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MUCOSA DM by TIME CAP LABORATORIES, INC.

Dosage form: tablet
Ingredients: GUAIFENESIN 400mg, DEXTROMETHORPHAN HYDROBROMIDE 20mg
Labeler: TIME CAP LABORATORIES, INC.
NDC Code: 49483-280

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

MUCOSA DM 
guaifenesin dextromethorphan tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-280
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN ) GUAIFENESIN400 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN ) DEXTROMETHORPHAN HYDROBROMIDE20 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:49483-280-0660 TABLET (TABLET) in 1 BOTTLE, PLASTIC
2NDC:49483-280-00100000 TABLET (TABLET) in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/17/2012
Labeler - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIOperations
TIME CAP LABORATORIES, INC.037052099manufacture

Revised: 04/2012
 
TIME CAP LABORATORIES, INC.

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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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