Your browser does not support JavaScript! SMART SENSE SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [KMART CORPORATION]
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RxNorm Names

SMART SENSE SLEEP AID (doxylamine succinate) tablet
[Kmart Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

Active ingredient (in each tablet)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Uses

  • 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

Do not give

to children under 12 years of age

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 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 and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
  • children under 12 years of age: do not use

Other information

  • store at 68°-77°F (20°-25°C)
  • retain in carton until time of use
  • see carton end panel for lot number and expiration date

Inactive ingredients

dibasic calcium phosphate, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient of Unisom® SleepTabs®

Actual Size

SLEEP AID TABLETS

Doxylamine Succinate Tablets, 25 mg

Nighttime Sleep-Aid

Proven Effective

Just One Tablet Per Dose

GLUTEN FREE

FALL ASLEEP FAST!

SAFE

Sleep Aid Tablets Carton Image 1

Sleep Aid Tablets Carton Image 1

Sleep Aid Tablets Carton Image 2

Sleep Aid Tablets Carton Image 2

SMART SENSE SLEEP AID 
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-441
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE25 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize10mm
FlavorImprint Code L441
Contains    
Packaging
#Item CodePackage Description
1NDC:49738-441-011 in 1 CARTON
196 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04016712/29/2010
Labeler - Kmart Corporation (008965873)

Revised: 11/2011
Document Id: bb99c54f-c9af-4082-b0d2-792886ee38d9
Set id: bb99c54f-c9af-4082-b0d2-792886ee38d9
Version: 1
Effective Time: 20111126
 
Kmart Corporation

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