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Somnitabs

GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.

Healthcare 44-189


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Diphenhydramine HCl 25 mg

Nighttime Sleep-Aid

helps reduce difficulty falling asleep

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 you have

  • 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 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. 

  • adults and children 12 years and older; take 2 tablets at bedtime if needed or as directed by a doctor
  • children under 12 years: do not use
  • store at controlled room temperature 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

croscarmellose sodium, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Principal Display Panel

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

HEALTHCARE™

NDC 64092-010-16

Somnitabs

Nighttime Sleep Aid

with Diphenhydramine HCl 25 mg

An Aid to Sleep

*Compare to the active ingredient in Sominex®

16 TABLETS

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

50844   REV0410A18921

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

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

www.glwholesale.com

Somnitabs

Somnitabs

Diphenhydramine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:64092-010
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
FD&C BLUE NO. 1
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
BLUE 10 mm 44;189 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 16 in 1 BLISTER PACK
2 NDC:64092-010-16 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 1992-12-25


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Be sure to consult your doctor before taking any medication!
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