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Name:Nighttime Sleep
Manufacturer:Walgreen Co.
Category:Over-the-counter (OTC) Marketed Drugs


Walgreen 44-189

NIGHTTIME SLEEP - diphenhydramine hydrochloride tablet 
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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Walgreen 44-189

Active ingredient

Diphenhydramine HCl 25 mg

Purpose

Nighttime Sleep-Aid

Uses

helps reduce difficulty falling asleep

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

  • avoid alcoholic drinks

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 right away.

Directions

  • adults and children 12 years and older; take 2 tablets at bedtime if needed or as directed by a doctor
  • children under 12 years: do not use

Other information

  • store at controlled room temperature 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Product Packaging

 Walgreens

NDC 0363-0189-21

Compare to Sominex® active ingredient*

SLEEP II

Diphenhydramine HCl 25 mg

NIGHTTIME SLEEP-AID

Sleep Safely and Quickly

Wake Up rested and Refreshed

16 TABLETS

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED IF BLISTERED UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

50844    REV0410H18921

Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015-4616

100% Satisfaction Guaranteed   

Product Packaging

Product Packaging



NIGHTTIME SLEEP 
diphenhydramine hcl tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0189
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
FD&C BLUE NO. 1  
MAGNESIUM STEARATE  
Product Characteristics
Color BLUE Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code 44;189
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0189-21 1 BLISTER PACK (1 BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 16 TABLET (16 TABLET) in 1 BLISTER PACK This package is contained within the CARTON (0363-0189-21)
2 NDC:0363-0189-23 1 BLISTER PACK (1 BLISTER PACK) in 1 CARTON contains a BLISTER PACK
2 72 TABLET (72 TABLET) in 1 BLISTER PACK This package is contained within the CARTON (0363-0189-23)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 12/25/1992

Labeler - WALGREEN CO. (008965063)

Revised: 05/2011 WALGREEN CO.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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