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Product NDC Code | 84540-522 | ||||
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Drug Name | R cos |
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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) 18%...............180 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 For teenagers and adults (18+ years): Take 2 tablets once or twice daily. For children aged 12-18 years: Take 1 tablet once daily. For 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, Lactose, Magnesium Oxide, Gardenia Florida Fruit Extract,Gardenia Jasminoides Fruit Extract, Maltodextrin, L-Phenylalanine, L-Leucine, L-Methionine, L-Lysine Hydrochloride, Palatinose, L-Isoleucine,Leucine,Isoleucine,Valine Ascorbic Acid, Vitis Vinifera (Grape) Juice Powder, Flavor Cyanocobalamin, Hydroxypropyl Methylcellulose, Phytonadione Zinc Oxide, Corn Starch, Panax Ginseng Root Powder. Silica Cholecalciferol, Silk Extract, Cordyceps Sinensis Extract, Nelumbo Nucifera (Lotus) Leaf Powder
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 A dietary supplement to support the immune system and help alleviate symptoms associated with various viral and bacterial infections, such as those caused by COVID-19 and MERS. Depending on the stmptoms, it may be taken alongside antipyretics, expectorants, and analgesics.
Purpose
Information about the drug product’s indications for use.Purposes This supplement may support the immune system and help alleviate symptoms associated with various viral and bacterial infections, such as those caused by COVID-19 and MERS. Depending on the symptoms, it may be taken alongside antipyretics, expectorants, and analgesics.
Spl product data elements
Usually a list of ingredients in a drug product.R Cos Calcium Carbonate OPHIOCORDYCEPS SINENSIS GARDENIA JASMINOIDES FRUIT MALTODEXTRIN LYSINE HYDROCHLORIDE VALINE LACTOSE, UNSPECIFIED FORM BOMBYX MORI FIBER MAGNESIUM OXIDE METHIONINE WINE GRAPE JUICE CYANOCOBALAMIN ZINC OXIDE STARCH, CORN CALCIUM CARBONATE CALCIUM CATION ISOMALTULOSE ANHYDROUS ISOLEUCINE PHYTONADIONE NELUMBO NUCIFERA LEAF ASCORBIC ACID CHOLECALCIFEROL PHENYLALANINE ASIAN GINSENG LEUCINE MICROCRYSTALLINE CELLULOSE HYPROMELLOSES SILICON DIOXIDE
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 84540-502R Cos 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 Do not use if you are sensitive to any of the ingredients in this product. Consult a healthcare professional before use if you are pregnant or breastfeeding. Do not exceed the recommended dosage. Swallow with sufficient water or a beverage to prevent aspiration.
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 Keep out of reach of children 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