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| Product NDC Code | 0135-0228 | ||||||||||
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| Drug Name | Tums ultra |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||||
| Dosage Form | TABLET, CHEWABLE | ||||||||||
| RxCUI drug identifier | 308892, 1044524 |
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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 1000 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 2-3 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, FD&C blue #1 lake, 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 (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 (Assorted Berry) adipic acid, corn starch, FD&C blue #1 lake, FD&C red #40 lake, flavors, mineral oil, sodium polyphosphate, sucrose, talc
Inactive ingredient (Peppermint) corn starch, flavor, mineral oil, sodium polyphosphate, sucrose, talc
Inactive ingredients (Peppermint Tri-Color) corn starch, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #5 (tartrazine) 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 ULTRA calcium carbonate CALCIUM CARBONATE CARBONATE ION CALCIUM CATION SUCROSE STARCH, CORN TALC MINERAL OIL ADIPIC ACID SODIUM POLYMETAPHOSPHATE FD&C RED NO. 40 FD&C YELLOW NO. 6 FD&C YELLOW NO. 5 FD&C BLUE NO. 1 ALUMINUM OXIDE orange, yellow, green TUMS assorted fruit, orange, lemon, lime TUMS ULTRA calcium carbonate CALCIUM CARBONATE CARBONATE ION CALCIUM CATION SUCROSE STARCH, CORN TALC MINERAL OIL SODIUM POLYMETAPHOSPHATE FD&C RED NO. 40 FD&C YELLOW NO. 6 FD&C YELLOW NO. 5 ALUMINUM OXIDE red-orange, cream to off-white, light yellow TUMS assorted tropical fruit, mandarin orange, orange-pineapple, strawberry-banana TUMS ULTRA calcium carbonate CALCIUM CARBONATE CARBONATE ION CALCIUM CATION SUCROSE STARCH, CORN TALC MINERAL OIL ADIPIC ACID SODIUM POLYMETAPHOSPHATE FD&C RED NO. 40 FD&C BLUE NO. 1 ALUMINUM OXIDE mauve, bluish TUMS assorted berry, strawberry, raspberry, mixed berry TUMS ULTRA calcium carbonate CALCIUM CARBONATE CARBONATE ION CALCIUM CATION SUCROSE STARCH, CORN TALC MINERAL OIL SODIUM POLYMETAPHOSPHATE TUMS TUMS ULTRA calcium carbonate CALCIUM CARBONATE CARBONATE ION CALCIUM CATION SUCROSE STARCH, CORN TALC MINERAL OIL SODIUM POLYMETAPHOSPHATE FD&C RED NO. 40 ALUMINUM OXIDE FD&C YELLOW NO. 5 FD&C BLUE NO. 1 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 NDC 0135-0118-83 TUMS ® CALCIUM CARBONATE ANTACID ASSORTED FRUIT ULTRA STRENGTH 1000 72 CHEWABLE TABLETS GOES TO WORK IN SECONDS! ©2014 GSK PAREVE 103662XA (Front Label) 103593XA (Back Label) Tums Ultra Assorted Fruit 72 count front label
Principal Display Panel NDC 0135-0180-02 TUMS ® CALCIUM CARBONATE ANTACID TROPICAL FRUIT ULTRA STRENGTH 1000 72 CHEWABLE TABLETS GOES TO WORK IN SECONDS! ©2014 GSK PAREVE 103634XA (Front Label) 103591XA (Back Label) Tums Ultra Tropical Fruit 72 count front label
Principal Display Panel NDC 0135-0181-02 TUMS ® CALCIUM CARBONATE ANTACID ASSORTED BERRIES ULTRA STRENGTH 1000 72 CHEWABLE TABLETS GOES TO WORK IN SECONDS! ©2014 GSK PAREVE 103665XA (Front Label) 103588XA (Back Label) Tums Ultra Assorted Berries 72 count front label
Principal Display Panel NDC 0135-0228-06 TUMS ® CALCIUM CARBONATE ANTACID PEPPERMINT ULTRA STRENGTH 1000 72 CHEWABLE TABLETS GOES TO WORK IN SECONDS! ©2014 GSK 103664XA (Front Label) 103592XA (Back Label) Tums Ultra Peppermint 72 count front label
Principal Display Panel NDC 0135-0540-01 TUMS ® ANTACID CALICUM CARBONATE PEPPERMINT ULTRA STRENGTH 1000 86 CHEWABLE TABLETS 20% MORE FREE PAREVE ©2014 GSK 104475XA (Front Label) 104476XA (Back Label) Tums Ultra tricolor Peppermint 86 ct 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 400mg, sodium 2mg • store below 30 o C (86 o 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? 1-800-897-7535weekdays Safety sealed- Do not use if printed inner seal beneath cap is missing or broken. www.tums.com GlaxoSmithKline Moon Twp, PA 15108 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 7 tablets in 24 hours • if pregnant do not take more than 5 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 7 tablets in 24 hours • if pregnant do not take more than 5 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