ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE tablet

Acetaminophen and Diphenhydramine citrate by

Drug Labeling and Warnings

Acetaminophen and Diphenhydramine citrate by is a Otc medication manufactured, distributed, or labeled by InvaTech Pharma Solutions LLC, Elysium Pharmaceutical Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF THE REACH OF CHILDREN

INDICATIONS & USAGE

Analgesic and Antipyretic 

DOSAGE & ADMINISTRATION

FOR MANUFACTURING, PROCESSING OR REPACKING

WARNINGS

KEEP OUT OF THE REACH OF CHILDREN,REMOVE SILICA GEL BAG BEFORE USE

INACTIVE INGREDIENT

Microcrystalline Cellulose, Polyethylene glycol, Polyvinyl pyrrolidinone, Pregelatinized Starch, Starch, Stearic Acid powder, colloidal Silicon Dioxide, talc, Hypromellose

PURPOSE

FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE 
acetaminophen and diphenhydramine citrate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57631-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE CITRATE	38 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	S26
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57631-010-00	30000 in 1 BOX; Type 0: Not a Combination Product	10/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	10/01/2025

Labeler - InvaTech Pharma Solutions LLC (078602180)

Registrant - Elysium Pharmaceutical Ltd (915664486)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceutical Ltd		915664486	analysis(57631-010) , manufacture(57631-010)