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Product NDC Code | 70369-004 | ||||
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Drug Name | Calcium carbonate 10 gr (648 mg) |
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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 | ||||
RxCUI drug identifier | 577040 | ||||
Application Number | part331 | ||||
Labeler Name | CitraGen Pharmaceuticals, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active ingredient (in each tablet) 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 Hydrogenated Vegetable Oil, Maltodextrin and Microcrystalline Cellulose
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 upset stomach associated with these symptoms
Purpose
Information about the drug product’s indications for use.Purpose Antacid / Calcium Supplement
Spl product data elements
Usually a list of ingredients in a drug product.Calcium Carbonate 10 gr (648 mg) Calcium Carbonate CALCIUM CARBONATE CALCIUM CATION HYDROGENATED COTTONSEED OIL MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE CG004
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.CitraGen Pharmaceuticals, Inc. NDC: 70369-004-01 Calcium Carbonate Tablets, USP 10 gr (648 mg) ANTACID / Calcium Supplement 1000 Tablets THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN 70369-004-01_Bottle_Label
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.TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Manufactured by: CitraGen Pharmaceuticals, Inc., Fremont, CA 94538. www.citragenpharma.com Rev. 07/18 R-00
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.
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 tablet contains : Calcium 260 mg store at room temperature 15º - 30º C (59º - 86º F)
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? Phone: +1-510-249-9066 (9AM-5PM PST, Mon-Fri); e-mail: [email protected]
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.Stop use and ask a doctor if symptoms last more than 2 weeks.
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 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