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Name:Nighttime Sleep Aid
Manufacturer:Cvs Pharmacy
Category:Over-the-counter (OTC) Marketed Drugs


CVS Pharmacy, Inc. Nighttime Sleep Aid Tablets Drug Facts

NIGHTTIME SLEEP AID - doxylamine succinate tablet 
CVS Pharmacy

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CVS Pharmacy, Inc. Nighttime 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®

Nighttime

Sleep Aid

Doxylamine Succinate Tablets, 25 mg USP

Nighttime Sleep Aid

Fall Asleep Fast

Safe. Proven Effective

Just One Tablet Per Dose

Actual Size

Nighttime Sleep Aid Tablets Carton

Nighttime Sleep Aid Tablets Carton


NIGHTTIME SLEEP AID 
doxylamine succinate tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-441
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 25 mg
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 10mm
Flavor Imprint Code L441
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-441-64 2 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 16 TABLET ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (59779-441-64)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040167 07/23/1997

Labeler - CVS Pharmacy (062312574)

Revised: 06/2009 CVS Pharmacy



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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