Sleep Easy

Avema Pharma Solutions

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each caplet)
• Purpose
• Sleep Easy Uses
• Warnings
• Directions
• Sleep Easy Other information
• Inactive ingredients
• Package/Label Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Sleep Easy 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

• 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.

• drowsiness may occur
• avoid alcoholic drinks
• do not drive a motor vehicle or operate machinery

• 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

Sleep Easy 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.