Mag-Al Plus

Cardinal Health

Mag-Al Plus

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient
• Purpose
• Keep Out of Reach of Children
• Mag-Al Plus Uses
• Warnings
• Directions
• Inactive ingredients
• Storage
• Other
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient

Delivers 30 mL

Each 5 mL (teaspoonful) contains 200 mg Aluminum Hydroxide (equiv. to dried gel, USP), 200 mg Magnesium Hydroxide and 20 mg simethicone and provides approximately 9 mEq of acid-neutralizing capacity (ANC).

Each 30 mL Contains:

Magnesium Hydroxide 1200 mg

Aluminum Hydroxide 1200 mg

Simethicone 120 mg

Purpose

Antacid/Anti-Gas

Sugar Free

Keep Out of Reach of Children

This package is intended for institutional use only. Keep this and all drugs out of the reach of children.

Mag-Al Plus Uses

Indications: As an antacid for symptomatic relief of hyperacidity associated with the diagnosis of peptic ulcer, gastritis, peptic esophagitis, gastric hyperacidity, or hiatal hernia. As an antiflatulent to alleviate the symptoms of gas, including postoperative gas pain.

Warnings

The maximum recommended daily dosage of this product is 80 ml (16 teaspoonfuls). Do not take more than this dosage in a 24-hour period or use this dosage for more than 2 weeks except under the advice and supervision of a physician. Do not use this product except under the advice and supervision of a physician if you have kidney disease. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

Prolonged use of aluminum-containing antacids in patients with renal failure may result in or worsen dialysis osteomalacia. Elevated tissue aluminum levels contribute to the development of the dialysis encephalopathy and osteomalacia syndromes. Small amounts of aluminum are absorbed from the gastrointestinal tract and renal excretion of aluminum is impaired in renal failure. Aluminum is not well removed by dialysis because it is bound to albumin and transferrin, which do not cross dialysis membranes. As a result, aluminum is deposited in bone, and dialysis osteomalacia may develop when large amounts of aluminum are ingested orally by patients with impaired renal function.

Aluminum forms insoluble complexes with phosphate in the gastrointestinal tract, thus decreasing phosphate absorption. Prolonged use of aluminum-containing antacids by normophosphatemic patients may result in hypophosphatemia if phosphate intake is not adequate. In its more severe forms, hypophosphatemia can lead to anorexia, malaise, muscle weakness, and osteomalacia.

Drug Interaction Precaution:

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

Directions

Shake well before using. Adults and children 12 years and older: 10 ml to 20 ml (2 to 4 teaspoonfuls) four times a day or as directed by a physician. Children under 12 years: consult a physician.

Inactive ingredients

Sugar Free

Butylparaben, hydroxypropyl methylcellulose, flavoring, propylene glycol, propylparaben, purified water, sodium saccharin, and sorbitol solution.

Sodium content: 4 mg/5 ml

Storage

Keep tightly closed. Store at Controlled Room Temperature, 20-25 C (68-77 F). [See USP]. Protect from freezing.

Other

How Supplied: White colored, peppermint flavored liquid supplied in the following oral dosage form: NDC 0121-1761-30 (unit dose cups of 30 mL, 10 x 10's).

Pharmaceutical Associates, Inc.

Subsidiary of Beach Products, Inc.

201 Delaware Street

Greenville, SC 29605

(800) 845-8210

www.paipharma.com

*Compare to the active ingredients in Maalox®

*Maalox is a registered trademark of Novartis Consumer Health, Inc.

R12/03

Principal Display Panel

Mag-Al Plus

5 Unit Dose Cups