NIGHTTIME SLEEP AID- diphenhydramine hcl 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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DRUG FACTS

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep- aid

Use

Warnings

Do not give to children under 12 years of age.

Do not use this product

Ask a doctor before use if you have

Ask doctor or pharmacist before use if you are now taking

sedatives or tranquilizers

When using this product

avoid alcoholic beverages

Stop use and ask a doctor if

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

Other information

Inactive ingredients

edible white ink, FD&C Blue #1, gelatin, glycerin, polyethylene glycol, purified water and sorbitol special.

Questions or comments ?

call toll free 1-877-753-3935

Principal Display Panel

*Compare to the Active Ingredient in Maximum Strength Unisom SleepGels®

Nighttime Sleep Aid

Diphenhydramine HCl 50 mg

Helps to reduce difficulty falling asleep

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

Best Choice nighttime sleep aid

Diphenhydramine HCl 50 mg

NIGHTTIME SLEEP AID 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-230
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize13mm
FlavorImprint Code P50;A99
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63941-230-162 in 1 CARTON
18 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/26/2010
Labeler - Valu Merchandisers Company (Best Choice) (868703513)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 11/2012
Document Id: 8e96e588-8268-4ceb-b2f1-02d208cfedaf
Set id: 6ef61442-cb62-4157-a971-0f5b826c9c3f
Version: 1
Effective Time: 20121115
 
Valu Merchandisers Company (Best Choice)