Robitussin 12 Hour Cough Relief

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Robitussin 12 Hour Cough Relief
Generic name
DEXTROMETHORPHAN POLISTIREX
Manufacturer
Haleon US Holdings LLC
Product type
HUMAN OTC DRUG
SPL set ID
5d12a1b8-f1fb-41ca-9a4f-0595a585cbb5
SPL ID
159a0a07-055f-e1e2-e063-6394a90a9a37
Version
7
Effective date
2024-04-08
Source export date
2026-10-27
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-27/be847f9aea8d80a2cb7e9771acd1143be084664192ecf8f5be8ac1024116f4f0/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run
20261027T193451Z
Imported at
2026-10-27 20:12:40
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.