DIPHENHYDRAMINE HYDROCHLORIDE 25- diphenhydramine hydrochloride 25 capsule

Diphenhydramine Hydrochloride 25 by

Drug Labeling and Warnings

Diphenhydramine Hydrochloride 25 by is a Otc medication manufactured, distributed, or labeled by Elysium Pharmaceuticals Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

diphenydramine HCL 25mg 

PURPOSE

antihistaminc and for further packing and labelling 

KEEP OUT OF REACH OF CHILDREN

keep out of reach children 

WARNINGS

for further packing and labelling 

INACTIVE INGREDIENT

Allura Red AC IH, Brilliant blue FCF IH, Gelatin 160 BLOOM USP/NF, Glycerin USP, Polyethylene Glycol 400 - India glycols USP/NF,,Purified water, Sorbitol solution 70% Non crystalline,Medium chain triglycerides,white ink.

INDICATIONS & USAGE

antihstaminc and for further final packing 

DOSAGE & ADMINISTRATION

antihsitaminc and for further packing 

PRINCIPAL DISPLAY PANEL

bulk label

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 25 
diphenhydramine hydrochloride 25 capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14803-912
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Product Characteristics
Color	purple	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	912
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14803-912-00	72000 in 1 DRUM; Type 0: Not a Combination Product	11/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/01/2025

Labeler - Elysium Pharmaceuticals Limited (915664486)

Registrant - Elysium Pharmaceuticals Limited (915664486)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceuticals Limited		915664486	manufacture(14803-912) , analysis(14803-912)