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| Product NDC Code | 0135-0642 | ||||
|---|---|---|---|---|---|
| Drug Name | Tums chewy bites orange and cream es |
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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 | 308915, 1044532 |
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| Application Number | M001 | ||||
| Labeler Name | Haleon US Holdings LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (per tablet) Calcium carbonate 750 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. Chew or crush tablets completely before swallowing. 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 alcohol, ammonium hydroxide, beeswax, carnauba wax, citric acid, coconut oil, corn starch, corn syrup, dextrin, ethyl acetate, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6, FD&C yellow no. 6 aluminum lake, flavors, gum arabic, isopropyl alcohol, maltodextrin, methyl paraben, modified starch, n-butyl alcohol, phosphoric acid, propylene glycol, propylparaben, purified water, shellac, sorbic acid, sorbitol, soy lecithin, sucrose, 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 Orange and Cream ES calcium carbonate YELLOW WAX CARNAUBA WAX CITRIC ACID MONOHYDRATE COCONUT OIL STARCH, CORN CORN SYRUP ICODEXTRIN ETHYL ACETATE FD&C BLUE NO. 1 ALUMINUM OXIDE FD&C RED NO. 40 FD&C YELLOW NO. 6 ACACIA ISOPROPYL ALCOHOL MALTODEXTRIN METHYLPARABEN MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) BUTYL ALCOHOL PHOSPHORIC ACID PROPYLENE GLYCOL PROPYLPARABEN WATER SHELLAC SORBIC ACID SORBITOL LECITHIN, SOYBEAN SUCROSE TITANIUM DIOXIDE CORN OIL CALCIUM CARBONATE CALCIUM CATION CARBONATE ION ALCOHOL AMMONIA white T & Cream
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 0135-0642-01 TUMS ® CALCIUM CARBONATE ANTACID Chewy Bites ORANGE & CREAM GOES TO WORK IN SECONDS! LIMITED EDITION EXTRA STRENGTH 750 60 CHEWABLE TABLETS Safety sealed – Do not use if printed inner seal beneath cap is missing or broken. Distributed by: GSK Consumer Healthcare Warren, NJ 07059 Trademarks are owned by or licensed to the GSK group of companies. ©2020 GSK group of companies or its licensor. Front Label: 1001024 Back Label: 1001025 1001024 TUMS Chewy Bites Orange & Cream ES 750 60 ct
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 305 mg 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 or comments? 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