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Dextromethorphan Polistirex Extended-Release
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 |
|---|---|---|---|---|---|---|---|
| 203133-001 | DEXTROMETHORPHAN POLISTIREX | SUSPENSION, EXTENDED RELEASE | DEXTROMETHORPHAN POLISTIREX | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | July 28, 2017 | — |
Review documents
- 0 · Original application · September 24, 2021
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240627). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingINDICATIONS AND 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
Purpose
openFDA Drug LabelingOTC - PURPOSE Purpose Cough suppressant
Dosage and Administration
openFDA Drug LabelingDOSAGE AND 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 Other information each 5 mL contains: sodium 7 mg store at 20° to 25°C (68° to 77°F) dosing cup provided
Warnings
openFDA Drug LabelingWARNINGS Warnings
Do Not Use
openFDA Drug LabelingOTC - DO NOT USE 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.
Ask a Doctor
openFDA Drug LabelingOTC - ASK DOCTOR Ask a doctor before use if you have chronic cough that lasts such as occurs with smoking, asthma or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if 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 LabelingOTC - ACTIVE INGREDIENT Active 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 |
|---|---|---|---|---|
| 65162-700-76 | 65162-700 | Amneal Pharmaceuticals LLC | 1 BOTTLE in 1 CARTON (65162-700-76) / 89 mL in 1 BOTTLE | August 1, 2017 |
| 65162-700-77 | 65162-700 | Amneal Pharmaceuticals LLC | 1 BOTTLE in 1 CARTON (65162-700-77) / 148 mL in 1 BOTTLE | August 1, 2017 |
| 65162-799-76 | 65162-799 | Amneal Pharmaceuticals LLC | 1 BOTTLE in 1 CARTON (65162-799-76) / 89 mL in 1 BOTTLE | August 1, 2017 |
| 65162-799-77 | 65162-799 | Amneal Pharmaceuticals LLC | 1 BOTTLE in 1 CARTON (65162-799-77) / 148 mL in 1 BOTTLE | August 1, 2017 |
| 65162-700 | 65162-700 | Amneal Pharmaceuticals LLC | — | August 1, 2017 |
| 65162-799 | 65162-799 | Amneal Pharmaceuticals LLC | — | August 1, 2017 |
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.