Extra Strength Antacid Tablet, Chewable
FDA Label NDC 70000-0234

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Extra Strength Antacid (NDC 70000-0234). 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 tablet), purpose, uses, warnings, ask a doctor or pharmacist before use if you are, when using this product, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Tablet)

Aluminum hydroxide 160 mg

Magnesium carbonate 105 mg

Purpose

Antacid

Antacid

Uses

relieves

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms

Warnings

Consuming this product can expose you to chemicals including lead, which is known to the State of California to cause cancer. For more information, go to www.P65Warningd.ca.gov

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking a prescription drug. Antacids may interact with certain prescription drugs
  • If you are on a sodium-restricted diet

When Using This Product

  • do not take more than 16 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

1-800-222-1222

Directions

  • chew 2 to 4 tablets four times a day or as directed by a doctor
  • take after meals and at bedtime or as needed
  • for best results follow by a half glass of water or other liquid
  • DO NOT SWALLOW WHOLE

Other Information

  • Each tablet contains: magnesium 31 mg, sodium 19 mg
  • Store at room temperature.

Inactive Ingredients

alginic acid, calcium stearate, compressible sugar, flavor, sodium bicarbonate, starch (corn), sucrose.

Principal Display Panel

LEADER™

NDC 70000-0234-1

COMPARE TO GAVISCON® EXTRA STRENGTH ANTACID active ingredients*

Extra Strength

Antacid Tablets

Aluminum Hydroxide, 160 mg

Magnesium Carbonate, 105 mg

Original Flavor

  •  Helps Keep Acid Down for Hours
  •  Fast-Acting Heartburn Relief

    • 100 Chewable Tablets

    100% Money Back Guarantee

    •  DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING

      • ©2018 Cardinal Health. All Right Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER and the Leader LOGO are trademarks or registered

      trademarks of Cardinal Health. All other marks are the property of their respective owners.

      DISTRIBUTED BY CARDINAL HEALTH

      DUBLIN, OHIO 43017

      www.myleader.com 1-800-200-6313

      All LEADER™ Brand Products Have A 100% Money Back Guarantee. Return to place of purchase if not satisfied.

      This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademarks of Gaviscon® Extra Strength Antacid.

      Extra Strength Original Flavor Antacid Tablets Aluminum Hydroxide, Magnesium Carbonate (35d01fe6 542e 41fe A81b 49e1077a7e8e 01)

      Extra Strength Original Flavor Antacid Tablets Aluminum Hydroxide, Magnesium Carbonate (35d01fe6 542e 41fe A81b 49e1077a7e8e 01)

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