DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule 
Advance Pharmaceutical 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

Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, USP 25 MG

ANTIHISTAMINE

NDC: 17714-020-01 – 100 COUNT

NDC: 17714-020-10 – 1000 COUNT (THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN)

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-020
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;020
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17714-020-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/12/1989
2NDC:17714-020-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/12/1989
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/12/1989
Labeler - Advance Pharmaceutical Inc. (078301063)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIBusiness Operations
Advance Pharmaceutical Inc.078301063manufacture(17714-020)

Revised: 12/2017
Document Id: 60f4322f-5ca5-096a-e053-2a91aa0a64eb
Set id: 4e66c626-607f-4558-ab2e-2dd9a25f7be4
Version: 6
Effective Time: 20171222
 
Advance Pharmaceutical Inc.