc | 1 BOTTLE in 1 CARTON (41250-899-28) / 148 mL in 1 BOTTLE | March 25, 2015 |
| 41250-958-28 | 41250-958 | Meijer Distribution Inc | 1 BOTTLE in 1 CARTON (41250-958-28) / 148 mL in 1 BOTTLE | July 31, 2013 |
| 56062-384-21 | 56062-384 | Publix Super Markets Inc | 1 BOTTLE in 1 CARTON (56062-384-21) / 89 mL in 1 BOTTLE | February 25, 2014 |
| 21130-538-21 | 21130-538 | Safeway | 1 BOTTLE in 1 CARTON (21130-538-21) / 89 mL in 1 BOTTLE | May 4, 2026 |
| 0363-0384-21 | 0363-0384 | Walgreen Company | 1 BOTTLE in 1 CARTON (0363-0384-21) / 89 mL in 1 BOTTLE | August 28, 2012 |
| 0363-0384-28 | 0363-0384 | Walgreen Company | 1 BOTTLE in 1 CARTON (0363-0384-28) / 148 mL in 1 BOTTLE | July 16, 2013 |
| 17856-6312 | 17856-6312 | ATLANTIC BIOLOGICALS CORP. | — | September 6, 2012 |
| 72288-652 | 72288-652 | Amazon.com Services LLC | — | August 13, 2026 |
| 59779-384 | 59779-384 | CVS Pharmacy | — | August 28, 2012 |
| 59779-958 | 59779-958 | CVS Pharmacy | — | July 16, 2013 |
| 37808-384 | 37808-384 | H E B | — | August 30, 2012 |
| 42507-384 | 42507-384 | HyVee Inc | — | September 2, 2012 |
| 30142-384 | 30142-384 | Kroger Company | — | August 28, 2012 |
| 0904-6312 | 0904-6312 | Major Pharmaceuticals | — | September 6, 2012 |
| 41250-384 | 41250-384 | Meijer Distribution Inc | — | August 27, 2012 |
| 41250-899 | 41250-899 | Meijer Distribution Inc | — | March 25, 2015 |
| 41250-958 | 41250-958 | Meijer Distribution Inc | — | July 8, 2013 |
| 56062-384 | 56062-384 | Publix Super Markets Inc | — | February 25, 2014 |
| 21130-538 | 21130-538 | Safeway | — | May 4, 2026 |
| 0363-0384 | 0363-0384 | Walgreen Company | — | August 28, 2012 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 11 sections on this page.