DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule 
Aventura Pharmaceuticals, LLC

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

Drug Facts

.

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

Distributed by: Aventura Pharmaceuticals, LLC

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, USP 25 MG

ANTIHISTAMINE

NDC: 69206-995-01 – 100 COUNT

Container Label

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69206-995(NDC:0603-3339)
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:69206-995-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/14/2015
Labeler - Aventura Pharmaceuticals, LLC (079493910)
Registrant - Aventura Pharmaceuticals, LLC (079493910)
Establishment
NameAddressID/FEIBusiness Operations
Denton Pharma, Inc. DBA Northwind Pharmaceuticals080355546repack(69206-995)

Revised: 1/2020
Document Id: 52da654f-04c2-48dc-a619-29e383166a46
Set id: 35fa2ad9-b9e9-44b5-93d9-3476f6d7c3b6
Version: 5
Effective Time: 20200114
 
Aventura Pharmaceuticals, LLC