Childrens Robitussin Cough Long-Acting

Manufacturer: Haleon US Holdings LLC
Effective date: 2024-03-17
Label type: HUMAN OTC DRUG LABEL
Version: 10
Source: full-release
Hydrated at: 2026-06-01 00:09:54

Label at a glance#

ProductChildrens Robitussin Cough Long-Acting

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE

Label structure9 sections

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 4 years do not use children 4 to under 6 years 5 ml every 6 - 8 hours children 6 to under 12 years 10 ml every 6 to 8 hours adults and children 12 years and older 20 ml every 6 to 8 hours

Storage and handling

each 10 ml contains: sodium 11 mg store at 20-25°C (68-77°F)

Contacts and useful links#

PhoneLabel contact1-800-762-4675

Websitewww.robitussin.com

www.robitussin.com

Label contents#

Full prescribing information#

Active ingredient (in each 10 ml)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 15 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Use

INDICATIONS & USAGE SECTION

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

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 4 years	do not use
children 4 to under 6 years	5 ml every 6 - 8 hours
children 6 to under 12 years	10 ml every 6 to 8 hours
adults and children 12 years and older	20 ml every 6 to 8 hours

Other information

STORAGE AND HANDLING SECTION

each 10 ml contains:sodium 11 mg
store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, artificial flavor, FD&C red no. 40, glycerin, high fructose corn syrup, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate

Questions or comments?

OTC - QUESTIONS SECTION

Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

Distributed by:
Pfizer, Madison, NJ 07940 USA

For most recent product information, visit
www.robitussin.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW
Dosing
Information

Children's
Robitussin ^®
NOW FOR AGES 4 & OVER

Cough

Long-Acting

DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves:

✓ Cough Up to 8 Hours

Alcohol-Free

fruit
punch
flavor

4 FL OZ
(118 ml)

Principal Display Panel - 118 ml Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1370211	dextromethorphan HBr 7.5 MG in 5 mL Oral Solution	PSN	10
1370211	dextromethorphan hydrobromide 1.5 MG/ML Oral Solution	SCD	10
1370211	dextromethorphan hydrobromide 15 MG per 10 ML Oral Solution	SY	10

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEXTROMETHORPHAN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0031-8694-12	Childrens Robitussin Cough Long-Acting	1 in 1 CARTON	LIQUID	1		10
0031-8694-12	Childrens Robitussin Cough Long-Acting	118 mL in 1 BOTTLE	LIQUID	118		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0031-8694	CHILDRENS ROBITUSSIN COUGH LONG-ACTING (DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HALEON US HOLDINGS LLC]	10	Current NDC, Legacy NDC, 2 package rows	20240318_75bc7827-4439-e6a8-a65c-7154d5592e58.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0031-8694-12	ML - Milliliter	0031-8694	d2d8fc96-c53c-40a2-8860-5710da271380	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	4
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	4
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	4
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	4
PROPYLENE GLYCOL, (R)-	INACTIVE INGREDIENT	602HN5L69H	4
SACCHARIN SODIUM DIHYDRATE	INACTIVE INGREDIENT	SB8ZUX40TY	4
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	4
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	4

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Childrens Robitussin Cough Long-Acting
dextromethorphan hydrobromide
ANHYDROUS CITRIC ACID
FD&C RED NO. 40
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
PROPYLENE GLYCOL
WATER
SACCHARIN SODIUM
SODIUM BENZOATE
SODIUM CHLORIDE
SODIUM CITRATE, UNSPECIFIED FORM
DEXTROMETHORPHAN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0031-8694	0031-8694-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GLYCERIN	PDC6A3C0OX	IACT
HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
SODIUM CITRATE, UNSPECIFIED FORM	1Q73Q2JULR	IACT
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 176 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	GRANULE, FOR SUSPENSION / ORAL		30 mg	Exact identifier — unii+route 44 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SUSPENSION / ORAL		98 mg	Exact identifier — unii+route 40 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	DROPS / ORAL	NA		Exact identifier — unii+route 40 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, DELAYED RELEASE / ORAL	0.34 mg		Exact identifier — unii+route 38 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET / ORAL		197 mg	Exact identifier — unii+route 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CONCENTRATE / ORAL		84 mg	Exact identifier — unii+route 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii+route 38 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET / ORAL	30 mg		Exact identifier — unii+route 38 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii+route 44 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SYRUP / ORAL		40 mg	Exact identifier — unii+route 40 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	DROPS / ORAL	NA		Exact identifier — unii+route 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii+route 38 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / SUBCUTANEOUS	0.7 %w/v		Exact identifier — unii+dosage form 40 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SOLUTION / ORAL		98 mg	Exact identifier — unii+route 38 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	POWDER, FOR SOLUTION / ORAL		123 mg	Exact identifier — unii+route 44 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ORAL		1126 mg	Exact identifier — unii+route 40 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii+route 38 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, EFFERVESCENT / ORAL		840 mg	Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii+route 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	LIQUID / INTRAVENOUS		18 mg	Exact identifier — unii+dosage form 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii+route 38 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / NASAL	7.4 mg/1ml		Exact identifier — unii+dosage form 40 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 38 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ORAL		1126 mg	Exact identifier — unii+route 40 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION, EXTENDED RELEASE / ORAL		62 mg	Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii+route 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SOLUTION / ORAL	0.33 mg/5ml		Exact identifier — unii+route 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii+route 38 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	PASTE / ORAL		26 mg	Exact identifier — unii+route 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CONCENTRATE / ORAL		84 mg	Exact identifier — unii+route 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CAPSULE / ORAL		131 mg	Exact identifier — unii+route 44 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET / ORAL		231 mg	Exact identifier — unii+route 40 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii+route 38 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION, EXTENDED RELEASE / ORAL		62 mg	Exact identifier — unii+route 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SUSPENSION / ORAL		160 mg	Exact identifier — unii+route 38 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SUSPENSION / ORAL		160 mg	Exact identifier — unii+route 38 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CAPSULE, LIQUID FILLED / ORAL		360 mg	Exact identifier — unii+route 44 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUP	HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	SOLUTION / ORAL		10000 mg	Exact identifier — unii+route 6 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SYRUP / ORAL		268 mg	Exact identifier — unii+route 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, ORALLY DISINTEGRATING / ORAL		46 mg	Exact identifier — unii+route 44 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET / ORAL		231 mg	Exact identifier — unii+route 40 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SYRUP / ORAL		40 mg	Exact identifier — unii+route 40 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii+route 38 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL		16 mg	Exact identifier — unii+route 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION/ DROPS / ORAL		15 mg	Exact identifier — unii+route 44 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUP	HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	SUSPENSION, EXTENDED RELEASE / ORAL		3000 mg	Exact identifier — unii+route 6 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	ELIXIR / ORAL	5.02 mg/5ml		Exact identifier — unii+route 38 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION/ DROPS / ORAL		1 mg	Exact identifier — unii+route 44 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SOLUTION / ORAL		98 mg	Exact identifier — unii+route 38 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAVENOUS		6320 mg	Exact identifier — unii+dosage form 40 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii+route 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	FILM, SOLUBLE / ORAL		7 mg	Exact identifier — unii+route 44 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / ORAL		148 mg	Exact identifier — unii+route 40 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii+route 38 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SYRUP / ORAL		3 mg	Exact identifier — unii+route 44 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUP	HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	SUSPENSION, EXTENDED RELEASE / ORAL		3000 mg	Exact identifier — unii+route 6 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, FILM COATED / ORAL	2.5 mg		Exact identifier — unii+route 44 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Robitussin Cough Long-Acting	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	75bc7827-4439-e6a8-a65c-7154d5592e58	2024-03-17	Warnings	Exact identifier ndc (package): 0031-8694-12 ndc (product): 0031-8694 ndc11 (package): 00031869412 spl id: 13de389a-3701-8e4c-e063-6294a90a2587 spl set id: 75bc7827-4439-e6a8-a65c-7154d5592e58

Reported adverse events (FAERS/openFDA)#

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