FDA Label for Mag-al Plus
View Indications, Usage & Precautions
Mag-al Plus Product Label
The following document was submitted to the FDA by the labeler of this product Pai Holdings, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Antacid/Anti-Gas
Sugar-Free
Maalox is a registered trademark of Novartis Consumer Health, Inc. Compare to the active ingredients in Maalox® |
R04/14
Pharmaceutical
Associates, Inc.
Greenville, SC 29605
Description
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).
Inactive Ingredients
Butylparaben, hydroxypropyl methylcellulose, flavoring, propylene glycol, propylparaben, purified water, sodium saccharin, and sorbitol solution.
Sodium content: 4 mg/5 mL
Indications & Usage
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.
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 0121-1761-30 (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 Unit-Dose Cup
Delivers 30 mL
NDC 0121-1761-30
MAG-AL Plus
EACH 30 mL Contains:
Magnesium Hydroxide 1200 mg
Aluminum Hydroxide 1200 mg
Simethicone 120 mg
SHAKE WELL
FOR INSTITUTIONAL USE ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT
F17613000
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