MUCOSA DM- guaifenesin dextromethorphan tablet

MUCOSA DM by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Each immediate-release tablet contains

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

PURPOSE

Expectorant – Cough Suppressant

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

INDICATIONS & USAGE

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

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.

DOSAGE & ADMINISTRATION

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.

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

MUCOSA DM 
guaifenesin dextromethorphan tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	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)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (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: 49483-280-06	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/17/2018
2	NDC: 49483-280-00	100000 in 1 CARTON; Type 0: Not a Combination Product	12/17/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/17/2012

Labeler - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC.		037052099	manufacture(49483-280)