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Sleep Aid by Chain Drug Consortium

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Chain Drug Consortium
NDC Code: 68016-639

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.

Premier Value 44-189

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg 

Purpose

Nighttime sleep-aid 

Use

helps to reduce difficulty falling asleep 

Warnings

Do not use
  • with any other product containing diphenhydramine, even one used on skin 
  • in children under 12 years of age

Ask a doctor before use if you have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • 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
  • avoid alcoholic beverages
  • drowsiness will occur
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. 

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 (1-800-222-1222) right away. 

Directions
  • each tablet contains: calcium 60 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER UNIT IS TORN OR BROKEN
  • children under 12 years: do not use 

Other information
  • each tablet contains: calcium 60 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • protect from moisture
  • see end flap for expiration date and lot number
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid 

Questions or comments?

1-800-426-9391 

Principal Display Panel

Premier
Value®

*COMPARE TO THE ACTIVE INGREDIENT IN
 ORIGINAL FORMULA SOMINEX®

Sleep Aid
Diphenhydramine HCl 25 mg
NIGHTTIME SLEEP AID

Wake Up Rested and Refreshed
Doctor preferred sleep ingredient

16 Tablets

PV
INDEPENDANTLY TESTED
SATISFACTION GUARANTEED

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Original Formula Sominex®.

50844     REV0516A18921

Distributed by:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087

If for any reason you are not satisfied with
this product, please return it to the store
where purchased for a full refund.

Premier Value 44-189


SLEEP AID 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-639
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
STEARIC ACID 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code44;189
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-639-324 BLISTER PACK in 1 CARTON
18 TABLET in 1 BLISTER PACK
2NDC:68016-639-162 BLISTER PACK in 1 CARTON
28 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33804/10/1990
Labeler - Chain Drug Consortium (101668460)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(68016-639)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(68016-639)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(68016-639)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(68016-639)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(68016-639)

 
Chain Drug Consortium

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Medically reviewed on May 14, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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