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Robitussin Maximum Strength Cough Plus Chest Congestion DM

Dosage form: capsule, liquid filled
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 10mg, GUAIFENESIN 200mg
Labeler: Richmond Division of Wyeth
NDC Code: 0031-8719

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.

Robitussin® Maximum Strength Cough+Chest Congestion DM

Drug Facts

Active ingredients (in each liquid-filled capsule)Purposes
Dextromethorphan HBr, USP 10 mgCough suppressant
Guaifenesin, USP 200 mgExpectorant

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 over2 capsules every 4 hours
children under 12 yearsdo 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 - 20 Capsule Carton

NEW!
ADULT

Robitussin®

MAXIMUM
STRENGTH

Cough+Chest Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)

Non-Drowsy

Relieves:

Cough
Mucus

DM
MAX

For Ages 12 & Over

20 LIQUID-FILLED
CAPSULES

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
GELATIN 
LIGHT MINERAL OIL 
POLYETHYLENE GLYCOLS 
POVIDONES 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
SORBITAN 
Product Characteristics
ColorRED (clear red) Scoreno score
ShapeOVAL (oblong) Size16mm
FlavorImprint CodeR
Contains    
Packaging
#Item CodePackage Description
1NDC:0031-8719-105 BLISTER PACK in 1 CARTON
12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
2NDC:0031-8719-2010 BLISTER PACK in 1 CARTON
22 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
3NDC:0031-8719-3115 BLISTER PACK in 1 CARTON
32 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
4NDC:0031-8719-70500 POUCH in 1 BOX
42 CAPSULE, LIQUID FILLED in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/23/2013
Labeler - Richmond Division of Wyeth (829390835)

Revised: 05/2013
 
Richmond Division of Wyeth

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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