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| Product NDC Code | 43353-958 | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Rugby calcium carbonate 10 gr |
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| Type | Brand | ||||||||||||||||
| Pharm Class | Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||||||||||||||
| Dosage Form | TABLET, CHEWABLE | ||||||||||||||||
| Application Number | part331 | ||||||||||||||||
| Labeler Name | Aphena Pharma Solutions - Tennessee, LLC | ||||||||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Calcium carbonate 10 gr (648 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 take one to four tablets daily do not take more than 4 tablets in 24 hours do not use the maximum dosage for more than 2 weeks
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients corn starch, crospovidone, magnesium stearate, maltodextrin
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: acid indigestion heartburn sour stomach acid indigestion upset stomach associated with these symptoms
Purpose
Information about the drug product’s indications for use.Purpose Antacid
Spl product data elements
Usually a list of ingredients in a drug product.Rugby Calcium Carbonate 10 gr Antacid Tablets CALCIUM CARBONATE CALCIUM CATION STARCH, CORN MAGNESIUM STEARATE MALTODEXTRIN RP106
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 - 648mg NDC 43353-958 - Calcium Carbonate 648mg - Rx Only Bottle Label 648mg
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.Other Information each tablet contains: calcium 260mg store at room temperature 15 0 -30 0 C (59 0 -86 0 F)
Repackaging Information This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 648mg 30 43353-958-30 60 43353-958-53 90 43353-958-60 100 43353-958-65 180 43353-958-80 200 43353-958-85 270 43353-958-92 Store between 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20160606DH Aphena Pharma Solutions - TN
| Count | |
| 30 | 43353-958-30 |
| 60 | 43353-958-53 |
| 90 | 43353-958-60 |
| 100 | 43353-958-65 |
| 180 | 43353-958-80 |
| 200 | 43353-958-85 |
| 270 | 43353-958-92 |
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
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments 1-800-645-2158
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 or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. Stop use and ask a doctor is 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