Topcare Sleep Aid Tablet
FDA Label NDC 36800-441

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Sleep Aid (NDC 36800-441). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, use, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Use

  • helps to reduce difficulty in falling asleep

Do Not Use

in children under 12 years of age

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

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. (1-800-222-1222)

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

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

Questions Or Comments?

1-888-423-0139

Principal Display Panel

HELPS TO REDUCE DIFFICULTY IN FALLING ASLEEP

Sleep Aid Tablets

DOXYLAMINE SUCCINATE TABLETS, 25 mg

NIGHTTIME SLEEP-AID

Clinically tested, proven effective

One tablet per dose

actual size

COMPARE TO UNISOM® SLEEPTABS® active ingredient

32 TABLETS

* Please review the disclaimer below.