SLEEP AID

PuraVation Pharmaceuticals Inc

SLEEP AID (Diphenhydramine 25 mg) capsule, liquid filled

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each softgel)
• Purpose
• SLEEP AID Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • When using this product
• Directions
• SLEEP AID Other information
• Inactive ingredients
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

SLEEP AID Uses

• for the relief of occasional sleeplessness
• reduces time to fall asleep if you have difficulty falling asleep

Warnings

Do not use

• for children under 12 years of age
• with any other product containing diphenhydramine, even one used on skin
• with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask a doctor before use if you have

• a breathing problem such as asthma, emphysema, or chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement of the prostate gland
• heart disease

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid

When using this product

• avoid alcoholic beverages and other drugs that cause drowsiness
• drowsiness will occur
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

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

Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• take only one dose per day (24 hours) -  see Overdose warning

SLEEP AID Other information

• store at room temperature 15°-30°C (59°-86°F)
• avoid excessive heat above 40°C (104°F) and high humidity
• protect from light

Inactive ingredients

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

PRINCIPAL DISPLAY PANEL

Sleep Aid

NIGHTTIME

NDC 76270-150-02

*Compare to the active ingredient in ZzzQuil^®

DIPHENHYDRAMINE HCl 25 mg EACH

Non Habit-Forming

Not for Treating Cold or Flu

See Warnings

12 LIQUID-DILLED SOFTGELS