SLEEP AID DYE-FREE NIGHTTIME- diphenhydramine hcl tablet, film coated 
Walgreen Company

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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Walgreens 44-627

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

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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

  • drowsiness will occur
  • avoid alcoholic beverages
  • do not drive a motor vehicle or operate 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

  • 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 28 mg 
  • 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, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc

Questions or comments?

1-800-426-9391

Principal Display Panel

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDED⧧

NDC 0363-0627-12

DYE-FREE • NIGHTTIME
Sleep Aid

Diphenhydramine HCl 25 mg / 
Nighttime Sleep Aid

• For a restful night's sleep
• Does not contain pain reliever
• Safe, non-habit forming

100
 MINI-CAPLETS

Actual Size

DYE-FREE

NIGHTTIME

Compare to Simply Sleep®
active ingredient‡‡

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

⧧Walgreens Pharmacist Survey Study,
   November 2014.

‡‡This product is not manufactured
    or distributed by McNeil Consumer
    Healthcare, owner of the registered
    trademark Simply Sleep®.
    50844        REV0915A62712

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
Walgreens
100% SATISFACTION GUARANTEED
walgreens.com    ©2016 Walgreen Co.

Walgreens 44-627

Walgreens 44-627



SLEEP AID  DYE-FREE NIGHTTIME
diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0627
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize11mm
FlavorImprint Code 44;627
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0627-121 in 1 CARTON07/01/201310/19/2021
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33807/01/201310/19/2021
Labeler - Walgreen Company (008965063)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(0363-0627)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088MANUFACTURE(0363-0627) , PACK(0363-0627)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(0363-0627)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(0363-0627)

Revised: 12/2018
Document Id: e8db5ec4-ac47-4b61-93a1-11b3e53888ab
Set id: 9dffb117-ac01-48e3-83a2-f5acbdd8fdac
Version: 7
Effective Time: 20181211
 
Walgreen Company