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Robitussin 12 Hour Cough Relief

dextromethorphan polistirex · Suspension, Extended Release

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Robitussin 12 Hour Cough Relief
Generic name
dextromethorphan polistirex
Dosage form
Suspension, Extended Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Haleon US Holdings LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
4
Packages
4
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Dextromethorphan Hydrobromide 30 mg/5mL 1094538 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Suspension, Extended Release
Route of administration
Oral
Presentations
8

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
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
Application number
091135
Application type
ANDA · Abbreviated New Drug Application
Approval date
May 25, 2012
Sponsor
TRIS PHARMA INC
Products on application
1
Submissions recorded
3
Products approved under application 091135.
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
Most recent submissions on application 091135.
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 —

Review documents

  • 0 · Original application · May 17, 2017
  • 0 · Original application · May 30, 2012

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240408). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20240408

Indications and Usage

openFDA Drug Labeling

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 Cough suppressant

Dosage and Administration

openFDA Drug Labeling

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 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 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 Labeling

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.

Active Ingredient

openFDA Drug Labeling

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

Adverse event reports

Source: openFDA FAERS
50,236
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed 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
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0031-8655-10 0031-8655 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0031-8655-10) / 89 mL in 1 BOTTLE July 1, 2015
0031-8753-03 0031-8753 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0031-8753-03) / 89 mL in 1 BOTTLE July 1, 2015
0031-8754-15 0031-8754 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0031-8754-15) / 148 mL in 1 BOTTLE July 5, 2016
0031-8755-15 0031-8755 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0031-8755-15) / 148 mL in 1 BOTTLE July 5, 2016
0031-8655 0031-8655 Haleon US Holdings LLC — July 1, 2015
0031-8753 0031-8753 Haleon US Holdings LLC — July 1, 2015
0031-8754 0031-8754 Haleon US Holdings LLC — July 5, 2016
0031-8755 0031-8755 Haleon US Holdings LLC — July 5, 2016

Sources for this page

Every dataset that contributed a fact to 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.