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| Product NDC Code | 58657-120 | ||||
|---|---|---|---|---|---|
| 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 | Method Pharmaceuticals, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient 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.Directions take one or two antacid tablets daily. Do not exceed two tablets unless directed by a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Croscarmellose Sodium, Microcrystalline Cellulose, Silicon Dioxide, and 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.Use relieves: ■ acid indigestion ■ upset stomach
Purpose
Information about the drug product’s indications for use.Purpose Antacid
Spl product data elements
Usually a list of ingredients in a drug product.Magnesium Oxide Magnesium Oxide CROSCARMELLOSE SODIUM CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE STEARIC ACID MAGNESIUM OXIDE MAGNESIUM CATION 120
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.Principal Display Panel NDC 58657-120-12 Magnesium Oxide 400 mg 241.3 Elemental Magnesium Antacid 120 Tablets label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call Method at 1-877-250-3427 or FDA at 1-800-FDA-1088 Manufactured for: Method Pharmaceuticals, LLC Fort Worth, Texas 76118 Rev. 04/18
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at controlled room temperature 15° to 30°C (59° to 86°F). Tamper evident, do not use if imprinted safety seal under cap is broken or missing.
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.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.
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