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Tums - Medication Information

Product NDC Code 0135-0071
Drug Name

Tums

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 500 mg/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 210117,
308907
Application Number M001
Labeler Name Haleon US Holdings LLC
Packages
Package NDC Code Description
0135-0071-27 150 tablet in 1 bottle (0135-0071-27)
0135-0071-48 12 tablet in 1 package (0135-0071-48)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (per tablet) Calcium Carbonate USP 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 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 (assorted fruit) Adipic acid, corn starch, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #5 (tartrazine) lake, FD&C yellow #6 lake, flavors, mineral oil, sodium polyphosphate, sucrose, talc Inactive ingredient (peppermint) corn starch, flavor, mineral oil, sodium polyphosphate, sucrose, talc

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.
TUMS calcium carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION ADIPIC ACID STARCH, CORN FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 MINERAL OIL SODIUM POLYMETAPHOSPHATE SUCROSE TALC orange, yellow, green TUMS assorted fruit, orange, lemon, lime TUMS calcium carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION STARCH, CORN MINERAL OIL SODIUM POLYMETAPHOSPHATE SUCROSE TALC TUMS

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 NDC 0135-0071-27 TUMS ® CALCIUM CARBONATE ANTACID REGULAR STRENGTH 500 Goes to Work in Seconds! Assorted Fruit 150 CHEWABLE TABLETS PAREVE ©2014 GSK Front Label: 103784XA Back Label: 103783XA Tums Regular Assorted Fruit 150 count label Principal Display Panel NDC 0135-0070-27 TUMS ® CALCIUM CARBONATE ANTACID REGULAR STRENGTH 500 Goes to Work in Seconds! Peppermint 150 CHEWABLE TABLETS PAREVE ©2014 GSK Front Label: 103781XA Back Label: 103780XA Tums Regular Peppermint 150 count label

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.
Other information • each tablet contains: elemental calcium 200mg • store below 30 o C (86 o F)

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? 1-800-897-7535 weekdays Safety sealed- Do not use if printed inner seal beneath cap is missing or broken. Gluten-Free www.tums.com GlaxoSmithKline Moon Twp, PA 15108

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 15 tablets in 24 hours • if pregnant do not take more than 10 tablets in 24 hours • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

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. When using this product • do not take more than 15 tablets in 24 hours • if pregnant do not take more than 10 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