Topcare Dual Action Complete Tablet, Chewable
FDA Label NDC 36800-082

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 Dual Action Complete (NDC 36800-082). 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 ingredients (in each chewable tablet), purpose, use, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, 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 Ingredients (In Each Chewable Tablet)

Famotidine 10 mg

Calcium carbonate 800 mg

Magnesium hydroxide 165 mg

Purpose

Acid reducer

Antacid

Use

relieves heartburn associated with acid indigestion and sour stomach

Warnings

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Do Not Use

  • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
  • with other acid reducers

Ask A Doctor Before Use If You Have

  • had heartburn over 3 months. This may be a sign of a more serious condition.
  • heartburn with lightheadedness, sweating, or dizziness
  • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain

Ask A Doctor Or Pharmacist Before Use If You Are

presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop Use And Ask A Doctor If

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days

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 and over:
  • do not swallow tablet whole: chew completely
  • to relieve symptoms, chew 1 tablet before swallowing
  • do not use more than 2 chewable tablets in 24 hours
  • children under 12 years: ask a doctor

Other Information

  • each tablet contains: calcium 330 mg; magnesium 70 mg
  • Phenylketonurics: Contains Phenylalanine 2.2 mg per tablet
  • read the directions and warnings before use
  • read the bottle label. It contains important information.
  • store at 20-25˚C (68-77˚F)
  • protect from moisture

Inactive Ingredients

anhydrous lactose, aspartame, dextrates, ferric oxide, glyceryl monostearate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, natural peppermint flavor, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc

Questions Or Comments?

1-888-423-0139

Principal Display Panel

COOL MINT FLAVOR

Dual Action Complete

FAMOTIDINE 10 mg

CALCIUM CARBONATE 800 mg

MAGNESIUM HYDROXIDE 165 mg

TABLETS (CHEWABLE)

Acid Reducer plus Antacid

Just one tablet!

Relieves heartburn due to acid indigestion

actual size

COMPARE TO PEPCID COMPLETE® active ingredients

25 CHEWABLE TABLETS

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