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Sleep Aid

SUPERVALU INC.

Equaline 44-386


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each tablet)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Sleep Aid Uses

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
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking any other drug.

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 (1-800-222-1222) 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 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 or comments?

Call 1-877-932-7948 24 hours a day, 7 days a week

Principal display panel

equaline®

 compare to the active ingredient in Unisom® SleepTabs®*

sleep aid
tablets
doxoylamine succinate 25 mg

nighttime sleep aid
• fall asleep fast
• just one tablet per dose

48 tablets

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Unisom® SleepTabs®.
50844    ORG051338622

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

Sleep Aid

Equaline 44-386

Sleep Aid

Doxylamine succinate TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41163-386
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 48 in 1 BLISTER PACK
2 NDC:41163-386-22 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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