Label: MAG-AL PLUS- magnesium hydroxide, aluminum hydroxide and dimethicone liquid
- NDC Code(s): 55154-9429-5
- Packager: Cardinal Health
- This is a repackaged label.
- Source NDC Code(s): 0121-1761
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- 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 mgClose
- 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.Close
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.Close
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.Close
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.Close
- Inactive ingredients
Butylparaben, hydroxypropyl methylcellulose, flavoring, propylene glycol, propylparaben, purified water, sodium saccharin, and sorbitol solution.
Sodium content: 4 mg/5 mlClose
Keep tightly closed. Store at Controlled Room Temperature, 20-25 C (68-77 F). [See USP]. Protect from freezing.Close
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
*Compare to the active ingredients in Maalox®
*Maalox is a registered trademark of Novartis Consumer Health, Inc.
- Principal Display Panel
5 Unit Dose Cups
- INGREDIENTS AND APPEARANCE
magnesium hydroxide, aluminum hydroxide, simethicone liquid
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55154-9429(NDC:0121-1761) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM HYDROXIDE (MAGNESIUM HYDROXIDE) MAGNESIUM HYDROXIDE 1200 mg in 30 mL ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE 1200 mg in 30 mL DIMETHICONE (DIMETHICONE) DIMETHICONE 120 mg in 30 mL Inactive Ingredients Ingredient Name Strength BUTYLPARABEN HYPROMELLOSES PROPYLENE GLYCOL PROPYLPARABEN WATER SACCHARIN SODIUM SORBITOL Product Characteristics Color WHITE Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55154-9429-5 5 in 1 BAG 1 30 mL in 1 CUP, UNIT-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 06/07/2011 Labeler - Cardinal Health (188557102) Establishment Name Address ID/FEI Business Operations Cardinal Health 188557102 REPACK