Publix Extra Strength
FDA Label NDC 41415-200

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Publix Super Markets, Inc for the product Publix Extra Strength (NDC 41415-200). 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 (per tablet), purpose, uses, warnings, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (Per Tablet)

Calcium Carbonate USP 750mg

Purpose

Antacid

Uses

relieves

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

Warnings

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

When using this product

  • do not take more than 10 tablets in 24 hours
  • if pregnant do not take more than 6 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.

Directions

  • adults and children 12 years of age and over: chew 2-4 tablets completely as symptoms occur, or as directed by a doctor.
  • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor.

Other Information

  • each tablet contains: elemental calcium 300mg
  • store at room temperature. Keep the container tightly closed

    • SAFETY SEALED: Do not use if printed seal under cap is torn or missing

Inactive Ingredients

adipic acid, D&C red # 27 lake, D&C yellow # 10 lake, dextrose, FD&C blue # 1 lake, FD&C yellow # 6 lake, flavors, magnesium stearate, maltodextrin, starch, sucralose,

Questions Or Comments?

1-888-267-3037

Package/Label Principal Display Panel

Publix®

NDC# 41415-200-96

Compare to the active ingredients in Tums® Extra Strength 750 Assorted Fruit Flavor

extra strength

CALCIUM CARBONATE 750 mg/ ANTACID

ASSORTED FRUIT

96 CHEWABLE TABLETS

GLUTEN-FREE

DISTRIBUTED BY:

PUBLIX SUER MARKETS, INC.,

LAKELAND, FL 33811 publix.com

1-888-267-3037

PUBLIX GUARANTEE: COMPLETE SATISFACTION OR YOUR MONEY BACK

*This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Tums® Extra Strength

Publix Assorted Fruit Antacid Tabltes 96 Counts (102af96pvlflb)

Publix Assorted Fruit Antacid Tabltes 96 Counts (102af96pvlflb)

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