Mag-al Liquid Suspension
FDA Label NDC 0121-1760

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pai Holdings, Llc for the product Mag-al Liquid (NDC 0121-1760). 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 other, otc - purpose, inactive ingredients, indications, directions, warnings, otc - keep out of reach of children, drug interaction precaution, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

A Sugar-Free Antacid

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

Compare to the active ingredients in Maalox®

R04/14

Pharmaceutical
Associated, Inc.
Greenville, SC 29605

Otc - Purpose

Each 5 mL (teaspoonful) contains 200 mg aluminum hydroxide (equiv. to dried gel, USP) and 200 mg magnesium hydroxide and provides approximately 9 mEq of acid-neutralizing capacity (ANC).

Inactive Ingredients

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

Sodium content: 4 mg/5 mL

Indications

As an antacid for symptomatic relief of hyperacidity associated with the diagnosis of peptic ulcer, gastritis, peptic esophagitis, gastric hyperacidity, or hiatal hernia.

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.

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.

Otc - Keep Out Of Reach Of Children

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

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.

How Supplied

White colored, peppermint flavored liquid supplied in the following oral dosage form: NDC 0121-1760-30 (unit dose cups of 30 mL, 10 × 10's).

Storage

Keep tightly closed. Store at controlled room temperature, 20° to 25°C (68° to 77°F) [See USP]. Protect from freezing.

Principal Display Panel - 30 Ml Cup Label

Delivers 30 mL
NDC 0121-1760-30

MAG-AL LIQUID

EACH 30 mL Contains:
Magnesium Hydroxide 1200 mg
Aluminum Hydroxide 1200 mg

SHAKE WELL

FOR INSTITUTIONAL USE ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT

F17603000

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