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Product NDC Code | 49873-403 | ||||
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Drug Name | Inon ace |
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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], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
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Active Ingredients |
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Route | ORAL | ||||
Dosage Form | SOLUTION | ||||
RxCUI drug identifier | 1246297, 1246303 |
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Application Number | M001 | ||||
Labeler Name | Sato Pharmaceutical Co., Ltd. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (in each bottle) Magnesium Aluminosilicate 900 mg Magnesium Hydroxide 250 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.Directions ■ adults and children 12 years and over: Take 1 bottle (30mL) at a time 2 times daily, between meals, or as directed by a doctor. ■ children under 12 years: Ask a doctor. ■ shake well before use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients alcohol, butylparaben, citric acid, flavors (cinnamon oil, fluid extract of ginger root, spearmint oil), hydroxypropylstarch, PEG-60 hydrogenated castor oil, propylparaben, sodium benzoate, sodium citrate, sorbitol, water.
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 these symptoms: ■ heartburn ■ sour stomach ■ acid indigestion
Purpose
Information about the drug product’s indications for use.Purpose Magnesium Aluminosilicate Antacid Magnesium Hydroxide Antacid
Spl product data elements
Usually a list of ingredients in a drug product.Inon Ace magnesium aluminosilicate, magnesium hydroxide ALCOHOL BUTYLPARABEN CITRIC ACID MONOHYDRATE HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) POLYOXYL 60 HYDROGENATED CASTOR OIL PROPYLPARABEN SODIUM BENZOATE SODIUM CITRATE SORBITOL WATER SILODRATE SILODRATE MAGNESIUM HYDROXIDE MAGNESIUM CATION CINNAMON OIL MENTHA OIL GINGER, LIQUID EXTRACT
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.carton
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 or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use this product if you are taking a prescription antibiotic drug containing any form of tetracycline.
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information ■ each bottle contains: sodium 15 mg, magnesium 165 mg
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product ■ do not take more than 2 bottles (adults and children 12 years and over) in a 24-hour period or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician. ■ may have a laxative effect.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
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 Do not use this product if you are taking a prescription antibiotic drug containing any form of tetracycline. Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product ■ do not take more than 2 bottles (adults and children 12 years and over) in a 24-hour period or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician. ■ may have a laxative effect. 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