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Somnitab

FRED'S, INC.

Freds 44-189


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION




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,


Keep out of reach of children.


  • 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
  • see end flap for expiration date and lot number
  • store at controlled room temperature 15º-30ºC (59º-86ºF)

Principal Display Panel

FRED'S®

Somnitabs
Nighttime Sleep Aid

Diphenhyrdamine HCl 25 mg

Wake Up Rested and Refreshed
Doctor preferred sleep ingredient           

16 tablets - 25 mg Each

Tested Against The Active Ingredient in: SOMINEX®*

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

*This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare, owner of the registered trademark Sominex®.
50844      REV0410B18921

Somnitab
Fred's 44-189

Somnitab

Diphenhydramine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55315-189
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:55315-189-21 1 in 1 CARTON

Marketing Information

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


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