Your browser does not support JavaScript! NIGHTTIME SLEEP EASY (DIPHENHYDRAMINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION (READYINCASE)]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

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


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 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 enlarged prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

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.

If 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 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 15º-30ºC (59º-86ºF)
  • avoid excessive heat and humidity

Inactive ingredients

carnauba wax*, colloidal silicon dioxide*, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
 

PRINCIPAL DISPLAY PANEL

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

readyincase™

nighttime

sleep-aid

diphenhydramine HCl 25 mg

non-habit forming

fall asleep fast wake up rested

does not contain pain reliever

caplets

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

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

Product Labeling

Diphenhydramine HCl 25 mg

Readyincase Nighttime Sleep-aid

NIGHTTIME SLEEP EASY 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 DescriptionMarketing Start DateMarketing End Date
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 FINALpart33812/04/2012
Labeler - P and L Development of New York Corporation (ReadyInCase) (800014821)

Revised: 4/2014
 
P and L Development of New York Corporation (ReadyInCase)

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services