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Product NDC Code | 36800-881 | ||||
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Drug Name | Topcare antacid calcium |
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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, CHEWABLE | ||||
RxCUI drug identifier | 308892 | ||||
Application Number | M001 | ||||
Labeler Name | Topco Associates LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (per tablet) Calcium Carbonate USP 1000mg
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 of age and over: chew 2-3 tablets as symptoms occur, or as directed by a doctor • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients adipic acid, dextrose, FD&C blue #1 lake, FD&C red #40 lake, flavors, magnesium stearate, maltodextrin, starch, sucralose.
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 Antacid
Spl product data elements
Usually a list of ingredients in a drug product.Topcare Antacid Calcium calcium carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION ADIPIC ACID DEXTROSE, UNSPECIFIED FORM FD&C BLUE NO. 1 FD&C RED NO. 40 MAGNESIUM STEARATE MALTODEXTRIN STARCH, CORN SUCRALOSE L881 assorted berry
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 +TopCare ® health TM NDC# 36800-881-24 COMPARE TO ULTRA STRENGTH TUMS® ACTIVE INGREDIENT* ULTRA STRENGTH Antacid Tablets CALCIUM CARBONATE 1000 mg OUR PHARMACISTS RECOMMEND FAST RELIEF OF: • Upset Stomach • Heartburn • Acid Indigestion ASSORTED BERRY FLAVORS QUALITY GUARANTEED GLUTEN FREE 72 CHEWABLE TABLETS K PAREVE DISTRIBUTED BY TOPCO ASSOCIATED LLC ELK GROVE VILLAGE, IL 60007 ©TOPCO RARA0918 QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrand.com Visit here for more information: http://topbrnds.com/48ZS23 *This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered trademark, Ultra Strength Tums ® . TOPCARE ANTACID CALCIUM- calcium carbonate tablet, chewable
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 presently taking a prescription drug. Antacids may interact with certain prescription drugs.
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.Do Not Use Do not use if printed seal under cap is torn or missing
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? 1-888-423-0139 Do Not Use Do not use if printed seal under cap is torn or missing
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 this product • do not take more than 7 tablets in 24 hours • if pregnant do not take more than 5 tablets in 24 hours • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor
Storage and handling
Information about safe storage and handling of the drug product.Other information • each tablet contains: elemental calcium 400mg • store at room temperature. Keep the container tightly closed.
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