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Sleep Aid by Topco Associates, LLC

Medically reviewed on January 15, 2018

Dosage form: tablet, film coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Topco Associates, LLC
NDC Code: 36800-672

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.

Topcare 44-672

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses
  • for 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
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

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 are

taking sedatives or tranquilizers or any other sleep aid.

When using this product
  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • 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 (50 mg) at bedtime if needed, or as directed by a doctor
  • children under 12 years: do not use

Other information
  • each caplet contains: calcium 70 mg
  • avoid excessive heat (greater than 100°F) or humidity
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

Inactive ingredients

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

TopCare®

NDC 36800-672-06

CAPLETS

Sleep
Aid

DIPHENHYDRAMINE HCl

NIGHTTIME SLEEP-AID

• Non-habit forming

• Not for treating cold or flu

ACTUAL SIZE

200 CAPLETS - 25 mg EACH

COMPARE TO 
VICKS® ZZZQUIL™
active ingredient*

QUALITY GUARANTEED

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO LNK616
QUESTIONS? 1-888-423-0139
topcare@topco.com www.topcarebrand.com

Topcare 44-672

SLEEP AID 
diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-672
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
D&C RED NO. 27 ALUMINUM LAKE 
FD&C BLUE NO. 2 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
SILICON DIOXIDE 
TALC 
TITANIUM DIOXIDE 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
POLYVINYL ALCOHOL, UNSPECIFIED 
Product Characteristics
ColorPURPLEScoreno score
ShapeOVALSize14mm
FlavorImprint Code44;672
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-672-06200 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33807/24/2015
Labeler - Topco Associates, LLC (006935977)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088MANUFACTURE(36800-672), PACK(36800-672)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(36800-672)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(36800-672)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(36800-672)

 
Topco Associates, LLC

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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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