EZ Nite Sleep

P and L Development of New York Corporation

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each softgel)
• Purpose
• EZ Nite Sleep Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• EZ Nite Sleep Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel
• Package Label

FULL PRESCRIBING INFORMATION

Active ingredient (in each softgel)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

EZ Nite Sleep Uses

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

Warnings

Do not use

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

Ask a doctor before use if you have

• a breathing problem such as asthma, emphysema, or chronic bronchitis
• glaucoma
• heart disease
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers or any other sleep-aid.

When using this product

• drowsiness will occur
• avoid alcoholic beverages and other drugs that cause drowsiness
• 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 a 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  
• swallow whole; do not crush, chew, or dissolve
• adults & children 12 yrs & over
  • one dose = TWO 25 mg softgels (50 mg) at bedtime if needed or as directed by a doctor

EZ Nite Sleep Other information

• store at 20-25° C (68-77° 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-sorbitan solution, titanium dioxide

Questions or comments?

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

Principal Display Panel

*Compare to the active ingredient in ZZZQUIL®

EZ Nite Sleep

Diphenhydramine HCl 25 mg

Nighttime Sleep-Aid

Not for treating Cold or Flu

See Warnings

SOFTGELS**

(**Liquid-Filled Capsules)

Non Habit-Forming

Distributed by:

PL Developments, 200 Hicks Street

Westbury, NY 11590, USA

Product of Canada

Failure to follow these warnings could result in serious consequences.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

*This product is not manufactured or distributed by The Procter & Gamble Company. ZZZQUIL® is a registered trademark of The Procter & Gamble Company.

Package Label