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Sleep Aid

THE KROGER CO

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep- aid

Sleep Aid Uses

  • helps to reduce difficulty falling asleep

Warnings

Do not give to children under 12 years of age.

Do not use

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

Ask a doctor before use if you have

  • emphysema
  • chronic bronchitis
  • glaucoma
  • difficulty in urination due to an enlargement of the prostate gland

Ask doctor or pharmacist before use if you are now taking


When using this product

Avoid alcoholic beverages

Stop use and ask a doctor if

  •  sleeplessness persists for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

If pregnant or breast-feeding,


Keep out of reach of children.


Directions

  • adults and children 12 years of age and over: take 1 softgel at bedtime if needed or as directed by a doctor

Sleep Aid Other information

  • Store at controlled room temperature 15°-30°C (59°-86°F)
  • do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

Questions or comments ?

call toll free 1-800-632-6900

Product Label

KROGER®

Sleep Aid

Diphenhydramine HCl, 50 mg

MAXIMUM STRENGTH

  • Helps to reduce difficulty falling asleep

Compare to active ingredient in Maximum Strength Unisom Sleepgels® *See bottom panel

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Sleep Aid
Nighttime Sleep Aid

Sleep Aid

Diphenhydramine HCl CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:30142-230
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 50 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 1
GELATIN
GLYCERIN
POLYETHYLENE GLYCOLS
water
sorbitol

Product Characteristics

Color Size Imprint Code Shape
BLUE 13 mm P50;A99 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 32 in 1 BOTTLE
2 64 in 1 BOTTLE
3 NDC:30142-230-64 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-07-12


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