FDA.reportPublic FDA data

CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING

Manufacturer
Haleon US Holdings LLC
Effective date
2025-06-04
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:02:19

Label at a glance#

ProductCHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING
Active ingredientCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections

Indications and uses

• 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

Dosage and administration

• 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 older 20 mL every 6 hours

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 15 mg

Purposes

OTC - PURPOSE SECTION

Antihistamine

Cough suppressant

Uses

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

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are 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

OTC - STOP USE SECTION

Stop use and ask a doctor if 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.

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

  • 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
agedose

children under 6 years

do not use

children 6 to under 12 years

10 mL every 6 hours

adults and children 12 years and older

20 mL every 6 hours

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

Additional Information

SPL UNCLASSIFIED SECTION

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

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

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Use dosage cup included

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children's

Robitussin

AGES 6 & OVER

Cough & Cold

Long-Acting

CHLORPHENIRAMINE MALEATE (Antihistamine)
DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves:

  • Cough Up to 8 Hours
  • Runny Nose

Alcohol-Free

fruit
punch
flavor

4 FL OZ
(118 ml)

Childrens Robitussin Cough and Cold Long-Acting 4 FL OZ
Childrens Robitussin Cough and Cold Long-Acting 4 FL OZ

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1111440chlorpheniramine maleate 1 MG / dextromethorphan HBr 7.5 MG in 5 mL Oral SolutionPSN6
1111440chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral SolutionSCD6
1111440chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 7.5 MG per 5 ML Oral SolutionSY6
1111440chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral SolutionSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0031-8693-122024-01-30C16284748780-11030e365-4686-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-8693-12CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING1 in 1 CARTONLIQUID16
0031-8693-12CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING118 mL in 1 BOTTLELIQUID1186

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0031-8693-12ML - Milliliter0031-86933302060a-7976-4ecc-a629-d69e9fa62c1c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
chlorpheniramine maleateACTIVE INGREDIENTV1Q0O9OJ9Z1
dextromethorphan hydrobromideACTIVE INGREDIENT9D2RTI9KYH1
chlorpheniramineACTIVE MOIETY3U6IO1965U1
dextromethorphanACTIVE MOIETY7355X3ROTS1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0031-86930031-8693-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT

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
CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTINGCHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBRHaleon US Holdings LLCbecb4025-b63e-f2ea-9d11-d51fdf4e5c132025-06-04WarningsExact identifier
ndc (package): 0031-8693-12
ndc (product): 0031-8693
ndc11 (package): 00031869312
spl id: 1511b29b-fd49-44fd-aff1-89809fb6c971
spl set id: becb4025-b63e-f2ea-9d11-d51fdf4e5c13

Reported adverse events (FAERS/openFDA)#

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