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CareOne 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 20200701). 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 • 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
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
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 |
|---|---|---|---|---|
| 41520-384-21 | 41520-384 | American Sales Company | 1 BOTTLE in 1 CARTON (41520-384-21) / 89 mL in 1 BOTTLE | August 30, 2012 |
| 41520-958-21 | 41520-958 | American Sales Company | 1 BOTTLE in 1 CARTON (41520-958-21) / 89 mL in 1 BOTTLE | August 23, 2013 |
| 41520-384 | 41520-384 | American Sales Company | — | August 30, 2012 |
| 41520-958 | 41520-958 | American Sales Company | — | August 23, 2013 |
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 · 10 sections on this page.