DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule 
Epic Pharma, 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.

----------

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, USP 25 mg

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

​Ask a doctor or pharmacist before use if you are​ taking sedatives or tranqulizers

​When using this product

​If pregnant or breast-feeding​, ask a health professional before use.

KEEP OUT OF THE REACH OF CHILDREN.

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

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

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

QUESTIONS OR COMMENTS?

call ​888-374-2791, 8:30 am - 4:30 pm ET, Monday - Friday

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

​Distributed by:

Epic Pharma, LLC

Laurelton, NY

11413

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 25 MG

​Diphenhydramine HCl Capsules, USP​25 mg

​ANTIHISTAMINE

​1000 Capsules

​THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

diphenhydramine-25mg-1000s

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42806-648
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:42806-648-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/22/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/22/2016
Labeler - Epic Pharma, LLC (827915443)

Revised: 11/2016
Document Id: 92732b8c-9804-4019-bd6c-5cc5077b1b0e
Set id: a083dec1-d4a7-4573-8a14-f5739d5bf153
Version: 1
Effective Time: 20161122
 
Epic Pharma, LLC