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

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Sleep Aid

Geiss, Destin & Dunn, Inc (Goodsense)
P and L Development of New York Corporation

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

helps reduce difficulty falling asleep

Warnings

Do not give to children under 12 years of age.

Do not use this product

with other products 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 a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

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,

ask a health care 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 and over: take 2 tablets at bedtime or as directed by a doctor. For best results, take recommended dose. This will provide approximately 6 to 8 hours of restful sleep.

Sleep Aid Other information

  • each tablet contains: calcium 65 mg
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • avoid excessive heat and humidity
  • **This product is not manufactured or distributed by Glaxosmithkline, owner of the registered trademark Sominex®

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C Blue #1 aluminium lake, magnesium stearate, microcrystalline cellulose, silicon dioxide*, and stearic acid*

*Contains one or more of these ingredients.

Questions or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

**Compare to the active ingredient in Sominex® Original Formula

Regular Strength

Sleep-Aid

wake rested and refreshed

Diphenhydramine HCl 25 mg

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

Product Label

Sleep Aid
Diphenhydramine HCl 25 mg

Sleep Aid

Diphenhydramine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50804-200
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
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
MAGNESIUM STEARATE
cellulose, microcrystalline
SILICON DIOXIDE
FD&C BLUE NO. 1
STEARIC ACID
ALUMINUM OXIDE

Product Characteristics

Color Size Imprint Code Shape
BLUE 10 mm 1008;1008 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 8 in 1 BLISTER PACK
2 NDC:50804-200-16 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part336 2010-08-03


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Be sure to consult your doctor before taking any medication!
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