Your browser does not support JavaScript! NIGHTTIME SLEEP EASY (DIPHENHYDRAMINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION]
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RxNorm Names

NIGHTTIME SLEEP EASY (diphenhydramine hcl) tablet
[P and L Development of New York Corporation]


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 25mg

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 enlarged prostate gland glaucoma

Ask a doctor of pharmacist before use if

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

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

Pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children

Overdose warning: in the 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 betime if needed or as directed by a doctor
Children under 12 years of age: do not use.

Other information

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

Inactive Ingredients

carunauba wax*, colloidal silicon dioxide*, croscarmellose sodium, dibasic calcium phosphate dihydrate, FDandC blue #1 aluminum lake, magnesium stearate, microcyrstalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide * contains one or more of these ingredients.

Questions or Comments?

Call 1-877-753-3935
Monday through Friday 9AM - 5PM EST
 
**This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol(r) Simply sleep(R)

Product Labeling

Night Time Sleep Easy

NDC 59726-400-12

Diphenhydramine HCl 25mg


Does not contain pain reliever
Fall asleep fast Wake up rested


Non-habit forming
12 mini-caplets

Distributed by PL Developments
Westbury, NY 11590 USA

sleepeasy

NIGHTTIME SLEEP EASY 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-400
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
Colorblue (blue) Scoreno score
ShapeCAPSULESize11mm
FlavorImprint Code T129;S25
Contains    
Packaging
#Item CodePackage Description
1NDC:59726-400-1212 in 1 BOX
112 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/04/2012
Labeler - P and L Development of New York Corporation (800014821)

Revised: 12/2012
Document Id: e62f2525-39c6-4e49-9a2a-a5fcb2de15f7
Set id: 9003d56b-d930-4876-b074-75e360a4fd01
Version: 1
Effective Time: 20121204
 
P and L Development of New York Corporation

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