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MUCUS RELIEF DM by MAJOR PHARMACEUTICALS INC

Medically reviewed on Jul 23, 2018

Dosage form: tablet
Ingredients: GUAIFENESIN 400mg, DEXTROMETHORPHAN HYDROBROMIDE 20mg
Labeler: MAJOR PHARMACEUTICALS INC
NDC Code: 0904-6233

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.

:  Each immediate-release tablet contains

  Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Expectorant – Cough Suppressant

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

Helps loosen phlegm (mucus)

Helps thin bronchial secretions to make coughs more productive

Temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold

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.

:  Directions:  Adults and children 12 years of age and older, take 1 tablet every 4 hours with a full glass of water while symptoms persist.  Do not exceed 6 doses in 24 hours.

Children under 12 years of age do not use.

Colloidal Silicon Dioxide, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid

Enter section text here

MUCUS RELIEF DM  
guaifenesin, dextromethorphan hbr tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6233(NDC:49483-280)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN ) GUAIFENESIN400 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN ) DEXTROMETHORPHAN 20 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize16mm
FlavorImprint CodeTCL280
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-6233-4630 TABLET (TABLET) in 1 BOTTLE, PLASTIC
2NDC:0904-6233-5260 TABLET (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/23/2012
Labeler - MAJOR PHARMACEUTICALS INC (191427277)
Registrant - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIOperations
TIME CAP LABORATORIES, INC.037052099manufacture(0904-6233)

 
MAJOR PHARMACEUTICALS INC

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Further information

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

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