PREMIER VALUE SLEEP-AID - diphenhydramine hcl capsule 
Chain Drug Consortium LLC

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(S)

Diphenhydramine HCl 50 mg

PURPOSE

Nighttime sleep- aid

USE(S)

WARNINGS

Do not give to children under 12 years of age.

DO NOT USE

ASK A DOCTOR BEFORE USE IF

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

Sedatives or tranquilizers

WHEN USING THIS PRODUCT

Avoid alcoholic beverages

STOP USE AND ASK DOCTOR IF

PREGNANCY/BREASTFEEDING

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DIRECTIONS

STORAGE

INACTIVE INGREDIENTS

Gelatin, Sorbitol, Sorbitan, FD&C Blue No. 1, Water, Polyethylene Glycol 400, Povidone K-30

PRINCIPAL DISPLAY PANEL

Carton Label PDP

NDC # 68016-302-32

Sleep-Aid
DIPHENHYDRAMINE HCL 50 mg

GET TO SLEEP FAST
SLEEP SOUNDLY
WAKE REFRESHED

32 Softgels


diphen-carton-lab





Bottle Label PDP

NDC # 68016-302-32

Sleep-Aid
DIPHENHYDRAMINE HCL 50 mg

GET TO SLEEP FAST
SLEEP SOUNDLY
WAKE REFRESHED

32 Softgels


diphen-bott-label

PREMIER VALUE SLEEP-AID 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-302
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)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K30 (UNII: U725QWY32X)  
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize13mm
FlavorImprint Code 22
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-302-321 in 1 CARTON
132 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/31/2013
Labeler - Chain Drug Consortium LLC (101668460)
Registrant - Chain Drug Consortium LLC (101668460)
Establishment
NameAddressID/FEIBusiness Operations
Marksans Pharma Limited925822975MANUFACTURE(68016-302)

Revised: 5/2013
Document Id: d52c0cc9-758f-4f38-98db-eee64023d25c
Set id: d52c0cc9-758f-4f38-98db-eee64023d25c
Version: 1
Effective Time: 20130530
 
Chain Drug Consortium LLC