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Robi DM Max Cough Congestion 10ct Blister

Medically reviewed on October 14, 2016

Dosage form: capsule, gelatin coated
Ingredients: GUAIFENESIN 200mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg
Labeler: Accucaps Industries Limited
NDC Code: 61474-8135

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.

Robi DM Max Cough Congestion 10ct Blister

ACTIVE INGREDIENT

Active ingredients (in each liquid-filled capsule)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 200 mg

PURPOSE

Purpose

Cough suppressant

Expectorant

USES

Uses

  • temporarily relieves cough due to throat and bronchial irriatation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

WARNINGS

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 bronchitisi, 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 of breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

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

DOSAGE

adults and children 12 years and over - capsules every 4 hours

children under 12 years - do not use

INACTIVE INGREDIENTS

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL - 24 Capsule Carton

Robitussin®

MAXIMUM STRENGTH

Cough+Cheat Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

DM MAX

Relieves:

Cough

Mucus

Non-Drowsy

For Ages 12 & Over

10 LIQUID-FILLED CAPSULES

ROBI DM MAX COUGH CONGESTION  10CT BLISTER
guaifenesin and dextromethorphan hydrobromide capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61474-8135
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
POVIDONE K12 
Gelatin 
Glycerin 
SORBITOL 
SORBITAN 
MANNITOL 
Water 
FD&C RED NO. 40 
TITANIUM DIOXIDE 
Shellac 
Dimethicone 
Silicon Dioxide 
Product Characteristics
ColorredScoreno score
ShapeCAPSULESize16mm
FlavorImprint CodeR
Contains    
Packaging
#Item CodePackage Description
1NDC:61474-8135-11 BLISTER PACK in 1 CARTON
110 CAPSULE, GELATIN COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/29/2013
Labeler - Accucaps Industries Limited (248441727)
Establishment
NameAddressID/FEIOperations
Accucaps Industries Limited248441727MANUFACTURE(61474-8135), ANALYSIS(61474-8135)
Establishment
NameAddressID/FEIOperations
Accucaps Industries Limited243944050PACK(61474-8135), label(61474-8135), analysis(61474-8135), manufacture(61474-8135)

 
Accucaps Industries Limited

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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