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topcare sleep aid by Topco Associates LLC

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Topco Associates LLC
NDC Code: 36800-151

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.

Topco Associates LLC. Sleep Aid Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

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
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

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 lasts continuously for more than 2 weeks. Insomnia may be a symptom of 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 overtake 2 caplets at bedtime if needed, or as directed by a doctor
children under 12 years do not use

Other information
  • store at 20º-25ºC (68º-77ºF)

Inactive ingredients

collodial silicon dioxide, crospovidone, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

1-888-423-0139

Principal Display Panel

FALL ASLEEP FAST! • NON HABIT-FORMING

Nighttime

Sleep Aid

DIPHENHYDRAMINE HCl

Contains no pain reliever

actual size

COMPARE TO SIMPLY SLEEP™ active ingredient

Sleep Aid Carton Image 1

Sleep Aid Carton Image 2

TOPCARE SLEEP AID 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-151
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSPOVIDONE 
CELLULOSE, MICROCRYSTALLINE 
POLYVINYL ALCOHOL 
POVIDONE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOLS 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize16mm
FlavorImprint CodeL151
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-151-781 BOTTLE (BOTTLE) in 1 CARTON
1100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33811/03/2010
Labeler - Topco Associates LLC (006935977)

Document Id: 326fc19b-98e2-4781-b2fb-d9aa9a044f05
Set id: 326fc19b-98e2-4781-b2fb-d9aa9a044f05
Version: 1
Effective Time: 20101103
 
Topco Associates LLC

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Medically reviewed on Nov 5, 2018

Further information

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

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