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Product NDC Code | 71205-515 | ||||||
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Drug Name | Mintox maximum strength |
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Type | Brand | ||||||
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], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
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Active Ingredients |
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Route | ORAL | ||||||
Dosage Form | SUSPENSION | ||||||
RxCUI drug identifier | 237870, 708127 |
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Application Number | M001 | ||||||
Labeler Name | Proficient Rx LP | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (in each 5 mL teaspoonful) Aluminum hydroxide 400 mg (equivalent to dried gel, USP) Magnesium hydroxide 400 mg Simethicone 40mg
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 • shake well before using • adults and children 12 years and older: take 2 to 4 teaspoonfuls two times a day or as directed by a physician • do not take more than 8 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks. • children under 12 years: consult a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzyl alcohol, butylparaben, caramel color, carboxymethylcellulose sodium, D and C yellow no.10, flavor, glycerin, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution
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.Uses relieves • heartburn • sour stomach • acid indigestion • the symptoms referred to as gas
Purpose
Information about the drug product’s indications for use.Purposes Antacid Antigas
Spl product data elements
Usually a list of ingredients in a drug product.MINTOX MAXIMUM STRENGTH aluminum hydroxide, magnesium hydroxide, dimethicone ALUMINUM HYDROXIDE ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE MAGNESIUM CATION HYDROXIDE ION DIMETHICONE DIMETHICONE BENZYL ALCOHOL BUTYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE PROPYLPARABEN WATER SACCHARIN SODIUM SORBITOL D&C YELLOW NO. 10 GLYCERIN lemon
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.package Label NDC 71205-515-35 Mintox Maximum Strength antacid/antigas Alumina, Magnesia and Simethicone Oral Suspension USP Fast Relief of: HEARTBURN ACID INDIGESTION PRESSURE AND BLOATING Lemon Creme *compare to the active ingredients of Maalox Advanced Maximum Strength 12 FL OZ (355 mL) 71205-515-35
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information • each 5 mL teaspoonful contains: magnesium 165 mg, sodium 5 mg • keep tightly closed • store at room temperature and avoid freezing
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 • a magnesium-restricted diet Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. Stop use and ask a doctor if symptoms last more than 2 weeks If pregnant or breast-feeding, ask a health professional before use. 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