Robitussin

Manufacturer
Haleon US Holdings LLC
Effective date
2025-10-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:39:08

Label at a glance#

ProductRobitussin Day and Night Cough Relief Value Pack
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, CHLORPHENIRAMINE MALEATE
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 age dose children under 4 years do not use children 4 to under 6 years 5 mL every 4 hours children 6 to under 12 years 10 mL every 4 hours adults and children 12 years and over 20 mL every 4 hours

Label contents#

Full prescribing information#

Active ingredients (in each 20 mL)– Children’s Robitussin Cough & Chest Congestion DM

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 20 mg

Guaifenesin 200 mg

Purposes– Children’s Robitussin Cough & Chest Congestion DM

OTC - PURPOSE SECTION

Cough Suppressant

Expectorant

Uses– Children’s Robitussin 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– Children’s Robitussin 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– Children’s Robitussin 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

age

dose

children under 4 years

do not use

children 4 to under 6 years

5 mL every 4 hours

children 6 to under 12 years

10 mL every 4 hours

adults and children 12 years and over

20 mL every 4 hours

Other information– Children’s Robitussin 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– Children’s Robitussin 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, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum

Questions or comments?– Children’s Robitussin 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 10 mL)– Children’s Robitussin Nighttime Cough Long-Acting DM

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 15 mg

Purposes –Children’s Robitussin Nighttime Cough Long-Acting DM

OTC - PURPOSE SECTION

Antihistamine

Cough suppressant

Uses –Children’s Robitussin Nighttime Cough Long-Acting 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

Warnings– Children’s Robitussin Nighttime Cough Long-Acting 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 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 –Children’s Robitussin Nighttime Cough Long-Acting 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

age

dose

children under 6 years

do not use

children 6 to under 12 years

10 mL every 6 hours

adults and children 12 years and over

20 mL every 6 hours

Other information –Children’s Robitussin Nighttime Cough Long-Acting DM

SPL UNCLASSIFIED SECTION

  • each 10 mL contains:sodium 6 mg
  • store at 20-25°C (68-77°F)

Inactive ingredients –Children’s Robitussin Nighttime Cough Long-Acting DM

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C red no. 40, glycerin, lactic acid, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or comments? –Children’s Robitussin Nighttime Cough Long-Acting DM

OTC - QUESTIONS SECTION

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

Additional Information – Children’s Robitussin Day & Night Cough Relief 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.

Children’s Robitussin liquid is specially formulated to provide soothing action, control your child’s cough – plus relieves other cold symptoms.

PARENTS:Learn about teen medicine abuse

www.StopMedicineAbuse.org

Principal Display Panel – Children’s Robitussin Day & Night Cough Relief Value Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DAY & NIGHT

COUGH RELIEF

VALUE PACK

Children’s Robitussin

AGES 4 & OVER

Cough & Chest Congestion DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

GUAIFENESIN

(Expectorant)

Relieves:

  • Chest Congestion/Mucus
  • Cough

grapeflavor

4 FL OZ (118 mL)

AGES 6 & OVER

Nighttime Cough Long-Acting DM

CHLORPHENIRAMINE MALEATE

(Antihistamine)

DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves:

  • Cough Up to 8 Hours
  • Runny Nose

Alcohol-free

fruit punchflavor

4 FL OZ (118 mL)

Day Night Robitussin Childrens Cough Combo Kit
Day Night Robitussin Childrens Cough Combo Kit

Principal Display Panel – Children’s Robitussin Cough & Chest Congestion DM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children’s

Robitussin

FOR AGES 4 & OVER

Cough & Chest Congestion DM

DEXTROMETHORPHAN HBr
(Cough Suppressant)

GUAIFENESIN
(Expectorant)

Relieves:

  • Chest Congestion/Mucus
  • Cough

BETTER TASTING!*

Great Grape Taste

grapeflavor

4 FL OZ (118 mL)

Childrens Robitussin Cough Chest Congestion DM 4 FL OZ
Childrens Robitussin Cough Chest Congestion DM 4 FL OZ

Principal Display Panel – Children’s Robitussin Nighttim e Cough DM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children’s

Robitussin

AGES 6 & OVER

Nighttime Cough DM

Long-Acting

CHLORPHENIRAMINE MALEATE
(Antihistamine)

DEXTROMETHORPHAN HBr
(Cough Suppressant)

Relieves:

  • Cough Up to 8 Hours
  • Runny Nose

Alcohol-Free

fruit punchflavor

4 FL OZ (118 mL)

Childrens Robitussin Nighttime Cough DM 4 FL OZ
Childrens Robitussin Nighttime Cough DM 4 FL OZ

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2362250{1 (chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral Solution) } PackGPCK1
23622501 daytime (dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 20 mL Oral Solution) / 1 nighttime (chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG in 10 mL Oral Solution) PackPSN1
1111440chlorpheniramine maleate 1 MG / dextromethorphan HBr 7.5 MG in 5 mL Oral SolutionPSN1
1790650dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral SolutionPSN1
1111440chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral SolutionSCD1
1790650dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral SolutionSCD1
23622501 daytime (dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral Solution) / 1 nighttime (chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral Solution) PackSY1
1111440chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 7.5 MG per 5 ML Oral SolutionSY1
1111440chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral SolutionSY1
1790650dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral SolutionSY1
1790650dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral SolutionSY1
1790650dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN 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
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
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
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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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
0031-2099-01RobitussinDay and Night Cough Relief Value Pack1 in 1 CARTONKIT11
0031-8692-13RobitussinDay and Night Cough Relief Value Pack118 mL in 1 BOTTLESOLUTION118 mL15 mg in 10mL1
0031-8692-13RobitussinDay and Night Cough Relief Value Pack1 in 1 CARTONSOLUTION2 mg in 10mL1
0031-8702-13RobitussinDay and Night Cough Relief Value Pack118 mL in 1 BOTTLELIQUID118 mL200 mg in 20mL1
0031-8702-13RobitussinDay and Night Cough Relief Value Pack1 in 1 CARTONLIQUID20 mg in 20mL1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0031-8692-13ML - Milliliter0031-86921a8ba2cf-a8a1-4906-8aeb-9c0d982f096b12019-06-19

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0031-20990031-2099-01
0031-87020031-8702-13
0031-86920031-8692-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

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 Day and Night Cough Relief Value PackDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, CHLORPHENIRAMINE MALEATEHaleon US Holdings LLC4029eccd-5443-4ae2-9232-2a1d922798f82025-10-15WarningsExact identifier
ndc (package): 0031-8692-13
ndc (package): 0031-2099-01
ndc (package): 0031-8702-13
ndc (product): 0031-2099
ndc11 (package): 00031209901
ndc11 (package): 00031869213
ndc11 (package): 00031870213
spl id: 413911db-b452-6adf-e063-6394a90ac22b
spl set id: 4029eccd-5443-4ae2-9232-2a1d922798f8
Childrens Robitussin Nighttime Cough Long-Acting DMCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC8a8380f4-fa8a-4cca-8b8f-f8d7c5a33f9c2024-03-17WarningsExact identifier
ndc (package): 0031-8692-13
ndc (product): 0031-8692
ndc11 (package): 00031869213
Childrens Robitussin Cough and Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINHaleon US Holdings LLC15950273-14c9-4a0b-bbb4-683048add7222024-02-08WarningsExact identifier
ndc (package): 0031-8702-13
ndc (product): 0031-8702
ndc11 (package): 00031870213

Reported adverse events (FAERS/openFDA)#

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