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Sominex

Medtech Products Inc.

Sominex Original




FULL PRESCRIBING INFORMATION

Drug Facts

(in each tablet)

Diphenhydramine HCl 25mg

Nighttime sleep-aid

helps reduce difficultly falling asleep

  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other antihistamines
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

taking sedatives or tranquilizers

avoid alcoholic beverages

  • be careful when driving a motor vehicle or operating machinery

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

ask a health professional before use.

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

  • adults and children 12 years and over: take 2 tablets at bedtime if needed, or as directed by your doctor
  • each tablet contains: calcium 70 mg
  • store below 25ºC (77ºF)

dibasic calcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch

1-866-255-5202 (English/Spanish) weekdays or visit www.sominex.com

ORIGINAL FORMULA
Sominex
NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCl
72 TABLETS

Sominex

Sominex

Diphenhydramine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63029-555
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
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
FD&C BLUE NO. 1
ALUMINUM OXIDE
MAGNESIUM STEARATE
cellulose, microcrystalline
SILICON DIOXIDE
STARCH, CORN

Product Characteristics

Color Size Imprint Code Shape
BLUE (Light Blue) 10 mm S ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 32 in 1 BLISTER PACK
2 16 in 1 BLISTER PACK
3 72 in 1 BLISTER PACK
4 NDC:63029-555-01 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 2012-06-01


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Be sure to consult your doctor before taking any medication!
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