ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM- dextromethorphan hydrobromide and guaifenesin capsule, liquid filled 
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.

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Drug Facts

Active ingredients (in each liquid-filled capsule)

Dextromethorphan HBr, USP 10 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 12 capsules in any 24-hour period
this adult product is not intended for use in children under 12 years of age
agedose

adults and children 12 years and over

2 capsules every 4 hours

children under 12 years

do not use

Other information

store at 20-25°C (68-77°F).
avoid excessive heat above 40°C (104°F).

Inactive ingredients

FD&C Red No. 40, gelatin, glycerin, light mineral oil, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

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

Made in Canada

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

Distributed by: Pfizer, Madison, NJ 07940 USA

PRINCIPAL DISPLAY PANEL

ADULT

Robitussin®

MAXIMUM
STRENGTH

Cough+Chest
Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)

DM
MAX

Relieves:

Cough
Mucus

Non-Drowsy

For Ages 12 & Over

20
LIQUID-FILLED
CAPSULES

PRINCIPAL DISPLAY PANEL - 20 Capsule Blister Pack Carton
ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM 
dextromethorphan hydrobromide and guaifenesin capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8719
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorRED (clear red) Scoreno score
ShapeOVAL (oblong) Size16mm
FlavorImprint Code R
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-8719-105 in 1 CARTON05/02/2016
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0031-8719-2010 in 1 CARTON05/23/2013
22 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0031-8719-3115 in 1 CARTON05/23/201312/31/2018
32 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:0031-8719-70500 in 1 BOX05/23/201312/31/2018
42 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/23/2013
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 1/2022
Document Id: 07a996c0-1cb6-477f-ac53-06bf70ac6f86
Set id: 868ac65a-63e2-46ac-b87d-66b289086756
Version: 8
Effective Time: 20220106
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC