DIPHENHYDRAMINE HCL- diphenhydramine hcl capsule, liquid filled 
Softech Pharma Pvt. Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Diphenhydramine HCl 25 mg

Drug Facts

Active Ingredient in each Softgel

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Keep out of reach of Children

Uses

Warnings

Do not use

Directions

Take only one dose per day (24 hours) - see Overdose warning

adults & children 12 yrs & over One dose = Two 25 mg Softgels (50 mg) at bedtime if needed or as directed by a doctor

Other Information

Inactive Ingredients

FD&C blue#1, FD&C red#40, gelatin, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sorbitol, titanium dioxide

Principal Display Panel

Diphenhydramine Hydrochloride Capsules, USP 25 mg

bag-label

DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48769-060
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorpurpleScoreno score
ShapecapsuleSize7mm
FlavorImprint Code R60
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48769-060-995000 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33801/01/2013
Labeler - Softech Pharma Pvt. Ltd (677111277)
Establishment
NameAddressID/FEIBusiness Operations
Softech Pharma Pvt. Ltd677111277manufacture(48769-060)

Revised: 12/2012
Document Id: 5490aefc-7dcf-4bc5-a359-bf34907a0486
Set id: 3e45d7ea-2a97-422a-b73a-c48bc2d1dea5
Version: 1
Effective Time: 20121213
 
Softech Pharma Pvt. Ltd