FDA.reportPublic FDA data

ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM

Manufacturer
Haleon US Holdings LLC
Effective date
2025-10-30
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:41:37

Label at a glance#

ProductROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure10 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Dosage and administration

do not take more than 6 doses in any 24-hour period 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 do not use

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

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not useif 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 before use if you have

OTC - ASK DOCTOR SECTION

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

OTC - STOP USE SECTION

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24-hour period
  • 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, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, glycerin, liquid glucose, menthol, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, triacetin, 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

Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

PARENTS:Learn about teen medicine abuse

www.StopMedicineAbuse.org

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ADULT
Robitussin

MAXIMUM STRENGTH

Cough+Chest
Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)

  • Controls Cough
  • Relieves Chest Congestion
  • Thins & Loosens Mucus


FAST, EFFECTIVE cough relief

DM
MAX

For Ages 12 & Over

4 FL OZ (118 mL)

Robitussin MS Cough Plus Chest Congestion DM 4 FL OZ
Robitussin MS Cough Plus Chest Congestion DM 4 FL OZ

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN11
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD11
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY11
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY11

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-8739-12ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM118 mL in 1 BOTTLESOLUTION11811
0031-8739-12ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM1 in 1 CARTONSOLUTION111
0031-8739-18ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM237 mL in 1 BOTTLESOLUTION23711
0031-8739-18ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM1 in 1 CARTONSOLUTION111
0031-8739-42ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM1 in 1 CARTONSOLUTION111
0031-8739-42ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM355 mL in 1 BOTTLESOLUTION35511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0031-8739-12ML - Milliliter0031-8739c74cd6a5-e068-49f9-9e21-9def37d91daf12017-07-07
0031-8739-18ML - Milliliter0031-8739bb0238dd-eb2f-4f38-b964-9e4d0d50dbdd12017-05-03
0031-8739-42ML - Milliliter0031-87399a7d2b18-ffa6-4c40-ae58-5a11176deb2c12019-08-06

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0031-87390031-8739-12, 0031-8739-18, 0031-8739-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT
TRIACETINXHX3C3X673IACT
XANTHAN GUMTTV12P4NEEIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102025-03-12full-release2026-06-01 00:57:13

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Robitussin Day and Night Maximum Strength Cough DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLCb43d8fbd-1977-4465-aa64-79e7b7f54e092025-11-07WarningsExact identifier
ndc (package): 0031-8739-12
ndc11 (package): 00031873912
Robitussin Day and Night Cough Relief DM MaxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLCb3d02c91-8f79-4eb4-a378-1072474c572c2025-10-30WarningsExact identifier
ndc (package): 0031-8739-18
ndc (package): 0031-8739-12
ndc11 (package): 00031873918
ndc11 (package): 00031873912
ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCf1d022dd-c2ca-497f-87d5-9ef3e20e8ea72025-10-30WarningsExact identifier
ndc (package): 0031-8739-42
ndc (package): 0031-8739-18
ndc (package): 0031-8739-12
ndc (product): 0031-8739
ndc11 (package): 00031873918
ndc11 (package): 00031873942
ndc11 (package): 00031873912
spl id: 4265eb55-7d39-8ba5-e063-6394a90ad0e5
spl set id: f1d022dd-c2ca-497f-87d5-9ef3e20e8ea7

Reported adverse events (FAERS/openFDA)#

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