ALLERGY ANTIHISTAMINE- diphenhydramine hydrochloride capsule 
Valu Merchandisers Company (Best Choice)

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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Active ingredient (in each capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms of the common cold:

  • runny nose
  • sneezing 

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes

Warnings

Do not use

with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis

  • glaucoma

  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

  • excitability may occur, especially in children

  • marked drowsiness may occur

  • avoid alcoholic drinks

  • alcohol, sedatives, and tranquilizers may increase drowsiness

  • be careful when operating machinery or driving a motor vehicle

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

  • take every 4 to 6 hours, not more than 6 doses in 24 hours
adults and children 12 years of age and over take 1 or 2 capsules 
children 6 to under 12 years of age take 1 capsule
children under 6 years of age consult a doctor
children under 4 years of age do not use

Other information

  • store at room temperature 15°- 30°C (59° to 86°F) in a dry place

  • protect from light

  • do not use if red band around capsule is broken or missing

Inactive ingredients

D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch.

Questions or comments?

Call toll free 1-877-753-3935

Principal Display Panel

Compare to the Active Ingredient of Benadryl® ALLERGY KAPGELS®* 

*This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Benadryl® ALLERGY KAPGELS®

Antihistamine

Allergy capsules

Diphenhydramine Hydrochloride 25 mg

For allergy relief of:

  • sneezing
  • itchy, watery eyes
  • Active Ingredient
  • itchy throat

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

Product Label

Valu Merchandisers (Best Choice)

Diphenhydramine HCl 25 mg

ALLERGY  ANTIHISTAMINE
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-970
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
LACTOSE 
STARCH, CORN 
Product Characteristics
ColorPINK, WHITEScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code CPC835
Contains    
Packaging
#Item CodePackage Description
1NDC:63941-970-242 in 1 CARTON
112 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33608/10/2010
Labeler - Valu Merchandisers Company (Best Choice) (868703513)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 11/2012
Document Id: 7d9d5366-7d3f-457a-b782-25008fd10d64
Set id: 7b6b2787-1924-44c5-b312-b9b2f11bf094
Version: 1
Effective Time: 20121113
 
Valu Merchandisers Company (Best Choice)