SLEEP AID NIGHTTIME- doxylamine succinate tablet 
Cardinal Health

----------

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

Leader 44-386

SLEEP AID  NIGHTTIME
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0249
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
Product Characteristics
ColorBLUEScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code 44;386
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0249-12 in 1 CARTON04/11/200202/03/2023
116 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04056404/11/200202/03/2023
Labeler - Cardinal Health (097537435)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(70000-0249)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(70000-0249)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(70000-0249)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(70000-0249)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(70000-0249)

Revised: 2/2020
Document Id: 4072ffbe-a106-4b75-b2ac-527a2e6b0afd
Set id: 08a0b7c4-40b2-4571-b699-de68bca81d17
Version: 4
Effective Time: 20200214
 
Cardinal Health