MUCOSA DM- guaifenesin dextromethorphan tablet
Bryant Ranch Prepack

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.

----------

280R MUCOSA DM

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

HOW SUPPLIED

Product: 63629-4458

NDC: 63629-4458-2 20 TABLET in a BOTTLE

NDC: 63629-4458-1 30 TABLET in a BOTTLE

NDC: 63629-4458-3 18 TABLET in a BOTTLE

Guaifenesin/DM 400/20mg Tablet

MUCOSA DM
guaifenesin dextromethorphan tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63629-4458(NDC:49483-280)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63629-4458-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2013	11/27/2019
2	NDC:63629-4458-3	18 in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2013	11/27/2019
3	NDC:63629-4458-2	20 in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2013	11/27/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	04/17/2012	11/27/2019

Labeler - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(63629-4458) , RELABEL(63629-4458)

Revised: 8/2021

Document Id: b25bfa71-cfa4-480f-a3a8-b3b3000426f1

Set id: 71b67078-e702-4203-9323-70d03f7cc031

Version: 1002

Effective Time: 20210817

Bryant Ranch Prepack