NDC 0121-1760 Mag-al Liquid

Aluminum Hydroxide And Magnesium Hydroxide

NDC Product Code 0121-1760

NDC CODE: 0121-1760

Proprietary Name: Mag-al Liquid What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Aluminum Hydroxide And Magnesium Hydroxide What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used for a short time to treat occasional constipation. It is a laxative (osmotic-type) that is thought to work by drawing water into the intestines, an effect that helps to cause movement of the intestines. This medication is also used to treat symptoms caused by too much stomach acid such as heartburn, upset stomach, or indigestion. It is an antacid that works by lowering the amount of acid in the stomach.

NDC Code Structure

  • 0121 - Pharmaceutical Associates, Inc.

NDC 0121-1760-30

Package Description: 10 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 30 mL in 1 CUP, UNIT-DOSE

NDC Product Information

Mag-al Liquid with NDC 0121-1760 is a a human over the counter drug product labeled by Pharmaceutical Associates, Inc.. The generic name of Mag-al Liquid is aluminum hydroxide and magnesium hydroxide. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Pharmaceutical Associates, Inc.

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Mag-al Liquid Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ALUMINUM HYDROXIDE 200 mg/5mL
  • MAGNESIUM HYDROXIDE 200 mg/5mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SORBITOL (UNII: 506T60A25R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • CYCLOMETHICONE 4 (UNII: CZ227117JE)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Pharmaceutical Associates, Inc.
Labeler Code: 0121
FDA Application Number: part331 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-14-2004 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Aluminum Hydroxide and Magnesium Hydroxide

Aluminum Hydroxide and Magnesium Hydroxide is pronounced as (a loo' mi num) (hye drox' ide) (mag nee' zhum) (hye drox' ide)

Why is aluminum hydroxide and magnesium hydroxide medication prescribed?
Aluminum Hydroxide, Magnesium Hydroxide are antacids used together to relieve heartburn, acid indigestion, and upset stomach. They may be used to treat these symptoms in ...
[Read More]

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Mag-al Liquid Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

A Sugar-Free AntacidMaalox is a registered trademark of Novartis Consumer Health, Inc.Compare to the active ingredients in Maalox®

R04/14PharmaceuticalAssociated, 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.

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