Walgreens 44-672

Walgreens 44-672

Drug Labeling and Warnings

Drug Details

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WAL-SLEEP Z- 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 44-672

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

  • for relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep

Warnings

Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask a doctor before use if you have

  • a breathing problem such as asthma, emphysema, or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers or any other sleep aid.

When using this product

  • avoid alcoholic beverages and other drugs that cause drowsiness
  • 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

  • do not take more than directed
  • adults and children 12 years and over: take 2 caplets (50 mg) at bedtime if needed, or as directed by a doctor
  • children under 12 years: do not use

Other information

  • each caplet contains: calcium 70 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • avoid excessive heat (greater than 100°F) or humidity
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel


Walgreens

Compare to VICKS®
ZzzQuil® active ingredient††

NDC: 0363-0672-12

Wal-Sleep Z®

DIPHENHYDRAMINE HCl 25 mg / NIGHTTIME SLEEP AID

NIGHTTIME      CAPLETS

Non-habit forming

8
CAPLETS

Actual Size

NOT FOR
TREATING
COLD OR FLU

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

Walgreens Pharmacist Survey

††This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® ZzzQuil®.

50844     ORG021567219

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2018 Walgreen Co.

ORG1018-F

Walgreens 44-672

Walgreens 44-672

WAL-SLEEP Z 
diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0363-0672
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)  
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
Product Characteristics
ColorPURPLEScoreno score
ShapeOVALSize14mm
FlavorImprint Code 44;672
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0363-0672-191 in 1 CARTON07/24/2015
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 0363-0672-121 in 1 PACKAGE07/24/2015
2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC: 0363-0672-51365 in 1 BOTTLE; Type 0: Not a Combination Product07/24/201510/25/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33807/24/2015
Labeler - Walgreen Company (008965063)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(0363-0672)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(0363-0672)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(0363-0672)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088MANUFACTURE(0363-0672) , PACK(0363-0672)

Revised: 11/2018
 
Walgreen Company


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