Diphenhydramine Hydrochloride Rapid Release Gelcaps 25 mg

Diphenhydramine Hydrochloride by

Drug Labeling and Warnings

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

Drug Details [pdf]

DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule 
Granules India Limited

----------

Diphenhydramine Hydrochloride Rapid Release Gelcaps 25 mg

Diphenhydramine Hydrochloride Rapid Release Gelcaps 25 mg

shipper-label

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC: 62207-789
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
AMMONIA (UNII: 5138Q19F1X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
SHELLAC (UNII: 46N107B71O)  
TALC (UNII: 7SEV7J4R1U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorgray (blue gray opaque and purple opaque hard gelatin shells) Scoreno score
ShapeCAPSULESize16mm
FlavorImprint Code G15
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62207-789-3837500 in 1 BOX07/20/2017
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only07/20/2017
Labeler - Granules India Limited (915000087)

Revised: 12/2019
Document Id: 98ee9974-4911-2be7-e053-2995a90aea15
Set id: 54c1d306-dc2c-2885-e054-00144ff8d46c
Version: 4
Effective Time: 20191204
 
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.