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Sleep Aid Nighttime by Walgreen Company

Medically reviewed on November 6, 2017

Dosage form: tablet, film coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Walgreen Company
NDC Code: 0363-0367

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.

Walgreens 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

  • glaucoma
  • 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
  • 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 

  • protect from moisture

  • store at 25ºC (77º); excursions permitted between 15°-30°C (59°-86°F)

  • 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

NDC 0363-0367-12

Well at
Walgreens

WALGREENS PHARMACIST RECOMMENDED

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

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    REV0516B36712

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
Walgreens
100% SATISFACTION
          GUARANTEED

walgreens.com  ©2016 Walgreen Co.

Walgreens 44-367

SLEEP AID  NIGHTTIME
diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0367
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize11mm
FlavorImprint Code44;367
Contains    
Packaging
#Item CodePackage Description
1NDC:0363-0367-082 BLISTER PACK in 1 CARTON
112 TABLET, FILM COATED in 1 BLISTER PACK
2NDC:0363-0367-131 BOTTLE in 1 CARTON
2250 TABLET, FILM COATED in 1 BOTTLE
3NDC:0363-0367-121 BOTTLE in 1 CARTON
3100 TABLET, FILM COATED in 1 BOTTLE
4NDC:0363-0367-911 BOTTLE in 1 CARTON
4125 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33806/10/2000
Labeler - Walgreen Company (008965063)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(0363-0367)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(0363-0367)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088MANUFACTURE(0363-0367), PACK(0363-0367)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(0363-0367)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(0363-0367)

 
Walgreen Company

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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