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Sleep Aid

COSTCO WHOLESALE CORPORATION

Kirkland 44-386


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Use

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 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 end flap for expiration date and lot number 

Inactive ingredients

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

Questions or comments?

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

Principal display panel

KIRKLAND Signature

COMPARE TO UNISOM® SLEEPTABS®
active ingredient*

NDC 63961-386-46
ITM./ART.
719940

SLEEP AID
Doxylamine Succinate Tablets, 25 mg
Nighttime Sleep Aid

Fall Asleep Fast!
Safe, Proven Effective
Just One Tablet Per Dose

2 x 96 TABLETS

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® Sleeptabs®.
50844    REV0610A38646

CONTENTS NOT LABELED FOR INDIVIDUAL SALE

This Product Does Not Contain Gluten.

Manufactured by:
LNK INTERNATIONAL, INC.,
60 Arkay Drive
Hauppauge, NY 11788 USA
1-800-426-9391
For Costco Wholesale Corporation
P.O. Box 34535
Seattle, WA 98124-1535
www.costco.com

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Sleep Aid
Kirkland 44-386

Sleep Aid

Doxylamine succinate TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63981-386
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 96 in 1 BOTTLE, PLASTIC
2 NDC:63981-386-46 2 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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