Your browser does not support JavaScript! DYE FREE NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WALGREEN CO.]
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RxNorm Names

DYE FREE NIGHTTIME SLEEP AID (diphenhydramine hcl) tablet
[WALGREEN CO.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

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

  • do not take more than directed (see overdose warning)
  • 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

  • see end flap for expiration date and lot number
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

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

NDC 0363-0627-12

WALGREENS PHARMACIST RECOMMENDED≠

DYE-FREE • NIGHTTIME
Sleep Aid
Diphenhydramine HCl 25 mg

  • For a restful night's sleep
  • Does not contain pain reliever
  • Safe, non-habit forming

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
100% SATISFACTION GUARANTEED
walgreens.com    (c)2013 Walgreen Co.

Walgreens 44-627

Walgreens 44-627

DYE FREE NIGHTTIME SLEEP AID 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0363-0627
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
MAGNESIUM STEARATE 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize13mm
FlavorImprint Code 44;627
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0627-121 in 1 CARTON
1100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33807/01/2013
Labeler - WALGREEN CO. (008965063)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(0363-0627)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(0363-0627)

Revised: 7/2013
 
WALGREEN CO.

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