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Sleep Aid by Harmon Store Inc.

Medically reviewed on February 25, 2017

Dosage form: tablet, film coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Harmon Store Inc.
NDC Code: 63940-627

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.

Core Values 44-627

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
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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
  • drowsiness will occur
  • avoid alcoholic beverages
  • 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 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
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture
  • use by expiration date on package

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

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CORE VALUES™

Compare to active ingredient in
Simply Sleep®

NDC 63940-627-03

Sleep Aid

Diphenhydramine HCl 25 mg
Nighttime Sleep-Aid

Dye-Free • Non-habit Forming

Actual Size

10 coated caplets

TAMPER EVIDENT: Use Only if This Blister is Intact

This product is not
manufactured or distributed by
McNeil Consumer Healthcare,
owner of the registered
trademark Simply Sleep®.

50844     REV0516A62703

Satisfaction Guaranteed Or Your Money Back
Visit us at www.facevalues.com

Distributed by:
Liberty Procurement, Inc., 650 Liberty Ave., Union, NJ 07083 U.S.A.

Core Values 44-627

SLEEP AID 
diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-627
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POLYVINYL ALCOHOL, UNSPECIFIED 
STEARIC ACID 
TALC 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
SILICON DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize11mm
FlavorImprint Code44;627
Contains    
Packaging
#Item CodePackage Description
1NDC:63940-627-031 BOTTLE in 1 PACKAGE
110 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33807/01/2013
Labeler - Harmon Store Inc. (804085293)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(63940-627)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(63940-627)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(63940-627)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088MANUFACTURE(63940-627), PACK(63940-627)

 
Harmon Store Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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