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| Product NDC Code | 69618-020 | ||||
|---|---|---|---|---|---|
| Drug Name | Calcium carbonate 500 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, CHEWABLE | ||||
| RxCUI drug identifier | 308907 | ||||
| Application Number | part331 | ||||
| Labeler Name | Reliable 1 Laboratories 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 (in each chewable tablet) Calcium carbonate 500 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: chew 2-4 tablets as symptoms occur do not take more than 8 tablets in 24 hours do not use the maximum dosage for more than 2 weeks children under 12 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Al-lakes (D&C red #27, D&C yellow #10, FD&C blue #1, FD&C yellow #6), dextrose, flavors, 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
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.Calcium Carbonate 500 mg Calcium Carbonate FD&C BLUE NO. 1 FD&C YELLOW NO. 6 MAGNESIUM STEARATE D&C YELLOW NO. 10 D&C RED NO. 27 DEXTROSE CALCIUM CARBONATE CALCIUM CATION Light Blue Light Orange Light Yellow assorted fruit AP;043 Light Purple
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.NDC 69618-020-15 *Compare to Active Ingredient of Tums® Regular Strength ASSORTED FLAVORS Calcium Carbonate 500 mg ANTACID 150 CHEWABLE TABLETS *Reliable-1 Laboratories LLC is not affiliated with the owner of the trademark Tums® Calcium Carbonate 500 mg
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.Drug Facts
Other information each tablet contains: calcium 200 mg store at room temperature
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.
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? call 516-341-0666, 8:30 am - 4:30 pm ET, Monday-Friday
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 doctor if symptoms last more than 2 weeks
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 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