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

MUCUS RELIEF DM 
guaifenesin, dextromethorphan hbr tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6233(NDC: 49483-280)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score	no score
Shape	ROUND	Size	16mm
Flavor		Imprint Code	TCL280
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6233-46	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/23/2012	02/29/2020
2	NDC: 0904-6233-52	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/23/2012	02/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/23/2012	02/29/2020

Labeler - MAJOR PHARMACEUTICALS INC (191427277)

Registrant - TIME CAP LABORATORIES, INC (037052099)

Revised: 10/2019

Document Id: 01e42400-14bd-4f5d-a423-8a01d9b1105c

34390-5

Set id: 21b737a4-a5ae-4561-88a0-3259cf0953a5

Version: 2

Effective Time: 20191007

 

MAJOR PHARMACEUTICALS INC