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| Product NDC Code | 0135-0606 | ||||||||||||||
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| Drug Name | Tums chewy bites |
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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 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. Crush or chew 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 acacia, beeswax, carmine, carnauba wax, citric acid, coconut oil, corn starch, corn syrup, dextrin, FD&C blue no. 2 aluminum lake, FD&C red no. 40, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 aluminum lake (tartrazine), maltodextrin, medium chain triglycerides, methylparaben, natural and artificial flavors, pharmaceutical ink, phosphoric acid, povidone, propylene glycol, propylparaben, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, triacetin, vegetable oil
Inactive ingredients
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 CALCIUM CARBONATE CALCIUM CATION CARBONATE ION ACACIA ALCOHOL AMMONIA YELLOW WAX MEDIUM-CHAIN TRIGLYCERIDES CARMINIC ACID CARNAUBA WAX CITRIC ACID MONOHYDRATE COCONUT OIL STARCH, CORN CORN SYRUP STARCH, WHEAT ETHYL ACETATE FD&C BLUE NO. 1 ALUMINUM LAKE FD&C BLUE NO. 2 ALUMINUM LAKE FD&C RED NO. 40 FD&C RED NO. 40 ALUMINUM LAKE FD&C YELLOW NO. 5 ALUMINUM LAKE FD&C YELLOW NO. 6 FD&C YELLOW NO. 6 ALUMINUM LAKE ISOPROPYL ALCOHOL MALTODEXTRIN METHYLPARABEN MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) BUTYL ALCOHOL PHOSPHORIC ACID POVIDONE, UNSPECIFIED PROPYLENE GLYCOL PROPYLPARABEN WATER SHELLAC SODIUM BENZOATE SORBIC ACID SORBITOL SOYBEAN SOYBEAN LECITHIN SUCROSE TERT-BUTYLHYDROQUINONE TITANIUM DIOXIDE TRIACETIN CORN OIL red, pink, purple T Assorted Berry: Strawberry, Raspberry, Mixed Berry
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 (108 ct. Bottle) GOES TO WORK IN SECONDS! CALCIUM CARBONATE TUMS ANTACID Chewy Bites Assorted Berries EXTRA STRENGTH 750 108 CHEWABLE TABLETS Tums Chewy Bites Asst Berries 108 Tablets
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) • contains FD&C Yellow No. 5 (tartrazine) as a color additive
Generic Section (Bottles) Safety sealed – Do not use if printed inner safety seal under cap is broken or missing.
Generic Section (2 ct. Pouch) Safety sealed – Do not use if pouch is open or torn.
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? 1-800-897-7535
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