SnoozEase description, usages, side effects, indications, overdosage, supplying and lots more!

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SnoozEase

P and L Development of New York Corporation

NIGHTTIME SLEEP-AID


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each softgel)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

SnoozEase 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 and 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 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

SnoozEase 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 ingredients in Vicks® Zzzquil™ LiquiCaps®

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® Zzzquil™ LiquiCaps®

SnoozEase™

Diphenhydramine HCl, 25 mg

Nighttime Sleep-Aid

Not for treating Cold or Flu

See Warnings

12 Softgels**

(**Liquid-Filled Capsules)

Non Habit-Forming

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

Distributed by:

PL Developments, 200 Hicks Street

Westbury, NY 11590, USA

PRODUCT LABEL

SnoozEase
Diphenhydramine HCl 25 mg

SnoozEase

Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59726-225
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 1
GELATIN
GLYCERIN
POLYETHYLENE GLYCOLS
water
FD&C RED NO. 40
sorbitol
titanium dioxide
SORBITAN

Product Characteristics

Color Size Imprint Code Shape
PURPLE 15 mm A41 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 NDC:59726-225-12 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 2013-04-11


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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