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Leader Sleep Aid

Pronunciation

Generic Name: doxylamine succinate
Dosage Form: tablet

Cardinal Health Sleep Aid Tablets Drug Facts

Active ingredient (in each tablet)

Doxylamine succinate 25 mg

Slideshow: OTC Medication Use In Pregnancy: Wise or Worrisome?

Purpose

Nighttime sleep-aid

Uses

  • helps to reduce difficulty in falling asleep

Warnings

Ask a doctor before use if you have

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

Do not give

to children under 12 years of age

Ask a doctor or pharmacist before use if you are

taking any other drugs

When using this product

  • avoid alcoholic beverages
  • take only at bedtime

Stop use and ask a doctor if

  • sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of 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.

Directions

  • 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

Other information

  • store at 68°-77°F (20°-25°C)
  • retain in carton until time of use
  • see carton end panel for lot number and expiration date

Inactive ingredients

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

Questions or comments?

1-800-719-9260

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Compare to Unisom® SleepTabs® active ingredient

Fall Asleep Fast!

Safe

Sleep Aid Tablets

Doxylamine Succinate Tablets, 25 mg

Nighttime Sleep-Aid

Proven Effective

Just One Tablet Per Dose

Actual Size

Sleep Aid Tablets Carton

Leader Sleep Aid 
doxylamine succinate tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-121
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 25 mg
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 10mm
Flavor Imprint Code L441
Contains         
Packaging
# Item Code Package Description
1 NDC:37205-121-64 2 BLISTER PACK (BLISTER PACK) in 1 CARTON
1 16 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040167 10/21/1997
Labeler - Cardinal Health (097537435)
Revised: 06/2009
 
Cardinal Health



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