DIPHENHYDRAMINE HCL - diphenhydramine hcl capsule 
Physicians Total Care, 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.

----------

Drug Facts

Active ingredient(in each capsule)

Diphenhydramine HCL 25 mg

Purpose

Antihistamine

Uses:

Warnings:


Do not use

Ask a doctor or pharmacist before use

If you have

When using this product

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children

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

Directions:

Adults and children 12 years or over
1 to 2 capsule                                     
Children 6 to under 12 years
1 capsule
Children under 6 years
ask a doctor

Other information:

Inactive ingredients:


Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate

HOW SUPPLIED

Diphenhydramine HCL 25 mg Capsules

Bottles of 10
NDC 54868-0026-5
Bottles of 20
NDC 54868-0026-6
Bottles of 30
NDC 54868-0026-1
Bottles of 60
NDC 54868-0026-7
Bottles of 90
NDC 54868-0026-8
Bottles of 100
NDC 54868-0026-0
Bottles of 1000
NDC 54868-0026-4


Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146

PRINCIPAL DISPLAY PANEL

Diphenhydramine HCL Capsules

25 mg

image of label

DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-0026(NDC:66424-020)
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
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
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 MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code PH014
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-0026-0100 in 1 BOTTLE, PLASTIC
2NDC:54868-0026-130 in 1 BOTTLE, PLASTIC
3NDC:54868-0026-41000 in 1 BOTTLE, PLASTIC
4NDC:54868-0026-510 in 1 BOTTLE, PLASTIC
5NDC:54868-0026-620 in 1 BOTTLE, PLASTIC
6NDC:54868-0026-760 in 1 BOTTLE, PLASTIC
7NDC:54868-0026-890 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/27/2010
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel, repack

Revised: 6/2012
Document Id: c386e74e-03a0-499f-89c2-5e1b01b5ca52
Set id: 2b9b13b5-b530-4359-b094-1708c7a8e6d5
Version: 1
Effective Time: 20120605
 
Physicians Total Care, Inc.