Sleep Easy

Dosage form: tablet, coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Avema Pharma Solutions
NDC Code: 63548-6373

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.

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

provides relief of occasional sleeplessness.

Warnings

  • Do not use with any other products containing diphenhydramine, even one used on skin
  • in children under 12 years of age

Ask a doctor before use if you have
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlargement of the prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product
  • drowsiness may occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate 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 care 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

Do not take more than directed

  • adults and children 12 years of age and over: take 2 caplets at bedtime if needed or as directed by a doctor
  • children under 12 years of age: do not use

Other information
  • each caplet contains: calcium 25 mg
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • avoid excessive heat and humidity

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate dihydrate, FD&C Blue #1 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, and titanium dioxide. May also contain: polyvinyl alcohol and talc.

Package/Label Principal Display Panel

NDC 63548-6373-*1

*Compare to the active ingredient in Tylenol® Simply Sleep®

Nighttime

Sleep Easy

Diphenhydramine HCl 25 mg

For relief of occasional sleeplessness

Non-habit forming

12 MINI-CAPLETS


THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

SLEEP EASY 
diphenhydramine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-6373
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
POLYVINYL ALCOHOL 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize4mm
FlavorImprint CodeS25
Contains    
Packaging
#Item CodePackage Description
1NDC:63548-6373-124 TABLET, COATED (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33801/02/2010
Labeler - Avema Pharma Solutions (804087749)

Revised: 02/2010
 
Avema Pharma Solutions

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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