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

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Sleep Aid

TOP CARE (Topco Associates LLC)

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?

Call toll free 1-888-423-0139

Principal Display Panel

Maximum Strength

Sleep-Aid

Nighttime Liquidcaps  (Liquid Filled Softgels)

Diphenhydramine Hydrochloride, 50 mg

SOFTGELS

Compare to Unisom® SleepGels® active ingredient**

**This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels®.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.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

Top Care Maximum Strength Sleep-Aid Softgels
 

Sleep Aid

Diphenhydramine HCl CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:36800-236
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 64 in 1 BOTTLE, PLASTIC
2 32 in 1 BOTTLE, PLASTIC
3 NDC:36800-236-03 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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