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Product NDC Code | 10135-721 | ||||
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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 | 311430 | ||||
Application Number | M001 | ||||
Labeler Name | Marlex Pharmaceuticals 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 420 mg
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.Supplement Facts Serving Size 1 Tablet Magnesium (as Magnesium Oxide) Amount per Serving 253mg % Daily value 63%
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other Ingredients Colloidal silicon dioxide, Croscarmellose sodium, microcrystalline cellulose, stearic acid Magnesium oxide may help with magnesium deficiencies.*
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.SUGGESTED USE As a dietary supplements, adult take one (1) tablet daily preferably with food or as directed by your healthcare practitioner.
Purpose
Information about the drug product’s indications for use.Purpose Dietary Supplement
Spl product data elements
Usually a list of ingredients in a drug product.magnesium oxide magnesium oxide MICROCRYSTALLINE CELLULOSE STEARIC ACID SILICON DIOXIDE CROSCARMELLOSE SODIUM MAGNESIUM OXIDE MAGNESIUM CATION
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 10135-0721-01 Magnesium Oxide 420 mg 100 TABLETS 721-01
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.Store in a cool, dry place.
* These statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
Manufactured for/ Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720 Rev.1 10/23 AA
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.CAUTIONS If you are pregnant, nursing, taking any medications or have any medical condition, consult your doctor before use. If you have any kidney disease, take only under the supervision of a doctor. Discontinue use and consult your doctor if any adverse reactions occur. Keep out of reach of children.
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
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