DIPHENHYDRAMINE HCL- diphenhydramine hydrochloride capsule 
Preferred Pharmaceuticals, 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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Drug Facts

Active ingredient(in each capsule)

Diphenhydramine HCL 25 mg
Diphenhydramine HCL 50 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


Diphenhydramine HCl Capsules, USP 25mg

Diphenhydramine HCl Capsules, USP 50mg
DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68788-9687(NDC:66424-020)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE 
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code PH014
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-9687-115 in 1 BOTTLE, PLASTIC
2NDC:68788-9687-330 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/27/2013
DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68788-9688(NDC:66424-021)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE 
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code PH013
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-9688-115 in 1 BOTTLE, PLASTIC
2NDC:68788-9688-330 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/27/2010
Labeler - Preferred Pharmaceuticals, Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc.791119022MANUFACTURE(68788-9687, 68788-9688)

Revised: 3/2013
Document Id: 3ac0beba-303d-404e-bfec-0cf8c0e8624d
Set id: 3ac0beba-303d-404e-bfec-0cf8c0e8624d
Version: 1
Effective Time: 20130327
 
Preferred Pharmaceuticals, Inc.