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Product NDC Code | 83335-001 | ||||
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Drug Name | Magnesium oxide |
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Type | Generic | ||||
Pharm Class | Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
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Active Ingredients |
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Route | ORAL | ||||
Dosage Form | TABLET | ||||
RxCUI drug identifier | 198741 | ||||
Application Number | M001 | ||||
Labeler Name | Wittman Pharma, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient (in each tablet) Magnesium Oxide 400 mg (241.3 mg Elemental Magnesium)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Tablet taken Orally Do not take more than 2 tablets in a 24 hour period
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Microcrystaline Cellulose, Sodium Starch Glycolate, Stearic Acid
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.relieves acid indigestion and upset stomach
Purpose
Information about the drug product’s indications for use.Antacid
Spl product data elements
Usually a list of ingredients in a drug product.Magnesium Oxide Magnesium Oxide SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID CELLULOSE, MICROCRYSTALLINE MAGNESIUM OXIDE MAGNESIUM CATION MG White to Off-White Tablet
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Drug Facts ACTIVE INGREDIENT (In each tablet) Magnesium Oxide 400mg (241.3mg elemental magnesium) Purpose Antacid USES relieves - acid indigestion - upset stomach WARNINGS Ask a doctor before use if: You have kidney disease You are taking a prescription drug (antacids may interact with certain prescription drugs). You are pregnant or breast feeding. Do not take more than 2 tablets in a 24 hour period. May have a laxative effect. Keep out of reach of children. DIRECTIONS take one or two antacid tablets daily. Do not exceed two tablets unless directed by a physician. OTHER INFORMATION Magnesium content per tablet: 241.3mg store at room temperature 59°- 86° F (15°- 30°C) INACTIVE INGREDIENTS microcrystalline cellulose, sodium starch, glyocolate, stearic acid Questions? 1-352-549-9917 M-F 9am - 5pm EST Mag Label
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Ask a doctor before use if: * you have kidney disease * you are taking a prescription drug (antacids may interact with certain prescription drugs) * you are pregnant or breast feeding
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API