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

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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

Use

for relief of occasional sleeplessness.

Warnings

Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

avoid alcoholic drinks.

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.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Sleep Aid Other information

  • store at 15°-30°C (59°-86°F)

Inactive ingredients

edible white ink, FD&C blue #1, gelatin, glycerin, light mineral oil*, polyethylene glycol, purified water, sorbitol-sorbitan

*may contain this ingredient

Questions or comments?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient of UNISOM® SLEEPGELS®   **See bottom panel

MAXIMUM STRENGTH

Sleep-Aid Softgels

Diphenhydramine HCl, 50 mg

Nighttime Sleep-Aid

Safe, Non-Habit Forming

LIQUID FILLED SOFTGELS one softgel per dose

**Unisom® SleepGels® is a registered trademark of Chattem, Inc., Chattanooga, TN 37409. Chattem, Inc., is not affiliated with The Kroger Co. or this product.

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OH 45202

www.kroger.com

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Package Label

Sleep Aid
Kroger Maximum Strength Sleep-Aid Softels

Sleep Aid

Diphenhydramine HCl CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:30142-236
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
LIGHT MINERAL OIL
POLYETHYLENE GLYCOLS
water
SORBITAN
sorbitol

Product Characteristics

Color Size Imprint Code Shape
BLUE 13 mm P50;A99;S90 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 32 in 1 BOTTLE, PLASTIC
2 64 in 1 BOTTLE, PLASTIC
3 NDC:30142-236-64 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-02-01


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Be sure to consult your doctor before taking any medication!
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