Diphenhydramine Hydrochloride Rapid Release Gelcaps 50 mg

Diphenhydramine Hydrochloride by

Drug Labeling and Warnings

Diphenhydramine Hydrochloride by is a Other medication manufactured, distributed, or labeled by Granules India Limited, Granules India limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule 
Granules India Limited

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Diphenhydramine Hydrochloride Rapid Release Gelcaps 50 mg

DIPHENHYDRAMINE HYDROCHLORIDE RAPID RELEASE GELCAPS 50 mg

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC: 62207-795

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SHELLAC (UNII: 46N107B71O)
AMMONIA (UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white (blue gray opaque and light blue opaque hard gelatin shells)	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	G16
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-795-38	37500 in 1 BOX	07/20/2017	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		07/20/2017	07/01/2023

Labeler - Granules India Limited (915000087)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India limited		918609236	manufacture(62207-795)

Revised: 7/2023

Document Id: 01c1da06-dc5e-32c3-e063-6294a90a2a17

53409-9

Set id: 54c1d306-dc2e-2885-e054-00144ff8d46c

Version: 4

Effective Time: 20230731