ROBITUSSIN COUGH AND CHEST CONGESTION DM MAX- dextromethorphan hydrobromide and guaifenesin liquid 
Richmond Division of Wyeth

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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Robitussin Cough & Chest Congestion DM MAX
(dextromethorphan HBr and guaifenesin)

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH 5 ML TSP)

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

  • shake well before using
  • do not take more than 6 doses 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 over2 teaspoons every 4 hours
children under 12 yearsdo not use

OTHER INFORMATION

  • each teaspoon contains: sodium 5 mg
  • store at 20-25°C (68-77°F)
  • alcohol-free
  • dosage cup provided

INACTIVE INGREDIENTS

anhydrous citric acid, artificial & natural flavors, carboxymethylcellulose sodium, D&C red no. 33, FD&C red no. 40, glycerin, high fructose corn syrup, menthol, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, xanthan gum

QUESTIONS OR COMMENTS?

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

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

See New Dosing Information

Adult

Robitussin Cough & Chest Congestion DM Max

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

NON-DROWSY

RELIEVES:

Cough

Chest Congestion/Mucus

Maximum Strength for MUCUS RELIEF

For Ages 12 & Over

Alcohol-Free

4 FL OZ (118 mL)

Robitussin Knows

Choosing the right product is important. Robitussin has different products for adults and for children.

GREEN Boxes

Ages 12 & Over

RED Boxes

Ages Under 12

Use as directed

DOSAGE CUP INCLUDED

Wyeth Consumer Healthcare Madison, NJ 07940 U.S.A. © 2009 Wyeth

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

PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org

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

Robitussin Cough & Chest Congestion DM Max Packaging
ROBITUSSIN COUGH AND CHEST CONGESTION DM MAX 
dextromethorphan hbr, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0031-8668
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
CARBOXYMETHYLCELLULOSE SODIUM 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
MENTHOL 
CELLULOSE, MICROCRYSTALLINE 
POVIDONES 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM BENZOATE 
SORBITOL 
XANTHAN GUM 
Product Characteristics
ColorRED (thick red opaque liquid) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-8668-131 in 1 CARTON
1118 mL in 1 BOTTLE
2NDC:0031-8668-191 in 1 CARTON
2237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/02/200704/30/2014
Labeler - Richmond Division of Wyeth (829390835)

Revised: 12/2012
Document Id: f84dc460-80d1-4d3e-9ba8-b185ed0fb380
Set id: 221cf9ad-0856-41e6-f783-9b17b4ec1dab
Version: 2
Effective Time: 20121210
 
Richmond Division of Wyeth