DIPHENHYDRAMINE HYDROCHLORIDE - diphenhydramine hydrochloride capsule 
DOH CENTRAL PHARMACY

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 HYDROCHLORIDE CAPSULES, USP 25mg

Active Ingredient

(in each capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

Warnings

Do not use with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other Information

Inactive Ingredients

benzyl alcohol, butylparaben, D&C red# 28, edible black ink, FD&C bule #1, FD&C red# 40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium laurel sulfate

PACKAGE LABEL

Label Image for 53808-1106
25mg

Label Image for 25mg
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53808-1106(NDC:54738-115)
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
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code AP;20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53808-1106-130 in 1 BLISTER PACK; Type 0: Not a Combination Product08/13/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/13/2018
Labeler - DOH CENTRAL PHARMACY (829348114)
Establishment
NameAddressID/FEIBusiness Operations
DOH CENTRAL PHARMACY829348114repack(53808-1106)

Revised: 1/2019
Document Id: 9dac4ba1-0d9e-4c3a-8cde-03cf82072e7f
Set id: 94bfe2eb-e860-4cb3-a733-dcabc1305fea
Version: 1
Effective Time: 20190122
 
DOH CENTRAL PHARMACY