GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE- guaifenesin and dextromethorphan hydrobromide tablet

Guaifenesin and Dextromethorphan Hydrobromide by

Drug Labeling and Warnings

Guaifenesin and Dextromethorphan Hydrobromide by is a Otc medication manufactured, distributed, or labeled by InvaTech Pharma Solutions LLC, Elysium Pharmaceuticals Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF THE REACH OF CHILDREN

INDICATIONS & USAGE

cough cold, allergic

DOSAGE & ADMINISTRATION

WARNINGS

KEEP OUT OF THE REACH OF CHILDREN,FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING

INACTIVE INGREDIENT

Colloidal Silicon Di oxide USP/NF, Hypromellose 5 [ Hydroxy propyl methyl cellulose - E5] USP, Hypromellose 15 Hydroxy propyl methylcellulose E-15 USP, Magnesium stearate. USP/NF, Maltodextrin USP/NF, Microcrystalline cellulose (PH-102) USP/NF, Polyethylene glycol 400 USP/NF, Polyvinyl pyrrolidone (PVPK 30) USP, Sodium starch glycolate Type-A USP/NF, Stearic acid powder

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
guaifenesin and dextromethorphan hydrobromide tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57631-013
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POVIDONE K30 (UNII: U725QWY32X)
HYPROMELLOSES (UNII: 3NXW29V3WO)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	ET16
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57631-013-10	26500 in 1 BOX; Type 0: Not a Combination Product	01/13/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/13/2021

Labeler - InvaTech Pharma Solutions LLC (078602180)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceuticals Ltd		915664486	manufacture(57631-013) , analysis(57631-013)