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| Product NDC Code | 0135-0074 | ||||||||||||||||||||
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| Drug Name | Tums ex |
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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 | ||||||||||||||||||||
| 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 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 (Assorted Fruit) adipic acid, corn starch, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 aluminum lake (tartrazine), FD&C yellow no. 6 aluminum lake, flavors, mineral oil, sodium polyphosphate, sucrose, talc
Inactive ingredients (Assorted Berries) adipic acid, corn starch, FD&C blue #1 lake, FD&C red #40 lake, flavors, mineral oil, sodium polyphosphate, sucrose, talc
Inactive ingredients (Sugar Free Orange Cream) acacia, adipic acid, aspartame, calcium stearate, FD&C yellow #6 lake, flavors, sorbitol
Inactive ingredient (Assorted Tropical Fruit) corn starch, FD&C red #40 lake, FD&C yellow #5 (tartrazine) lake, FD&C yellow #6 lake, flavors, mineral oil, sodium polyphosphate, sucrose, talc
Inactive ingredients (Wintergreen) corn starch, FD&C blue #1 lake, FD&C yellow #5 (tartrazine) lake, flavor, mineral oil, sodium polyphosphate, sucrose, talc
Inactive ingredients (Cherry) adipic acid, corn starch, FD&C red #40 lake, 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 EX calcium carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION ADIPIC ACID STARCH, CORN FD&C BLUE NO. 1 ALUMINUM OXIDE FD&C RED NO. 40 FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 MINERAL OIL SODIUM POLYMETAPHOSPHATE SUCROSE TALC TUMS Assorted fruit flavor, orange, lemon, lime TUMS EX calcium carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION ADIPIC ACID STARCH, CORN FD&C BLUE NO. 1 ALUMINUM OXIDE FD&C RED NO. 40 MINERAL OIL SODIUM POLYMETAPHOSPHATE SUCROSE TALC mauve bluish TUMS Assorted Berry, raspberry, mixed berry TUMS EX calcium carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION ACACIA ADIPIC ACID ASPARTAME CALCIUM STEARATE FD&C YELLOW NO. 6 ALUMINUM OXIDE SORBITOL orange cream TUMS;FREE ORANGE CREAM TUMS EX calcium carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION STARCH, CORN FD&C RED NO. 40 ALUMINUM OXIDE FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 MINERAL OIL SODIUM POLYMETAPHOSPHATE SUCROSE TALC red-orange cream light yellow TUMS Assorted tropical fruit flavor, tropical punch, mandarin orange, orange-pineapple, strawberry-banana TUMS EX calcium carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION STARCH, CORN FD&C BLUE NO. 1 ALUMINUM OXIDE FD&C YELLOW NO. 5 MINERAL OIL SODIUM POLYMETAPHOSPHATE SUCROSE TALC TUMS TUMS EX calcium carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION ADIPIC ACID STARCH, CORN FD&C RED NO. 40 ALUMINUM OXIDE 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 (Assorted Fruit) GOES TO WORK IN SECONDS! CALCIUM CARBONATE TUMS ANTACID Assorted Fruit 96 CHEWABLE TABLETS EXTRA STRENGTH 750 Tums EX Asst Fruit 96 tablets
Principal Display Panel (Assorted Berries) GOES TO WORK IN SECONDS! CALCIUM CARBONATE TUMS ANTACID Assorted Berries 96 CHEWABLE TABLETS EXTRA STRENGTH 750 Tums EX Asst Berries 96 tablets
Principal Display Panel NDC 0135-0154-05 TUMS ® CALCIUM CARBONATE ANTACID Sugar-Free Orange EXTRA STRENGTH 750 80 CHEWABLE TABLETS GOES TO WORK IN SECONDS! PAREVE ©2014 GSK Front Label: 103720XA Back Label: 103719XA Tums Extra Strength Sugar Free Orange 80 count front label
Principal Display Panel NDC 0135-0140-03 TUMS ® CALCIUM CARBONATE ANTACID Tropical Fruit EXTRA STRENGTH 750 96 CHEWABLE TABLETS GOES TO WORK IN SECONDS! PAREVE ©2014 GSK Front Label: 103704XA Back Label: 103705XA Tums Extra Strength Tropical Fruit 96 count front label
Principal Display Panel NDC 0135-0076-25 TUMS ® CALCIUM CARBONATE ANTACID Wintergreen EXTRA STRENGTH 750 96 CHEWABLE TABLETS GOES TO WORK IN SECONDS! PAREVE ©2014 GSK Front Label: 103707XA Back Label: 103708XA Tums Extra Strength Wintergreen 96 count front label
Principal Display Panel NDC 0135-0521-02 TUMS ® CALCIUM CARBONATE ANTACID Cherry EXTRA STRENGTH 750 96 CHEWABLE TABLETS GOES TO WORK IN SECONDS! PAREVE ©2014 GSK Front Label: 103710XA Back Label: 103711XA Tums Extra Strength Cherry 96 count front label
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.
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.
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 Do not use if printed inner safety seal under cap is broken or missing. Gluten-Free
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
When using this product • do not take more than 9 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 (Assorted Fruit) • each tablet contains: elemental calcium 305 mg, magnesium 5 mg, sodium 2mg • store below 30°C (86°F) • contains FD&C Yellow No. 5 (tartrazine) as a color additive
Other information (Assorted Berries) • each tablet contains: elemental calcium 305 mg, magnesium 5 mg, sodium 2mg • store below 30°C (86°F)
Other information (Assorted Tropical Fruit, Wintergreen, Cherry) • each tablet contains: elemental calcium 300 mg, sodium 2 mg • store below 30°C (86°F)
Other information (Orange Cream) • each tablet contains: elemental calcium 300 mg • store below 30°C (86°F) Phenylketonurics: Contains phenylalanine, less than 1mg per tablet.
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 (Assorted Fruit, Assorted Berries, Assorted Tropical Fruit, Wintergreen, Cherry) 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.
Warnings (Sugar Free Orange Cream) 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 9 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