CARE ONE SLEEP AID

Dosage form: tablet
Ingredients: DOXYLAMINE SUCCINATE 25mg
Labeler: American Sales Company
NDC Code: 41520-441

American Sales Company Sleep Aid Tablets Drug Facts

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 in Unisom® SleepTabs®

Fall Asleep Fast!

Sleep Aid

Doxylamine Succinate Tablets, 25 mg

Nighttime Sleep-Aid

Safe, Proven Effective.

Just One Tablet Per Dose

Actual Size

Sleep Aid Tablets Carton

CARE ONE SLEEP AID 
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-441
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE25 mg
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize10mm
FlavorImprint CodeL441
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-441-642 BLISTER PACK (BLISTER PACK) in 1 CARTON
116 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04016706/29/2004
Labeler - American Sales Company (809183973)

Revised: 06/2009
 
American Sales Company

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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