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Mag-AL Plus XS by Pharmaceutical Associates, Inc.

Dosage form: suspension
Ingredients: Aluminum Hydroxide 400mg in 5mL, Magnesium Hydroxide 400mg in 5mL, Dimethicone 40mg in 5mL
Labeler: Pharmaceutical Associates, Inc.
NDC Code: 0121-1762

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Mag-AL Plus
XS

Maximum Strength Antacid/Anti-Gas
Sugar-Free

Maalox is a registered trademark of Novartis Consumer Health, Inc.
Compare to the active ingredients in Maalox®

DESCRIPTION

Each 5 mL (teaspoonful) contains 400 mg aluminum hydroxide (equiv. to dried gel, USP), 400 mg magnesium hydroxide and 40 mg simethicone and provides approximately 18 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

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 60 mL (12 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.

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, cherry flavored liquid supplied in the following oral dosage form: NDC 0121-1762-30 (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.

R04/14

Pharmaceutical
Associates, Inc.
Greenville, SC 29605

PRINCIPAL DISPLAY PANEL - 30 mL Cup Label

Delivers 30 mL
NDC 0121-1762-30

MAG-AL Plus XS

EACH 30 mL Contains:
Magnesium Hydroxide 2400 mg
Aluminum Hydroxide 2400 mg
Simethicone 240 mg

SHAKE WELL

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

MAG-AL PLUS   XS
aluminum hydroxide, magnesium hydroxide, and dimethicone suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1762
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aluminum Hydroxide (Aluminum Hydroxide) Aluminum Hydroxide400 mg  in 5 mL
Magnesium Hydroxide (Magnesium Cation and Hydroxide Ion) Magnesium Hydroxide400 mg  in 5 mL
Dimethicone (Dimethicone) Dimethicone40 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Butylparaben 
Propylparaben 
Hypromellose 2910 (4000 mpa.s) 
Propylene Glycol 
Sorbitol 
Saccharin Sodium 
Peppermint Oil 
Cyclomethicone 4 
Water 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0121-1762-3010 TRAY in 1 CASE
110 CUP, UNIT-DOSE in 1 TRAY
130 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33101/14/2004
Labeler - Pharmaceutical Associates, Inc. (044940096)
Establishment
NameAddressID/FEIOperations
Pharmaceutical Associates, Inc.097630693MANUFACTURE(0121-1762)

Revised: 09/2014
 
Pharmaceutical Associates, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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