Unisom SleepTabs description, usages, side effects, indications, overdosage, supplying and lots more!

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Unisom SleepTabs

Chattem, Inc.

Unisom SleepTabs




FULL PRESCRIBING INFORMATION

Drug Facts

Doxylamine succinate 25 mg

Nighttime sleep-aid

  • helps to reduce difficulty in falling asleep

in children under 12 years of age

  • a breathing problem such as asthma, emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

are taking any other drugs

  • avoid alcoholic beverages
  • take only at bedtime
  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
  • sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.

ask a health professional before use.

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

  • adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
  • children under 12 years of age: do not use
  • store at 20 - 25ºC (68 - 77ºF)

dibasic calcium phosphate, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate

Value Size
Unisom® SleepTabs®
Doxylamine succinate tablets, 25 mg 
NIGHTTIME SLEEP-AID
48 Tablets
One Tablet per dose

Unisom SleepTabs

Unisom SleepTabs

Doxylamine Succinate TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41167-0060
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOXYLAMINE SUCCINATE DOXYLAMINE 25 mg

Inactive Ingredients

Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
FD&C BLUE NO. 1
ALUMINUM OXIDE
MAGNESIUM STEARATE
cellulose, microcrystalline

Product Characteristics

Color Size Imprint Code Shape
BLUE 13 mm U OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 8 in 1 BLISTER PACK
2 16 in 1 BLISTER PACK
3 32 in 1 BLISTER PACK
4 48 in 1 BLISTER PACK
5 NDC:41167-0060-3 6 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018066 1978-10-18


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Be sure to consult your doctor before taking any medication!
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