Alumox
FDA Label NDC 53041-152

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Guardian Drug Company for the product Alumox (NDC 53041-152). 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 tablet), purpose, uses, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, do not take, 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 Tablet)

Aluminum hydroxide (equiv. to dried gel, USP) 200 mg

Magnesium hydroxide 200 mg

Simethicone 25 mg

Purpose

Antacid

Antacid

Antigas

Uses

relieves:

acid indigestion

heartburn

sour stomach

upset stomach & gas associated with these symptoms

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 certain prescription drugs.

Do Not Take

more than 16 tablets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

keep out of reach of children. In case of overdose get medical help or contact a poison control center immediately.

Directions

  • chew 1 to 4 tablets 4 times a day or as directed by a doctor.

Other Information

  • each tablet contains: magnesium 85 mg
  • do not use if seal under cap is torn or missing
  • store at room temperature
  • keep tightly closed and dry

Inactive Ingredients

citric acid anhydrous, corn starch, D&C red 30 lake, D&C yellow 10 lake, dextrose, flavor, glycerin, magnesium stearate, maltodextrin, mannitol, pregelatinized starch, saccharin sodium, sorbitol, sugar

Pdp

Alumox

Antacid+Antigas

Lemon Flavor

Aluminum Hydroxide / Antacid

Magnesium Hydroxide / Antacid

Simethicone / Antigas

FOR FAST RELIEF OF:

Acid indigestion

Sour stomach

Heartburn

Gas

100 Chewable Tablets

Sn (Gdc152)

Sn (Gdc152)

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