GUAIFENESIN 400- guaifenesin tablets 400 tablet

Guaifenesin 400 by

Drug Labeling and Warnings

Guaifenesin 400 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

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

cough, cold

DOSAGE & ADMINISTRATION

WARNINGS

INACTIVE INGREDIENT

Calcium sennosides 20% IH, Colloidal Silicon Di oxide USP/NF, Croscarmellose sodium USP/NF, Crospovidone [Kollidon] USP/NF, Dicalcium phosphate/ dibasic calcium phosphate [DIREC] USP/NF, Filmcoat AMB-51D0393632-Blue lake IH, Magnesium stearate. USP/NF, Microcrystalline cellulose (PH-102) USP/NF, Sodium lauryl sulfate USP/NF, Stearic acid powder USP/NF, Purified water

Sennosides Tablets USP, 25 mg Label

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUAIFENESIN 400 
guaifenesin tablets 400 tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57631-012
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
POVIDONE K30 (UNII: U725QWY32X)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	EB
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57631-012-00	28000 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)

Registrant - Elysium Pharmaceuticals Ltd (915664486)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceuticals Ltd		915664486	analysis(57631-012) , manufacture(57631-012)