SLEEP AID DYE-FREE NIGHTTIME- diphenhydramine hydrochloride tablet, film coated 
WALGREEN CO.

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

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
  • trouble urinating due to an enlarged 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 drinks
  • 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.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

Other information

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

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 2012.
⧧⧧This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Simply Sleep®.
50844        ORG031362712

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
Walgreens
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walgreens.com    ©2013 Walgreen Co.

Walgreens 44-627

Walgreens 44-627

SLEEP AID  DYE-FREE NIGHTTIME
diphenhydramine hcl tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0627
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN (UNII: O8232NY3SJ)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 11mm
Flavor Imprint Code 44;627
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0363-0627-12 1 in 1 CARTON
1 100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part338 07/01/2013
Labeler - WALGREEN CO. (008965063)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(0363-0627)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(0363-0627)

Revised: 3/2015
Document Id: 159dc72d-9ef5-4dd2-b440-4b394bcef696
Set id: 9dffb117-ac01-48e3-83a2-f5acbdd8fdac
Version: 2
Effective Time: 20150324
 
WALGREEN CO.