MUCUS RELIEF DM by MAJOR PHARMACEUTICALS INC / TIME CAP LABORATORIES, INC

MUCUS RELIEF DM by

Drug Labeling and Warnings

MUCUS RELIEF DM by is a Otc medication manufactured, distributed, or labeled by MAJOR PHARMACEUTICALS INC, TIME CAP LABORATORIES, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MUCUS RELIEF DM- guaifenesin, dextromethorphan hbr tablet 
MAJOR PHARMACEUTICALS INC

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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:  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

MAJOR280R
MUCUS RELIEF DM 
guaifenesin, dextromethorphan hbr tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0904-6233(NDC: 49483-280)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize16mm
FlavorImprint Code TCL280
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0904-6233-4630 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/23/201202/29/2020
2NDC: 0904-6233-5260 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/23/201202/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/23/201202/29/2020
Labeler - MAJOR PHARMACEUTICALS INC (191427277)
Registrant - TIME CAP LABORATORIES, INC (037052099)

Revised: 10/2019
 
MAJOR PHARMACEUTICALS INC