DIPHENHYDRAMINE HCL- diphenhydramine hcl capsule 
Blenheim Pharmacal, 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

Purpose

Antihistamine

Uses:

Warnings:


Do not use

Ask a doctor or pharmacist before use

If you have:

If you are taking sedatives or tranquilizers

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


Principal Display Panel

Blenheim Pharmacal, Inc.

NDC 10544-166-15

Diphenhydramine HCl Capsules, USP 25mg

15 Capsules

25mg 15ct

DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10544-166(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:10544-166-1515 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/12/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/12/2010
Labeler - Blenheim Pharmacal, Inc. (171434587)
Registrant - Blenheim Pharmacal, Inc. (171434587)
Establishment
NameAddressID/FEIBusiness Operations
Blenheim Pharmacal, Inc.171434587repack(10544-166)

Revised: 3/2015
Document Id: 11a88159-9fdc-1983-e054-00144ff8d46c
Set id: 117fead9-699d-57ae-e054-00144ff88e88
Version: 2
Effective Time: 20150317
 
Blenheim Pharmacal, Inc.