Titralac Plus
FDA Label NDC 55298-013

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Inova Pharmaceuticals Pty, Ltd for the product Titralac Plus (NDC 55298-013). 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, purpose, uses, otc - ask doctor/pharmacist, otc - stop use, directions, other information, inactive ingredients, 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)

Calcium carbonate 420 mg

(168 mg elemental calcium)

Simethicone 21 mg

Purpose

Antacid

Antigas

Uses

  • relieves symptoms referred to as gas
  • relieves:
    • heartburn
    • sour stomach
    • acid indigestion

Otc - Ask Doctor/Pharmacist

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

Otc - Stop Use

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

Directions

  • chew, swallow or let melt in mouth two tablets every two or three hours as symptoms occur or as directed by a physician
  • do not take more than 19 tablets in a 24 hour period or use maximum dosage for more than two weeks

Other Information

  • sugar free
  • very low sodium content (1.5 mg/tablet)
  • low aluminum content (1.0 mg/tablet)

Inactive Ingredients

glycine, magnesium stearate, saccharin, spearmint oil, starch

  • may also contain croscarmellose sodium

    • For your protection this bottle has a printed foil seal under the cap.

    For Information: 1-800-537-2191

    Made in Australia for 3M

    3M Consumer Health Care

    St. Paul, MN 55144-1000

    © 3M 2008 Cat. 360-10

    3M and Titralac are trademarks of 3M.

    T7562

Principal Display Panel – Bottle Label

SPEARMINT FLAVOR

NDC 055298-013-10

FAST RELIEF

Titralac™

PLUS ANTACID

Simethicone Anti-Gas Formula

Calcium Rich • Sugar Free

Low Aluminum • Very Low Sodium

100 TABLETS 3M

Principal Display Panel – Bottle Label (Tit01 0000 01)

Principal Display Panel – Bottle Label (Tit01 0000 01)

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