FDA.reportPublic FDA data

Robitussin Maximum Strength Severe Cough Plus Sore Throat

Manufacturer
Haleon US Holdings LLC
Effective date
2025-11-13
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:16:07

Label at a glance#

ProductRobitussin Maximum Strength Severe Cough Plus Sore Throat
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms occurring with a cold or flu: cough due to minor throat and bronchial irritation minor aches and pains sore throat pain headache temporarily reduces fever

Dosage and administration

do not take more than 6 doses in any 24-hour period do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. measure only with dosing cup provided keep dosing cup with product mL = milliliter this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 20 mL every 4 hours children under 12 years...

Storage and handling

each 20 mL contains: sodium 13 mg store at 20-25°C (68-77°F). Do not refrigerate.

Label contents#

Full prescribing information#

Active ingredients (in each 20 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen, 650 mg

Dextromethorphan HBr, 20 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms occurring with a cold or flu:
    • cough due to minor throat and bronchial irritation
    • minor aches and pains
    • sore throat pain
    • headache
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 6 doses in any 24-hour period, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

SPL UNCLASSIFIED SECTION

Allergy alert:acetaminophen may cause severe skin reactions.
Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

SPL UNCLASSIFIED SECTION

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

  • 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.
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, or emphysema

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking any other pain reliever/fever reducer

OTC - WHEN USING SECTION

When using this product do not use more than directed.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24-hour period
  • do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • this adult product is not intended for use in children under 12 years of age
agedose

adults and children 12 years and over

20 mL every 4 hours

children under 12 years

do not use

Other information

STORAGE AND HANDLING SECTION

  • each 20 mL contains:sodium 13 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C red no. 40, glycerin, menthol, natural & artificial flavor, polyethylene glycol, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

call weekdays from 8 AM to 6 PM EST at 1-800-245-1040

SPL UNCLASSIFIED SECTION

Dist. by: GSK CH, Warren, NJ 07059

For most recent product information,

visit www.robitussin.com

Trademarks owned or licensed by GSK

©2022 GSK or licensor Made in Mexico

000065356 Front Carton

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ADULT

Robitussin

MAXIMUM STRENGTH

SEVERE
Cough +
Sore Throat

ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves:

Cough

Sore Throat Pain

Strong Cooling Liquid
Non-Drowsy

POWERFUL
SORE THROAT
Relief

CF
MAX

For Ages 12 & Over

4 FL OZ (118 mL)

Robitussin MS Severe C+ST 4 fl oz (118 ml)
Robitussin MS Severe C+ST 4 fl oz (118 ml)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1919076acetaminophen 325 MG / dextromethorphan HBr 10 MG in 10 mL Oral SolutionPSN11
1919076acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD11
1919076acetaminophen 325 MG / dextromethorphan HBr 10 MG per 10 mL Oral SolutionSY11
1919076acetaminophen 650 MG / dextromethorphan HBr 20 MG per 20 mL Oral SolutionSY11
1919076APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral SolutionSY11

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-8750-12Robitussin Maximum Strength Severe Cough Plus Sore Throat118 mL in 1 BOTTLELIQUID11811
0031-8750-12Robitussin Maximum Strength Severe Cough Plus Sore Throat1 in 1 CARTONLIQUID111
0031-8750-18Robitussin Maximum Strength Severe Cough Plus Sore Throat1 in 1 CARTONLIQUID111
0031-8750-18Robitussin Maximum Strength Severe Cough Plus Sore Throat237 mL in 1 BOTTLELIQUID23711

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0031-8750-12ML - Milliliter0031-8750999c0b22-960e-42da-9a18-a0948763bc9e12020-05-08
0031-8750-18ML - Milliliter0031-8750cf497560-869d-468f-ad8a-e65a1bb6460e12020-06-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0031-87500031-8750-12, 0031-8750-18

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Robitussin Maximum Strength Severe Cough Plus Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC6a6f5da8-6433-4284-8df7-2d5b099b74dc2025-11-13WarningsExact identifier
ndc (package): 0031-8750-18
ndc (package): 0031-8750-12
ndc (product): 0031-8750
ndc11 (package): 00031875018
ndc11 (package): 00031875012
spl id: 4380fed9-2211-3875-e063-6394a90ab5ea
spl set id: 6a6f5da8-6433-4284-8df7-2d5b099b74dc

Reported adverse events (FAERS/openFDA)#

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