DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule 
Lake Erie Medical DBA Quality Care Products 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: Qualitest Pharmaceuticals, Inc.

Image of Label

Image of Label

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49999-003(NDC:0603-3339)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
BUTYLPARABEN 
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
LACTOSE 
MAGNESIUM STEARATE 
METHYLPARABEN 
POLYSORBATE 80 
PROPYLPARABEN 
SODIUM LAURYL SULFATE 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code AP;020
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49999-003-2020 in 1 BOTTLE
2NDC:49999-003-2121 in 1 BOTTLE
3NDC:49999-003-2424 in 1 BOTTLE
4NDC:49999-003-3030 in 1 BOTTLE
5NDC:49999-003-6060 in 1 BOTTLE
6NDC:49999-003-1515 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/24/2007
Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
NameAddressID/FEIBusiness Operations
Lake Erie Medical DBA Quality Care Products LLC831276758repack(49999-003)

Revised: 7/2013
Document Id: 65cfa8ab-d15e-490d-a998-c4edd1a3e2bb
Set id: 338b33a4-d7f8-48f0-aff4-24edfa578e80
Version: 2
Effective Time: 20130731
 
Lake Erie Medical DBA Quality Care Products LLC