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Sleep Aid Nighttime by Cardinal Health

Dosage form: tablet
Ingredients: DOXYLAMINE SUCCINATE 25mg
Labeler: Cardinal Health
NDC Code: 70000-0249

Leader 44-386

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
  • a breathing problem such as asthma, emphysema or chronic bronchitis
  • glaucoma
  • 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
  • take only at bedtime
  • avoid alcoholic beverages

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

Other information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • 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

LEADER™

NDC 70000-0249-1

Sleep Aid

Doxylamine Succinate, 25 mg ι Nighttime Sleep-Aid

Fall Asleep fast
One Tablet Per Dose
Easy to Swallow

32 TABLETS 

ACTUAL SIZE

COMPARE TO
UNISOM® SLEEPTABS®

active ingredient*

100% Money
Back Guarantee

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

CIN 5315494 REV. 2/17

CardinalHealth™

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com    1-800-200-6313
Essential to Care™ since 1979

©2017 Cardinal Health. All Rights Reserved.
CARDINAL HEALTH, the Cardinal Health LOGO,
LEADER, and the Leader LOGO are trademarks
or registered trademarks of Cardinal Health.

All LEADER™ Brand Products Have A 
100% Money Back Guarantee
Return to place of purchase if not satisfied 

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

50844  ORG051338627

Leader 44-386

SLEEP AID  NIGHTTIME
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0249
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
Product Characteristics
ColorBLUEScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code44;386
Contains    
Packaging
#Item CodePackage Description
1NDC:70000-0249-12 BLISTER PACK in 1 CARTON
116 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04056404/11/2002
Labeler - Cardinal Health (097537435)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(70000-0249)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(70000-0249)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(70000-0249)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(70000-0249)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(70000-0249)

 
Cardinal Health

← See all Sleep Aid Nighttime brands

Medically reviewed on Feb 12, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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