SLEEP EASY- diphenhydramine hydrochloride tablet, coated
PLD Acquisitions LLC DBA Avéma Pharma Solutions

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.

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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

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

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

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63548-6373
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	4mm
Flavor		Imprint Code	S25
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63548-6373-1	24 in 1 BLISTER PACK; Type 0: Not a Combination Product	01/02/2010	02/28/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part338	01/02/2010	02/28/2017

Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)

Revised: 3/2017

Document Id: 530a418a-c368-4282-b129-e7d4ae34dcae

Set id: 058eef84-fdbc-4f27-a619-72e89d535766

Version: 2

Effective Time: 20170331

PLD Acquisitions LLC DBA Avéma Pharma Solutions