DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule 
Richmond Pharmaceuticals, Inc.

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

Questions or Comments

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, USP 25 MG -

ANTIHISTAMINE 

NDC:  54738-115-24 

– 24 COUNT

NDC: 54738-115-01– 100 COUNT

IMG_4676

NDC: 54738-115-03– 1000 COUNT(THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN)

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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 (UNII: 2G86QN327L)  
LACTOSE (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:54738-115-2424 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2015
2NDC:54738-115-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2015
3NDC:54738-115-031000 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2015
Labeler - Richmond Pharmaceuticals, Inc. (043569607)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIBusiness Operations
Advance Pharmaceutical Inc.078301063manufacture(54738-115)

Revised: 12/2019
Document Id: 9a63d162-4e53-4f35-e053-2a95a90a4492
Set id: 2792032a-ff0f-4d5f-a8e3-b8b8c54f4e99
Version: 3
Effective Time: 20191223
 
Richmond Pharmaceuticals, Inc.