FDA.reportPublic FDA data

Robitussin

Manufacturer
Haleon US Holdings LLC
Effective date
2025-11-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:42:56

Label at a glance#

ProductRobitussin Day and Night Maximum Strength Cough DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE
Label structure20 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

Label contents#

Full prescribing information#

Active ingredients (in each 20 mL)– Robitussin Maximum Strength Cough+Chest Congestion DM

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Purposes– Robitussin Maximum Strength Cough+Chest Congestion DM

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Uses– Robitussin Maximum Strength Cough+Chest Congestion DM

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– Robitussin Maximum Strength Cough+Chest Congestion DM

WARNINGS SECTION

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.

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions– Robitussin Maximum Strength Cough+Chest Congestion DM

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

age

dose

adults and children 12 years and over

20 mL every 4 hours

children under 12 years

do not use

Other information– Robitussin Maximum Strength Cough+Chest Congestion DM

SPL UNCLASSIFIED SECTION

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

Inactive ingredients– Robitussin Maximum Strength Cough+Chest Congestion DM

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?– Robitussin Maximum Strength Cough+Chest Congestion DM

OTC - QUESTIONS SECTION

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

Active ingredients (in each 20 mL)– Robitussin Maximum Strength Nighttime Cough DM

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 30 mg

Doxylamine succinate, USP 12.5 mg

Purposes– Robitussin Maximum Strength Nighttime Cough DM

OTC - PURPOSE SECTION

Cough suppressant

Antihistamine

Uses– Robitussin Maximum Strength Nighttime Cough DM

INDICATIONS & USAGE SECTION

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • controls the impulse to cough to help you sleep

Warnings– Robitussin Maximum Strength Nighttime Cough DM

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • to sedate a child or to make a child sleepy
  • 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 before use if you have

OTC - ASK DOCTOR SECTION

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts more than 7 days, comes back, or is accompanied by a fever, rash, or persistent headache.

These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions– Robitussin Maximum Strength Nighttime Cough DM

DOSAGE & ADMINISTRATION SECTION

  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • do not take more than 4 doses in any 24-hour period
  • 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 6 hours

children under 12 years

do not use

Other information– Robitussin Maximum Strength Nighttime Cough DM

SPL UNCLASSIFIED SECTION

  • each 20 mL contains:sodium 14 mg
  • store at 20-25°C (68-77°F)

Inactive ingredients– Robitussin Maximum Strength Nighttime Cough DM

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?– Robitussin Maximum Strength Nighttime Cough DM

OTC - QUESTIONS SECTION

call weekdays from 9 AM to 5 PM EST at 1-800-245-1040

Additional information– Robitussin Maximum Strength Day/Night Value Pack

SPL UNCLASSIFIED SECTION

TAMPER-EVIDENT INNER UNITS:

Do Not Use if Tamper-Evident feature on either bottle cap is broken or missing. See individual inner cartons and bottle labels for specific Tamper-Evident features.

Do not take both products within 6 hours of each other.

STRONG SOOTHING ACTION and fast, powerful cough relief

PARENTS: Learn about teen medicine abuse

www.StopMedicineAbuse.org

Principal Display Panel – Robitussin Maximum Strength Cough+Chest Congestion DM

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, EFFECTIVEcough relief

DMMAX

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

Principal Display Panel – Robitussin Maximum Strength Nighttime Cough DM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ADULT

Robitussin

MAXIMUM STRENGTH

Nighttime Cough DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

  • Controls Cough
  • Relieves Runny Nose & Sneezing

FAST, EFFECTIVE cough relief

DMNIGHTTIME MAX

For Ages 12 & Over

4 FL OZ (118 mL)

Robitussin MS Nighttime Cough DM 4 fl oz
Robitussin MS Nighttime Cough DM 4 fl oz

Principal Display Panel – Robitussin Maximum Strength Day/Night Value Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DAY&NIGHT VALUE PACK

ADULT

Robitussin

MAXIMUM STRENGTH

COUGH+CHEST CONGESTION DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

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

FAST, EFFECTIVEcough relief

DMMAX

For Ages 12 & Over

4 FL OZ (118 mL)

MAXIMUM STRENGTH

Nighttime Cough DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

  • Controls Cough
  • Relieves Runny Nose & Sneezing

FAST, EFFECTIVEcough relief

DMNIGHTTIME MAX

For Ages 12 & Over

4 FL OZ (118 mL)

Robitussin Kit Day Night DM Max 4 oz plus 4 oz
Robitussin Kit Day Night DM Max 4 oz plus 4 oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2056073{1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution) } PackGPCK1
20560731 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution) / 1 nighttime (dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution) PackPSN1
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN1
1115329dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral SolutionPSN1
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD1
1115329dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral SolutionSCD1
20560731 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution) / 1 nighttime (dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution) PackSY1
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY1
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY1
1115329dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral SolutionSY1
1115329dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-2103-01RobitussinDay and Night Maximum Strength Cough DM1 in 1 CARTONKIT11
0031-8718-13RobitussinDay and Night Maximum Strength Cough DM1 in 1 CARTONSOLUTION12.5 mg in 20mL1
0031-8718-13RobitussinDay and Night Maximum Strength Cough DM118 mL in 1 BOTTLESOLUTION118 mL30 mg in 20mL1
0031-8739-12RobitussinDay and Night Maximum Strength Cough DM118 mL in 1 BOTTLESOLUTION118 mL20 mg in 20mL1
0031-8739-12RobitussinDay and Night Maximum Strength Cough DM1 in 1 CARTONSOLUTION400 mg in 20mL1

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
0031-8718-13ML - Milliliter0031-871817cf427c-d526-4213-b309-8d0e9c33ec1912019-02-13
0031-8718-18ML - Milliliter0031-8718bebdbba5-3b06-4073-8d1c-fa1ffe74fd4612019-06-19

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0031-21030031-2103-01
0031-87390031-8739-12
0031-87180031-8718-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 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
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
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB

Source Document#

Source XML

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 · 4 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): 0031-2103-01
ndc (package): 0031-8718-13
ndc (package): 0031-8739-12
ndc (product): 0031-2103
ndc11 (package): 00031871813
ndc11 (package): 00031210301
ndc11 (package): 00031873912
spl id: 430487ce-fbd6-66fc-e063-6294a90a32bf
spl set id: b43d8fbd-1977-4465-aa64-79e7b7f54e09
Robitussin Maximum Strength Nighttime Cough DMDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHaleon US Holdings LLC44feee2f-25bc-48d4-8e13-db1d9daaaa902025-10-30WarningsExact identifier
ndc (package): 0031-8718-13
ndc (product): 0031-8718
ndc11 (package): 00031871813
Robitussin Day and Night Cough Relief DM MaxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLCb3d02c91-8f79-4eb4-a378-1072474c572c2025-10-30WarningsExact identifier
ndc (package): 0031-8739-12
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): 0031-8739-12
ndc (product): 0031-8739
ndc11 (package): 00031873912

Reported adverse events (FAERS/openFDA)#

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