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| Product NDC Code | 48433-106 | ||||
|---|---|---|---|---|---|
| Drug Name | Calcium antacid |
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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 | Safecor Health, 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 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 • chew 2-4 tablets as symptoms occur, repeat hourly if needed Other Information • store at 59°-86°F • do not use if imprinted safety seal under cap is broken or missing • Calcium content per tablet: 200mg Supplement Facts • Serving size 2 tablets • Servings per Container: 50 • Amount Per Serving Calories: 5 Calcium: 400mg(40%DV)
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Blue #1, dextrose, flavors, magnesium stearate, maltodextrin, red #40, yellow #6, yellow #10 Packaged and Distributed by: Safecor Health, LLC 317 New Boston Street, Suite 100 Woburn, MA 01801
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 • heartburn • acid indigestion • sour stomach • upset stomach associated with these symptoms
Purpose
Information about the drug product’s indications for use.Purpose Acid Indigestion, Heartburn, Sour & Upset Stomach
Spl product data elements
Usually a list of ingredients in a drug product.Calcium Antacid Calcium Carbonate CALCIUM CARBONATE CALCIUM CATION FD&C BLUE NO. 1 DEXTROSE MAGNESIUM STEARATE MALTODEXTRIN FD&C RED NO. 40 FD&C YELLOW NO. 6 D&C YELLOW NO. 10 AZ;024
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.Package/Label Principal Display Panel SAFECOR HEALTH CALCIUM ANTACID Regular Strength 500 mg NDC 48433-106-01 Fruit Flavored Chewable Tablets Compare to Tums ® Active Ingredient * This package is not child resistant. For institutional use only. This product is not manufactured or distributed by GlaxoSmithKline, distributor of Tums® Questions or comments? Call 1-800-447-1006 100 Unit Dose Chewable Tablets Calcium Antacid 500 mg Unit Dose Box Label
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. When Using do not take more than 15 tablets in a 24 hour period or use the maximum dosage of this product for more than two weeks.
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
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.When Using do not take more than 15 tablets in a 24 hour period or use the maximum dosage of this product for more than two 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
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