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Topcare antacid calcium - Medication Information

Product NDC Code 36800-468
Drug Name

Topcare antacid calcium

Type Brand
Active Ingredients
Calcium carbonate 750 mg/1
Route ORAL
Dosage Form TABLET, CHEWABLE
RxCUI drug identifier 308915
Application Number M001
Labeler Name Topco Associates LLC
Packages
Package NDC Code Description
36800-468-82 96 tablet, chewable in 1 bottle (36800-468-82)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (per tablet) Calcium Carbonate USP 750mg

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 2-4 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, D&C yellow #10 lake, dextrose, FD&C red #40 lake, FD&C yellow #6 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 CARBONATE ION CALCIUM CATION ADIPIC ACID D&C YELLOW NO. 10 DEXTROSE, UNSPECIFIED FORM FD&C RED NO. 40 FD&C YELLOW NO. 6 MAGNESIUM STEARATE MALTODEXTRIN STARCH, CORN SUCRALOSE L468 banana, orange, pineapple, tropical fruit punch

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 +TopCare ® health TM NDC# 36800-468-82 COMPARE TO EXTRA STRENGTH TUMS® ACTIVE INGREDIENT* EXTRA STRENGTH Antacid Tablets CALCIUM CARBONATE 750 mg FAST RELIEF OF: • Upset Stomach • Heartburn • Acid Indigestion TROPICAL FRUIT FLAVORS QUALITY GUARANTEED GLUTEN FREE 96 CHEWABLE TABLETS K PAREVE Questions? 1-888-423-0139 DISTRIBUTED BY TOPCO ASSOCIATES 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/48ZS0O *This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered trademark, Extra Strength Tums ® . TOPCARE ANTACID CALCIUM CARBONATE TABLETS

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 broken 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 broken 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 10 tablets in 24 hours • if pregnant do not take more than 6 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 300mg • 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 Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product • do not take more than 10 tablets in 24 hours • if pregnant do not take more than 6 tablets in 24 hours • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor 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

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