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Product NDC Code | 84540-422 | ||||
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Drug Name | Na mi cal |
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Type | Brand | ||||
Pharm Class | Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA] |
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Active Ingredients |
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Route | ORAL | ||||
Dosage Form | TABLET | ||||
Application Number | M022 | ||||
Labeler Name | NPG Bio Pharmaceuticals Co.,Ltd. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Calcium Carbonate (CaCO3) 33%, 400 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.Direction Adults and teenagers (18+ years): Take 2 tablets once or twice daily. Children aged 12-18 years: Take 1 tablet once daily. Children aged 8-12 years: Take ½ tablet once daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Microcrystalline Cellulose, Magnesium Oxide, Lactose, Gardenia Florida Fruit Extract, ardenia Jasminoides Fruit Extract, Vitis Vinifera (Grape) Juice Powder, Maltodextrin, Hydroxypropyl, Methylcellulose, Flavor, Ascorbic Acid, Silica, Magnesium Stearate, Cholecalciferol, Zinc Oxide
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 This supplement is intended to support healthy bone development and maintenance in adolescents and adults, and may help prevent osteoporosis.
Purpose
Information about the drug product’s indications for use.Purposes This product is designed to support healthy height growth during the critical years of adolescence, ensuring that young individuals reach their full potential in stature. Additionally, it plays a crucial role in aiding the prevention of osteoporosis by helping to maintain optimal bone density as the body matures, thereby contributing to long-term skeletal health.
Spl product data elements
Usually a list of ingredients in a drug product.Na Mi Cal Calcium Carbonate LACTOSE, UNSPECIFIED FORM CALCIUM CARBONATE CALCIUM CATION WINE GRAPE JUICE ASCORBIC ACID MICROCRYSTALLINE CELLULOSE MAGNESIUM STEARATE MALTODEXTRIN HYDROXYPROPYL CELLULOSE, UNSPECIFIED MAGNESIUM OXIDE CHOLECALCIFEROL SILICON DIOXIDE ZINC OXIDE GARDENIA JASMINOIDES FRUIT METHYLCELLULOSE, UNSPECIFIED 10mm
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.Label NA MI CAL label
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.Warnings Ensure that the included desiccant is not ingested.
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.Warnings Pregnant women are advised to consult with their healthcare provider prior to use.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Warnings Stop use and ask a doctor if symptoms persist or get worse.
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.Warnings When using this product do not use more than directed. take with enough water or drink to avoid getting into airway.
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 Ensure that the included desiccant is not ingested.
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