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Extra strength - Medication Information

Product NDC Code 51316-021
Drug Name

Extra strength

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]
Active Ingredients
Calcium carbonate 750 mg/1
Route ORAL
Dosage Form TABLET, CHEWABLE
RxCUI drug identifier 308915
Application Number M001
Labeler Name CVS PHARMACY
Packages
Package NDC Code Description
51316-021-96 96 tablet, chewable in 1 bottle (51316-021-96)
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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 swallow tablets whole. 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 D&C Yellow No. 10, dextrose, FD&C Blue No. 1, flavor, 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 sour stomach acid indigestion 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.
Extra Strength Antacid Tablets D&C YELLOW NO. 10 DEXTROSE, UNSPECIFIED FORM FD&C BLUE NO. 1 MAGNESIUM STEARATE MALTODEXTRIN STARCH, CORN SUCRALOSE CALCIUM CARBONATE CALCIUM CATION CARBONATE ION RP102

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 NDC# 51316-021-96 *Compare to the active ingredient in Extra Strength Tums® EXTRA STRENGTH Antacid Tablets Calcium Carbonate 750 mg Fast Relief of Upset Stomach, Heartburn and Acid Indigestion Wintergreen Naturally and Artificially Flavored 96 Chewable Tablets GLUTEN FREE 100% Satisfaction Guaranteed! K PAREVE Distributed by: *This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered trademark, Extra Strength Tums ® CVS Extra Strength Antacid Calcium Carbonate 96 Chewable 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.

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? 1-866-467-2748

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: calcium 300mg store at room temperature. Keep the container tightly closed DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

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