CHILDRENS ROBITUSSIN COUGH AND CHEST CONGESTION DM- dextromethorphan hydrobromide and guaifenesin liquid 
Haleon US Holdings LLC

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Drug Facts

Active ingredients (in each 20 ml)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Purposes

Cough suppressant

Expectorant

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

Warnings

Do not use 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

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 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, ask a health professional before use.

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

Directions

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
agedose

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

each 20 ml contains: sodium 20 mg
store at 20–25°C (68–77°F). Do not refrigerate.

Inactive ingredients

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?

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

Distributed by:
Pfizer, Madison, NJ 07940 USA

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

Children's
Robitussin®

AGES 4 & OVER

Cough & Chest
Congestion
DM

DEXTROMETHORPHAN HBr
(Cough Suppressant)
GUAIFENESIN (Expectorant)

Alcohol-Free

4 FL OZ (118 ml)

Principal Display Panel - 118 ml Bottle Label

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

Children's
Robitussin®

FOR AGES 4 & OVER

Cough & Chest
Congestion
DM

DEXTROMETHORPHAN HBr
(Cough Suppressant)
GUAIFENESIN (Expectorant)

Relieves:

1.
Chest Congestion/Mucus
2.
Cough

Non-Drowsy

BETTER
TASTING!*
Great Grape Taste

grape flavor

4 FL OZ
(118 ml)

Principal Display Panel - 118 ml Bottle Carton
CHILDRENS ROBITUSSIN COUGH AND CHEST CONGESTION DM 
dextromethorphan hydrobromide and guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8702
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorPURPLE (purple) Score    
ShapeSize
FlavorGRAPE (grape) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-8702-131 in 1 CARTON05/12/2020
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01205/12/2020
Labeler - Haleon US Holdings LLC (079944263)
Establishment
NameAddressID/FEIBusiness Operations
Pf Soins De Santé Sri203812479ANALYSIS(0031-8702) , LABEL(0031-8702) , MANUFACTURE(0031-8702) , PACK(0031-8702)

Revised: 2/2024
Document Id: 6755f338-34be-43e4-9cdf-bf2c2348cbbd
Set id: 15950273-14c9-4a0b-bbb4-683048add722
Version: 4
Effective Time: 20240208
 
Haleon US Holdings LLC