Topcare Sleep Aid

Dosage Form: tablet
Topco 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?

1-888-423-0139

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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

Topcare Sleep Aid  doxylamine succinate  tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 36800-441 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 25 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color BLUE Score no score Shape OVAL Size 10mm Flavor Imprint Code L441 Contains

Packaging # NDC Package Description Multilevel Packaging 1 36800-441-64 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 16 TABLET In 1 BLISTER PACK This package is contained within the CARTON (36800-441-64)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040167	01/29/1997

Labeler - Topco Associates LLC (006935977)

Revised: 06/2009Topco Associates LLC

More Topcare Sleep Aid resources

• Topcare Sleep Aid Side Effects (in more detail)
• Topcare Sleep Aid Use in Pregnancy & Breastfeeding
• Drug Images
• Topcare Sleep Aid Drug Interactions
• Topcare Sleep Aid Support Group
• 8 Reviews for Topcare Sleep Aid - Add your own review/rating

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