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Rest Simply by Chain Drug Consortium

Medically reviewed on December 14, 2017

Dosage form: tablet, film coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Chain Drug Consortium
NDC Code: 68016-682

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 44-367

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg 

Purpose

Nighttime sleep-aid 

Use

for relief of occasional sleeplessness 

Warnings

Do not use
  • in children under 12 years of age
  • 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
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers. 

When using this product
  • use caution when driving a motor vehicle or operating machinery
  • drowsiness will occur
  • avoid alcoholic beverages

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
  • do not take more than directed
  • adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor
  • children under 12 years: do not use 

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

Inactive ingredients

corn starch, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silica gel, stearic acid, talc, titanium dioxide 

Questions or comments?

1-800-426-9391 

Principal Display Panel

Premier
Value®

*COMPARE TO THE ACTIVE INGREDIENT
IN SIMPLY SLEEP®

Rest Simply
Diphenhydramine HCl 25 mg
NIGHTTIME SLEEP-AID

Wake up rested and refreshed
Does NOT contain pain reliever

Safe, non-habit forming

24 Caplets

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

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.

*This product is not manufactured or distributed by McNeil
Consumer Healthcare, owner of the registered trademark
Simply Sleep®.
50844        REV0516A36708

Premier Value 44-367

REST SIMPLY 
diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-682
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
TALC 
TITANIUM DIOXIDE 
SILICON DIOXIDE 
STEARIC ACID 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize11mm
FlavorImprint Code44;367
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-682-242 BLISTER PACK in 1 CARTON
112 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33806/10/2000
Labeler - Chain Drug Consortium (101668460)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(68016-682)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(68016-682)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088MANUFACTURE(68016-682), PACK(68016-682)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(68016-682)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(68016-682)

 
Chain Drug Consortium

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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