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Rest Simply

GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.

Healthcare 44-367


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient(s)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Rest Simply Uses

  • relief of occasional sleeplessness

Warnings

Do not use

  • in children under 12 years of age

  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if

  • glaucoma

  • a breathing problem such as emphysema or chronic bronchitis

  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if

  • taking sedatives or tranquilizers

When using this product

  • drowsiness will 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,

ask a health professional before use.

Keep out of reach of children

Overdose warning: In case of overdose, get medical help or In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed (see Overdose warning)

  • adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor

  • children under 12 years: do not use

Rest Simply Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silica gel, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

HEALTHCARE™

NDC 64092-012-24

Rest Simply

Night Time Sleep Aid

Diphenhydramine Hydrochloride 25 mg

For relief of occasional sleeplessness

• non habit forming

• contains no pain reliever

*Compare to active ingredient

in Simply Sleep®

24 CAPLETS

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

50844     REV0410A36708

Distributed by: Great Lakes Wholesale & Marketing L.L.C.

3729 Patterson Ave., S.E., Grand Rapids, MI 49512

www.glwholesale.com

Rest Simply
Product Packaging

Rest Simply

Diphenhydramine HCl TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:64092-012
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
FD&C BLUE NO. 1
MAGNESIUM STEARATE
cellulose, microcrystalline
polyethylene glycol
POLYVINYL ALCOHOL
STEARIC ACID
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
BLUE 13 mm 44;367 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BLISTER PACK
2 NDC:64092-012-08 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 2000-06-10


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Be sure to consult your doctor before taking any medication!
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