NIGHTTIME SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled 
WALGREEN COMPANY

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Wal-Sleep Z NIGHTTIME SLEEP-AID

Drug Facts

Active ingredients (in each softgel)

Diphenhydramine HCl 25 mg

Purpose

nighttime sleep-aid

Uses

  • for the 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.

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 aretaking sedatives, tranquilizers or any other sleep aid

When using this product

  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor ifsleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

If pregnant or breast-feeding,ask a health professional before use.

Keep out of reach of children.Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. 1(800)222-1222

Directions

  • take only one dose per day (24 hours) - see Overdose warning
adults & children 12 yrs & over One dose=TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor
 children under 12 years Do not use

Other information

  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F) and high humidity
  • Protect from light

Inactive ingredients

FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, propylene glycol, polyethylene glycol-400, povidone, purified water, sorbitol sorbitan solution

Questions or comments?

1-800-373-6981

Distributed by: Walgreen co.
200 Wilmot rd., Deerfield, IL 60015

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in ZzzQuil®*

NIGHTTIME SLEEP-AID

DIPHENHYDRAMINE HCl 25 mg

SleepZ BOX 24 ct-Die Line

SleepZ BOX 48 ct Die Line

NIGHTTIME SLEEP AID 
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1174
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONE (UNII: FZ989GH94E)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
SORBITAN (UNII: 6O92ICV9RU)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorpurpleScoreno score
ShapeCAPSULE (OBLONG) Size15mm
FlavorImprint Code SD13
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-1174-242 in 1 CARTON10/21/2023
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0363-1174-484 in 1 CARTON10/21/2023
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01010/21/2023
Labeler - WALGREEN COMPANY (008965063)
Registrant - Shield Pharmaceuticals Corp (118724924)
Establishment
NameAddressID/FEIBusiness Operations
Bajaj Nutraceuticals871418313manufacture(0363-1174)

Revised: 11/2023
Document Id: 0ab76a91-a11d-65cc-e063-6294a90aa6f2
Set id: e96ec4d4-53b9-4636-a58c-1a5923a021ad
Version: 3
Effective Time: 20231121
 
WALGREEN COMPANY