ROBITUSSIN COUGH AND CHEST CONGESTION DM- dextromethorphan hydrobromide and guaifenesin liquid 
ROBITUSSIN COUGH AND CHEST CONGESTION SUGAR FREE DM- 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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DRUG FACTS

ACTIVE INGREDIENTS (IN EACH 5 ML TSP)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 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
  • 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

Robitussin Cough & Chest Congestion DM

  • each teaspoon contains: sodium 7 mg
  • store at 20-25°C (68-77°F)
  • dosage cup provided

Robitussin Cough & Chest Congestion Sugar Free DM

  • each teaspoon contains: sodium 4 mg
  • store at 20-25°C (68-77°F)
  • alcohol-free
  • dosage cup provided

INACTIVE INGREDIENTS

Robitussin Cough & Chest Congestion DM

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

Robitussin Cough & Chest Congestion Sugar Free DM

acesulfame potassium, artificial & natural flavor, citric acid monohydrate, glycerin, methylparaben, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate

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

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

NON-DROWSY

RELIEVES:

Cough

Chest Congestion/Mucus

NEW IMPROVED TASTE

For Ages 12 & Over

Alcohol-Free

8 FL OZ (237 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 USA © 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 Packaging

See New Dosing Information

Adult

Robitussin Cough & Chest Congestion Sugar Free DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

NON-DROWSY

RELIEVES:

Cough

Chest Congestion/Mucus

Specially Formulated for DIABETICS

For Ages 12 & Over

Alcohol & Sugar-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 Sugar-Free DM Packaging
ROBITUSSIN COUGH AND CHEST CONGESTION DM 
dextromethorphan hydrobromide and guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8685
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
FD&C RED NO. 40 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
MENTHOL 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SUCRALOSE 
Product Characteristics
ColorRED (Clear red liquid) Score    
ShapeSize
FlavorPINEAPPLE (pineapple orange flavor and odor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0031-8685-191 in 1 CARTON
1237 mL in 1 BOTTLE
2NDC:0031-8685-421 in 1 CARTON
2355 mL in 1 BOTTLE
3NDC:0031-8685-151 in 1 CARTON
3118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/09/200603/31/2013
ROBITUSSIN COUGH AND CHEST CONGESTION SUGAR FREE DM 
dextromethorphan hydrobromide and guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8686
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
CITRIC ACID MONOHYDRATE 
GLYCERIN 
METHYLPARABEN 
POVIDONES 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM BENZOATE 
Product Characteristics
ColorYELLOW (Clear, colorless to slightly yellow liquid) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0031-8686-131 in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/16/200609/30/2013
Labeler - Richmond Division of Wyeth (829390835)

Revised: 12/2012
Document Id: 2f9fad00-0024-4161-8bd0-ab7414529a23
Set id: 9e2fbc19-46bd-b683-579b-cdc001f28361
Version: 2
Effective Time: 20121207
 
Richmond Division of Wyeth