Leader 44-386-Discontinued

Sleep Aid by

Drug Labeling and Warnings

Sleep Aid by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SLEEP AID- doxylamine succinate tablet 
CARDINAL HEALTH

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Leader 44-386-Discontinued

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 20°-25°C (68°-77°F)
  • 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

NDC: 37205-671-64

LEADER®

Compare to
Unisom® Sleep Tabs®
active ingredient*

Sleep Aid
Doxylamine succinate 25 mg
Nighttime Sleep-Aid

Fall Asleep Fast/Safe

One Tablet Per Dose

32 TABLETS

Easy to Swallow

Actual Size

SATISFACTION GUARANTEED

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

*This product is not manufactured or distributed by Chattem, Inc.,
owner of the registered trademark Unisom® SleepTabs®.
50844       REV0513B38627

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
CIN 4557161
www.myleader.com      1-800-200-6313

All Leader®Brand products are
100% satisfaction guaranteed
or return to place of purchase
for a full refund.

Leader 44-386

Leader 44-386

SLEEP AID 
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 37205-671
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorBLUEScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code 44;386
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 37205-671-642 in 1 CARTON04/11/200202/21/2020
116 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04056404/11/200202/21/2020
Labeler - CARDINAL HEALTH (097537435)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(37205-671)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(37205-671)

Revised: 7/2017
Document Id: 68a31c52-9505-4918-a515-f39e94930326
Set id: 4b8adfd2-caf6-4376-ae7e-b82e9c405fb2
Version: 6
Effective Time: 20170711
 
CARDINAL HEALTH