Your browser does not support JavaScript! TOPCARE SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [TOPCO ASSOCIATES LLC]
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RxNorm Names

TOPCARE SLEEP AID (doxylamine succinate) tablet
[Topco Associates LLC]


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?

1-888-423-0139

Principal Display Panel

Fall Asleep Fast!

Safe

Sleep Aid Tablets

Doxylamine Succinate Tablets, 25 mg

Nighttime Sleep-Aid

Proven Effective

Just One Tablet Per Dose

Actual Size

Compare to Unisom® SleepTabs® active ingredient

Sleep Aid Tablets Carton

Sleep Aid Tablets Carton

TOPCARE SLEEP AID 
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:36800-441
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE25 mg
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize10mm
FlavorImprint Code L441
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-441-642 in 1 CARTON
116 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04016701/29/1997
Labeler - Topco Associates LLC (006935977)

Revised: 6/2009
 
Topco Associates LLC

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