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Tums chewy bites - Medication Information

Product NDC Code 67751-191
Drug Name

Tums chewy bites

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,
1044532
Application Number M001
Labeler Name Navajo Manufacturing Company Inc.
Packages
Package NDC Code Description
67751-191-01 1 pouch in 1 carton (67751-191-01) / 2 tablet, chewable in 1 pouch
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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.
Acacia gum, alcohol, ammonium hydroxide, beeswax, carmine, carnauba wax, citric acid, coconut oil, corn starch, corn syrup, dextrin, ethyl acetate, ethyl alcohol, FD&C blue #1 alum lake, FD&C blue #2 alum lake, FD&C red #40 alum lake, FD&C yellow #6 alum lake, flavors, gum arabic, isopropyl alcohol, maltodextrin, methylparaben, n-butyl alcohol, phosphoric acid, propylparaben, propylene glycol, purified water, shellac, sorbic acid, sorbitol, soybean oil, soy lecithin, sucrose, TBHQ, titanium dioxide, vegetable oil

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 Chewy Bites calcium carbonate ACACIA ALCOHOL AMMONIA YELLOW WAX CARMINIC ACID CARNAUBA WAX CITRIC ACID MONOHYDRATE COCONUT OIL STARCH, CORN CORN SYRUP ICODEXTRIN ETHYL ACETATE FD&C BLUE NO. 1 ALUMINUM OXIDE FD&C BLUE NO. 2 FD&C RED NO. 40 FD&C YELLOW NO. 6 ISOPROPYL ALCOHOL MALTODEXTRIN METHYLPARABEN BUTYL ALCOHOL PHOSPHORIC ACID PROPYLPARABEN PROPYLENE GLYCOL WATER SHELLAC SORBIC ACID SORBITOL SOYBEAN OIL LECITHIN, SOYBEAN SUCROSE TERT-BUTYLHYDROQUINONE TITANIUM DIOXIDE CORN OIL CALCIUM CARBONATE CALCIUM CATION CARBONATE ION T Mixed berry: Raspberry and Blueberry

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 Handy Solutions® Guarantee If dissatisfied with this product, return it with a brief explanation to 5330 Fox Street, Denver, CO 80216. We'll replace it free of charge and refund your postage. You may also call 1-800-525-5097 for customer service, 9am to 4pm MST, weekdays or email us at [email protected]. Visit us on the web at www.navajoinc.com Packaged and Distributed by Navajo Mfg. Co. Inc. with permission of GSK Consumer Healthcare ©2019 GSK group of companies or its licensor. All rights reserved. Tums Chewy Bites

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 chewable tablet contains: elemental calcium 300mg do not store above 25°C (77°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 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? Call 1-800-897-7535

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 6 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

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 6 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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