Aluminum Hydroxide And Magnesium Carbonate Tablet, Chewable
FDA Label NDC 76457-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Simpex Pharma Pvt. Ltd for the product Aluminum Hydroxide And Magnesium Carbonate (NDC 76457-001). 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 (in each tablet), purpose, uses, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient (In Each Tablet)

Aluminum hydroxide, 160 mg

Magnesium carbonate, 105 mg

Purpose

Antacid

Uses

Relieves acid indigestion leading to

  • stomach upset
  • heart burn

Ask A Doctor Before Use If You Have

  • kidney disease
  • a magnesium or sodium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are

  • now taking a prescription drug. Antacids may interact with certain prescription drugs.

When Using This Product

do not take more than 16 tablets in a 24-hour period or use the maximum dosage for more than 2 weeks

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 50 mg and sodium 32 mg
  • store at 20°-25°C

Inactive Ingredients

alginic acid, calcium stearate, color red iron oxide, flavor (mint), maize starch, magnesium oxide, mannitol, sodium bicarbonate, sucrose

Package Labeling:

Label (Label)

Label (Label)

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