Antacid Tablet, Chewable
FDA Label NDC 17714-043

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advance Pharmaceutical Inc. for the product Antacid (NDC 17714-043). 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, purpose, uses, warnings, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

(in each tablet)

Calcium Carbonate 500 mg

Purpose

Antacid

Uses

relieves

  • acid indigestion
  • heartburn
  • sour stomach

Warnings

Ask a doctor before use if you have

  • kidney stones
  • a calcium-restricted diet

    ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

    Stop use and ask a doctor if symptoms last more than 2 weeks.

Keep Out Of Reach Of Children.

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

Directions

  • chew 1-2 tablets as symptoms occurs.
  • do not take more than 8 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks

Other Information

  • each tablet contains: calcium 200 mg
  • store at room temperature 15-30 °C (59-86 °F)

Inactive Ingredients

Al-lakes (D&C red #27, D&C yellow # 10, FD&C blue #1, FD&C yellow # 6), dextrose, flavors (cherry, lemon, lime, orange), magnesium stearate, maltodextrin

Questions Or Comments

Call 631-981-4600, Monday-Friday, 8.30 am – 4.30 pm ET

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured by: Advance Pharmaceutical Inc. Holtsville, NY 11742

Package Label.Principal Display Panel

B43c92b6-figure-01 (B43c92b6 Figure 01)

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B43c92b6-figure-02 (B43c92b6 Figure 02)

Calcium Carbonate 500 mg

Antacid tablets

NDC: 17714-043-15 – 150 COUNT

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