ROBITUSSIN COUGH PLUS CHEST CONGESTION DM- dextromethorphan hydrobromide and guaifenesin solution 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

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
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

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, menthol, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, triacetin, 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 - 237 ml Bottle Carton

ADULT
See
New
Dosing

Robitussin®

Cough+Chest
Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)

Controls Cough
Relieves Chest Congestion
Thins & Loosens Mucus

Non-Drowsy

BETTER
TASTING!
Same Effective
Cough Relief*
DM

For Ages 12 & Over
8 FL OZ
(237 ml)

Robitussin C+CC DM 8 fl oz (237 ml)
ROBITUSSIN COUGH PLUS CHEST CONGESTION DM 
dextromethorphan hydrobromide and guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8757
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)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
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)  
TRIACETIN (UNII: XHX3C3X673)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-8757-121 in 1 CARTON06/01/2018
1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2NDC:0031-8757-181 in 1 CARTON06/01/2018
2237 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/01/2018
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
Establishment
NameAddressID/FEIBusiness Operations
PF Consumer Healthcare Canada ULC203812479ANALYSIS(0031-8757) , LABEL(0031-8757) , MANUFACTURE(0031-8757) , PACK(0031-8757)

Revised: 1/2023
Document Id: 76a458d5-fa29-48d4-b99d-97117b1d24c1
Set id: 4908b326-e1da-44ca-8087-7e41a16c27b0
Version: 6
Effective Time: 20230120
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC