DIPHENHYDRAMINE HCL - diphenhydramine hcl tablet 
Contract Pharmacal Corp

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

SPL UNCLASSIFIED

*Compare to Benadryl®

Diphenhydramine 25mg and 50mg

ALLERGY RELIEF

Relieves sneezing, runny nose, itchy, watery eyes & itchy throat

1000 Tablets

DO NOT USE IF EITHER CAPSULE BAND OR IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Drug Facts

Active Ingredient

(in each tablet)

Diphenhydramine HCl 25 mg
Diphenhydramine HCl 50 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold

  • sneezing
  • runny nose
  • itchy, watery eyes
  • itchy throat and nose

Warnings

Do not use

  • with any other product containing diphenhydramine, even on applied on skin.

Ask a doctor before use if you have

  • glaucoma
  • a breathing problem  such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist

before use if you are taking sedatives or tranquilizers.

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

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

25 mg
Directions

adults and children 12 years of age and overtake 25 mg to 50 mg (1 to 2 capsules) every 4 to 6 hours, not to exceed 12 capsules in 24 hours
children 6 to under 12 years of agetake 25 mg (1 capsule) every 4 to 6 hours, not to exceed 6 capsules in 24 hours
children under 6 years of ageconsult a physician

50 mg
Directions

adults and children 12 years of age and overtake 50 mg (1 capsule) every 4 to 6 hours, not to exceed 6 capsules in 24 hours
children under 12 years of ageconsult a physician, the proper dosage strength is not available in this package*

*Do not attempt to break capsule. The proper dosage strength and dosing information for children under 12 years of age is available in the 25 mg package.

Other information

  • store at room temperature, USP
  • contains lactose

Inactive ingredients

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and  Starch.

Manufactured by: CONTRACT PHARMACAL CORP
135 Adams Ave., Hauppauge, NY 11788 USA www.cpc.com

R 02/11

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5fa1d326-figure-01
5fa1d326-figure-02
DIPHENHYDRAMINE HCL 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10267-0836
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
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)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code CPC;836
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10267-0836-1100 in 1 BOTTLE
2NDC:10267-0836-41000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33601/01/2004
DIPHENHYDRAMINE HCL 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10267-0835
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
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)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE, PINKScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code CPC;835
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10267-0835-1100 in 1 BOTTLE
2NDC:10267-0835-41000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33601/01/2004
Labeler - Contract Pharmacal Corp (968334974)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corp968334974MANUFACTURE

Revised: 11/2011
Document Id: 5fa1d326-c82a-4f60-b204-b209e082f862
Set id: e7e8f623-9415-4602-aae3-41d434151ab5
Version: 1
Effective Time: 20111117
 
Contract Pharmacal Corp