FDA.reportPublic FDA data

Robitussin

Manufacturer
Haleon US Holdings LLC
Effective date
2025-11-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:42:29

Label at a glance#

ProductRobitussin Honey Cough DM Day Night Value Pack
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 Honey Maximum Strength Cough + Chest Congestion DM

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Purposes– Robitussin Honey Maximum Strength Cough + Chest Congestion DM

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Uses– Robitussin Honey 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 Honey Maximum Strength Cough + Chest Congestion DM

WARNINGS SECTION

Click here to enter Warnings

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 MOAI 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 Honey 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 Honey Maximum Strength Cough + Chest Congestion DM

SPL UNCLASSIFIED SECTION

  • each 20 mL contains:sodium 21 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients– Robitussin Honey Maximum Strength Cough + Chest Congestion DM

INACTIVE INGREDIENT SECTION

anhydrous citric acid, carboxymethylcellulose sodium, glycerin, natural and artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate

Questions or comments?– Robitussin Honey 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 Honey Maximum Strength Nighttime Cough DM

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purposes– Robitussin Honey Maximum Strength Nighttime Cough DM

OTC - PURPOSE SECTION

Cough suppressant

Antihistamine

Uses– Robitussin Honey 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 Honey Maximum Strength Nighttime Cough DM

WARNINGS SECTION

Click here to enter Warnings

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 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 Honey 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 Honey Maximum Strength Nighttime Cough DM

SPL UNCLASSIFIED SECTION

  • each 20 mL contains:sodium 21 mg
  • store at 20-25°C (68-77°F).

Inactive ingredients– Robitussin Honey Maximum Strength Nighttime Cough DM

INACTIVE INGREDIENT SECTION

anhydrous citric acid, blueberry juice concentrate, carboxymethylcellulose sodium, glycerin, lactic acid, natural and artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate

Questions or comments?– Robitussin Honey Maximum Strength Nighttime Cough DM

OTC - QUESTIONS SECTION

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

Additional Information – Robitussin Honey DM Day Night Value Pack

SPL UNCLASSIFIED SECTION

Packaged with Tamper-Evident bottle cap.

Do Not Use if breakable ring is separated or missing.

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

ADULT

Robitussin

Honey

This dynamic duo combines the great taste of natural honey you want with the powerful, effective cough relief you need.

Made with RealHONEY

TRUE SOURCE CERTIFIED HONEY

Gluten Free

No Artificial Colors

PARENTS:Learn about teen medicine abuse

www.StopMedicineAbuse.org

Principal Display Panel – Robitussin Honey DM Day Night Value Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DAY NIGHT VALUE PACK

ADULT

Robitussin

Honey

Cough+Chest Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

MAXIMUM STRENGTH

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

Taste the Real Honey

DMMAX

For Ages 12+

4 FL OZ (118 mL)

ADULT

Robitussin

Honey

Nighttime Cough DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

MAXIMUM STRENGTH

  • Controls Cough
  • Relieves runny nose and sneezing

Taste the Real Honey

DMNIGHTTIME MAX

For Ages 12+

4 FL OZ (118 mL)

Robitussin Honey Day Night Value Pack DM 4 oz 4 oz
Robitussin Honey Day Night Value Pack DM 4 oz 4 oz

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ADULT

Robitussin

Honey

Cough+Chest Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

MAXIMUM STRENGTH

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

Taste the Real Honey

DMMAX

For Ages 12+

4 FL OZ (118 mL)

Robitussin Honey Cough Chest Congestion DM 4 FL oz
Robitussin Honey Cough Chest Congestion DM 4 FL oz

Principal Display Panel – Robitussin Honey Maximum Strength Nighttime Cough DM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ADULT

Robitussin

Honey

Nighttime Cough DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

MAXIMUM STRENGTH

  • Controls Cough
  • Relieves runny nose and sneezing

Taste the Real Honey

DMNIGHTTIME MAX

For Ages 12+

4 FL OZ (118 mL)

Robitussin Honey Nighttime Cough DM 4 FL oz
Robitussin Honey Nighttime Cough DM 4 FL 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
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-2059-01RobitussinHoney Cough DM Day Night Value Pack1 in 1 CARTONKIT11
0031-8756-12RobitussinHoney Cough DM Day Night Value Pack1 in 1 CARTONSOLUTION400 mg in 20mL1
0031-8756-12RobitussinHoney Cough DM Day Night Value Pack118 mL in 1 BOTTLESOLUTION118 mL20 mg in 20mL1
0031-8758-12RobitussinHoney Cough DM Day Night Value Pack118 mL in 1 BOTTLESOLUTION118 mL12.5 mg in 20mL1
0031-8758-12RobitussinHoney Cough DM Day Night Value Pack1 in 1 CARTONSOLUTION30 mg in 20mL1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0031-8756-12ML - Milliliter0031-87568416ba12-afa1-4752-97ab-31d20f644e5f12019-07-02
0031-8756-18ML - Milliliter0031-8756913071af-382f-4fe6-ad2d-df68bbb113a912019-08-06
0031-8758-12ML - Milliliter0031-8758f347b7e8-eefe-40b3-a382-be63c1019bcd12019-08-06
0031-8758-18ML - Milliliter0031-87583a65a26a-eed3-49ee-9ae9-5ccf8887a83712022-06-06

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0031-20590031-2059-01
0031-87560031-8756-12
0031-87580031-8758-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
GLYCERINPDC6A3C0OXIACT
HONEYY9H1V576FHIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM GLUCONATER6Q3791S76IACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
ZINC GLUCONATEU6WSN5SQ1ZIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
GLYCERINPDC6A3C0OXIACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT
HONEYY9H1V576FHIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM GLUCONATER6Q3791S76IACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
ZINC GLUCONATEU6WSN5SQ1ZIACT
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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Robitussin Honey Cough DM Day Night Value PackDEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLC1bbd0157-06e6-4a3b-bac9-91ac879ba0892025-11-06WarningsExact identifier
ndc (package): 0031-2059-01
ndc (package): 0031-8758-12
ndc (package): 0031-8756-12
ndc (product): 0031-2059
ndc11 (package): 00031205901
ndc11 (package): 00031875612
ndc11 (package): 00031875812
spl id: 42f4c947-69fb-0aed-e063-6394a90a545d
spl set id: 1bbd0157-06e6-4a3b-bac9-91ac879ba089
Robitussin Honey Maximum Strength Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCeaa10aed-5b1e-48bf-bc05-7a5638851daf2024-05-03WarningsExact identifier
ndc (package): 0031-8756-12
ndc (product): 0031-8756
ndc11 (package): 00031875612
Robitussin Honey Maximum Strength Nighttime Cough DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHaleon US Holdings LLC0b41da13-18a1-4987-ae43-1319bfa274842024-05-01WarningsExact identifier
ndc (package): 0031-8758-12
ndc (product): 0031-8758
ndc11 (package): 00031875812

Reported adverse events (FAERS/openFDA)#

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