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Sleep Aid

Cardinal Health

Leader 44-386


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients

 Doxylamine succinate 25 mg

Purpose

 Nighttime sleep-aid

Use(s)

 helps to reduce difficulty in falling asleep

Warnings

Ask a doctor before use if you have

  • glaucoma
  • a breathing problem such as asthma, emphysema or chronic bronchitis

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 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.

Directions

  • adults: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
  • do not give to children under 12 years of age 

Sleep Aid Other information

  • store at controlled room temperature 20º-25ºC (68º-77ºF) [See USP]
  • see end flap for expiration date and lot number 

Inactive ingredients

 dicalcium phosphate, FD&C blue #1 aluminum lake, magnesiums stearate, microcrystalline cellulose, sodium starch glycolate

Questions

 Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal display panel

 LEADER®

Compare to Unisom® Sleep Tabs®

Sleep Aid

Doxylamine succinate 25 mg

Nighttime Sleep-Aid

Fall Asleep Fast/Safe

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

50844     REV0610A38627

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN 4557161

Sleep Aid

Sleep Aid

Doxylamine succinate TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37205-671
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
MAGNESIUM STEARATE
cellulose, microcrystalline
SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics

Color Size Imprint Code Shape
BLUE 10 mm 44;386 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 32 in 1 BLISTER PACK
2 NDC:37205-671-64 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040564 2002-04-11


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