Mintox
FDA Label NDC 17856-6764

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corp. for the product Mintox (NDC 17856-6764). 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 10 ml), 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.

Label Section Quick Index

Active Ingredients (In Each 10 Ml)

Aluminum hydroxide (equiv. to dried gel, USP) 400 mg

Magnesium hydroxide 400 mg

Simethicone 40 mg

Purpose

Antacid

Antigas

Uses

for the relief of

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
  • pressure and bloating commonly referred to as gas

Ask A Doctor Before Use If You Have

  • kidney disease
  • a magnesium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are

presently taking a prescription drug. Antacids may interact with certain prescription drugs.

When Using This Product

do not take more than 80 mL in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician

Directions

  • shake well before using
  • only use the dose cup provided
  • adults and children 12 years and older: take 10 mL to 20 mL four times a day or as directed by a physician
  • do not take more than 80 mL in 24 hours or use the maximum dosage for more than 2 weeks
  • children under 12 years: consult a physician

Other Information

  • each 10 mL contains: magnesium 175 mg
  • does not meet USP requirements for preservative effectiveness
  • store at 20-25°C (68-77°F)
  • protect from freezing

Inactive Ingredients

butylparaben, flavor, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, peppermint oil, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol, sorbitol solution

Questions Or Comments?

1-800-616-2471

Principal Display Panel

Regluar Strength

Mintox™

Antacid/Antigas

Aluminum Hydroxide ■ Magnesium Hydroxide ■ Simethicone

Fast Relief of:

Heartburn

Acid Indigestion

Pressure and Bloating

Mint Flavor

Compare to the active ingredients of Maalox® Advanced

NDC 17856-6764-01

Image 1 (17856 6764 01)

Image 1 (17856 6764 01)

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