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| Product NDC Code | 0135-0246 | ||||||||||||
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| Drug Name | Tums smoothies |
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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 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 • 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, dextrose, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #5 (tartrazine) lake, FD&C yellow #6 lake, flavors, guar gum, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose Contains: soy
Inactive ingredients (Berry Fusion) adipic acid, corn starch, dextrose, FD&C blue #1 lake, FD&C red #40 lake, flavors, guar gum, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose Contains: soy
Inactive ingredient (Assorted Tropical Fruit) adipic acid, corn starch, dextrose, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #6 lake, flavors, guar gum, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose Contains: soy
Inactive ingredients (Peppermint) corn starch, dextrose, flavors, guar gum, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose
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 Smoothies calcium carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION ADIPIC ACID STARCH, CORN DEXTROSE, UNSPECIFIED FORM FD&C BLUE NO. 1 ALUMINUM OXIDE FD&C RED NO. 40 FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 GUAR GUM MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE SORBITOL SUCROSE orange, dark pink, yellow TUMS;SD Assorted flavor, orange, strawberry, lemon TUMS Smoothies calcium carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION ADIPIC ACID STARCH, CORN DEXTROSE, UNSPECIFIED FORM FD&C BLUE NO. 1 ALUMINUM OXIDE FD&C RED NO. 40 GUAR GUM MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE SORBITOL SUCROSE mauve, peach, dark pink TUMS;SD Berry Fusion, citrus berry, orange passion, strawberry TUMS Smoothies calcium carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION ADIPIC ACID STARCH, CORN DEXTROSE, UNSPECIFIED FORM FD&C BLUE NO. 1 ALUMINUM OXIDE FD&C RED NO. 40 FD&C YELLOW NO. 6 GUAR GUM MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE SORBITOL SUCROSE peach, mauve TUMS;SD Assorted Tropical Fruit, orange passion, citrus berry, mixed fruit TUMS Smoothies calcium carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION STARCH, CORN DEXTROSE, UNSPECIFIED FORM GUAR GUM MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE SORBITOL SUCROSE TUMS;SD
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 0135-0246-02 TUMS ® CALCIUM CARBONATE ANTACID Smoothies TM Assorted Fruit SMOOTH DISSOLVE EXTRA STRENGTH 750 GOES TO WORK IN SECONDS! 60 CHEWABLE TABLETS PAREVE ©2014 GSK Safety sealed – Do not use if printed inner seal beneath cap is missing or broken. GlaxoSmithKline Moon Twp, PA 15108 Gluten-Free www.tums.com Front Panel 103644XA Back Panel 103553XA Tums Smoothies Assorted Fruit 60 count front label
Principal Display Panel NDC 0135-0456-03 TUMS ® CALCIUM CARBONATE ANTACID Smoothies TM Berry Fusion SMOOTH DISSOLVE EXTRA STRENGTH 750 GOES TO WORK IN SECONDS! 60 CHEWABLE TABLETS PAREVE Safety sealed – Do not use if printed inner seal beneath cap is missing or broken. GSK CH Warren, NJ 07059 Gluten-Free ©2014 GSK Front Panel 103680XA Back Panel 103725XA Tums Smoothies Berry Fusion 60 count front label
Principal Display Panel NDC 0135-0245-02 TUMS ® CALCIUM CARBONATE ANTACID Smoothies TM Tropical Fruit SMOOTH DISSOLVE EXTRA STRENGTH 750 GOES TO WORK IN SECONDS! 60 CHEWABLE TABLETS PAREVE ©2014 GSK Safety sealed – Do not use if printed inner seal beneath cap is missing or broken. GlaxoSmithKline Moon Twp, PA 15108 Gluten-Free www.tums.com Front Panel 103818XA Back Panel 103816XA Tums Smoothies Tropical Fruit 60 count front label
Principal Display Panel NDC 0135-0243-02 TUMS ® CALCIUM CARBONATE ANTACID Smoothies TM Peppermint SMOOTH DISSOLVE EXTRA STRENGTH 750 GOES TO WORK IN SECONDS! 60 CHEWABLE TABLETS PAREVE Safety sealed – Do not use if printed inner seal beneath cap is missing or broken. Trademarks are owned by or licensed to the GSK group of companies. GSK Consumer Healthcare Warren, NJ 07059 Gluten-Free ©2015 GSK or its licensor. Front Panel 103728XB Back Panel 103727XB Tums Smoothies Peppermint 60 count front 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 300mg • store below 25 o C (77 o F). Keep the container tightly closed.
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? 1-800-897-7535 weekdays
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
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 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.
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