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Product NDC Code | 0135-0633 | ||||
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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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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 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 (Mixed Berry) Acacia gum, alcohol, ammonium hydroxide, beeswax, carmine, carnauba wax, citric acid, coconut oil, corn starch, corn syrup, dextrin, ethyl acetate, ethyl alcohol, FD&C blue #1 alum lake, FD&C blue #2 alum lake, FD&C red #40 alum lake, FD&C yellow #6 alum lake, flavors, gum arabic, isopropyl alcohol, maltodextrin, methylparaben, n-butyl alcohol, phosphoric acid, propylparaben, propylene glycol, purified water, shellac, sorbic acid, sorbitol, soybean oil, soy lecithin, sucrose, TBHQ, titanium dioxide, vegetable oil
Inactive Ingredients (Berries & Cream) 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, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 aluminum lake (tartrazine), FD&C yellow no. 6 aluminum lake, flavors, gum arabic, isopropyl alcohol, lecithin, maltodextrin, medium chain triglycerides, methylparaben, modified starch, n-butyl alcohol, phosphoric acid, propylene glycol, propylparaben, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soybean oil, sucrose, tert-butylhydroquinone, titanium dioxide, vegetable oil
Inactive Ingredients (Lemonade) alcohol, ammonium hydroxide, beeswax, carnauba wax, citric acid, coconut oil, corn starch, corn syrup, dextrin, DL-alpha tocopherol, ethyl acetate, FD&C blue no.1 aluminum lake, FD&C blue no.2 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, gum arabic, isopropyl alcohol, lecithin, maltodextrin, medium chain triglycerides, methylparaben, modified starch, n-butyl alcohol, phosphoric acid, propylene glycol, propylparaben, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soybean oil, sucrose, tert-butylhydroquinone, titanium dioxide, vegetable oil
Inactive Ingredients (Lemon & Blueberry) 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. 5 aluminum lake (tartrazine), FD&C yellow no. 6 aluminum lake, flavors, gum arabic, isopropyl alcohol, lecithin, maltodextrin, medium chain triglycerides, methylparaben, modified starch, n-butyl alcohol, phosphoric acid, propylene glycol, propylparaben, purified water, shellac, sorbic acid, sorbitol, soybean oil, sucrose, tert-butylhydroquinone, 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 calcium carbonate ACACIA ALCOHOL AMMONIA YELLOW WAX CARMINIC ACID CARNAUBA WAX CITRIC ACID MONOHYDRATE COCONUT OIL STARCH, CORN CORN SYRUP ICODEXTRIN ETHYL ACETATE FD&C BLUE NO. 1 ALUMINUM OXIDE FD&C BLUE NO. 2 FD&C RED NO. 40 FD&C YELLOW NO. 6 ISOPROPYL ALCOHOL MALTODEXTRIN METHYLPARABEN BUTYL ALCOHOL PHOSPHORIC ACID PROPYLPARABEN PROPYLENE GLYCOL WATER SHELLAC SORBIC ACID SORBITOL SOYBEAN OIL LECITHIN, SOYBEAN SUCROSE TERT-BUTYLHYDROQUINONE TITANIUM DIOXIDE CORN OIL CALCIUM CARBONATE CALCIUM CATION CARBONATE ION T Mixed berry: Raspberry and Blueberry Tums Chewy Bites calcium carbonate ALCOHOL AMMONIA YELLOW WAX CARNAUBA WAX CITRIC ACID MONOHYDRATE COCONUT OIL STARCH, CORN CORN SYRUP ICODEXTRIN ETHYL ACETATE FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 ACACIA ISOPROPYL ALCOHOL LECITHIN, SOYBEAN MALTODEXTRIN MEDIUM-CHAIN TRIGLYCERIDES METHYLPARABEN MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) BUTYL ALCOHOL PHOSPHORIC ACID PROPYLENE GLYCOL WATER SHELLAC SODIUM BENZOATE SORBIC ACID SORBITOL SOYBEAN OIL SUCROSE TERT-BUTYLHYDROQUINONE TITANIUM DIOXIDE CORN OIL CALCIUM CARBONATE CALCIUM CATION CARBONATE ION Blue/White/Red Blue/White/Red Blue/White/Red T Tums Chewy Bites calcium carbonate TERT-BUTYLHYDROQUINONE TITANIUM DIOXIDE ALCOHOL AMMONIA YELLOW WAX CARNAUBA WAX CITRIC ACID MONOHYDRATE COCONUT OIL STARCH, CORN CORN SYRUP ICODEXTRIN .ALPHA.-TOCOPHEROL, DL- ETHYL ACETATE FD&C BLUE NO. 1 FD&C BLUE NO. 2 FD&C RED NO. 40 FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 ACACIA ISOPROPYL ALCOHOL LECITHIN, SOYBEAN MALTODEXTRIN MEDIUM-CHAIN TRIGLYCERIDES METHYLPARABEN MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) BUTYL ALCOHOL PHOSPHORIC ACID PROPYLENE GLYCOL WATER SHELLAC SODIUM BENZOATE SORBIC ACID SORBITOL SOYBEAN OIL SUCROSE CORN OIL CALCIUM CARBONATE CALCIUM CATION CARBONATE ION Pink/Yellow Pink/Yellow T Tums Chewy Bites calcium carbonate ALCOHOL AMMONIA YELLOW WAX CARNAUBA WAX CITRIC ACID MONOHYDRATE COCONUT OIL STARCH, CORN CORN SYRUP ICODEXTRIN ETHYL ACETATE FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 ACACIA ISOPROPYL ALCOHOL LECITHIN, SOYBEAN MALTODEXTRIN MEDIUM-CHAIN TRIGLYCERIDES METHYLPARABEN MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) BUTYL ALCOHOL PHOSPHORIC ACID PROPYLENE GLYCOL WATER SHELLAC SORBIC ACID SORBITOL SOYBEAN OIL SUCROSE TERT-BUTYLHYDROQUINONE TITANIUM DIOXIDE CORN OIL CALCIUM CARBONATE CALCIUM CATION CARBONATE ION blue Yellow T Lemon and Blueberry
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 0135-0618-01 TUMS ® CALCIUM CARBONATE ANTACID Chewy Bites Mixed Berry NEW GOES TO WORK IN SECONDS! EXTRA STRENGTH 750 2 CHEWABLE TABLETS Safety sealed : Do not use if packet is damaged or open. Distributed by: GSK Consumer Healthcare Warren, NJ 07059 Trademarks are owned by or licensed to the GSK group of companies. ©2016 GSK or its licensor 105902XA C:\Users\sh821028\Pictures\105902XA_TUMS_CB_Mixed Berry_Tabs_2ct_Pch.jpg
Principal Display Panel NDC 0135-0631-01 TUMS CALCIUM CARBONATE ANTACID Chewy Bites Berries & Cream Made in the USA GOES TO WORK IN SECONDS! EXTRA STRENGTH 750 32 CHEWABLE TABLETS Do not use if printed inner safety seal under cap is broken or missing. Distributed by: GSKConsumer Healthcare Warren, NJ 07059 Trademarks are owned by or licensed to the GSK group of companies. ©2018 GSK or its licensor. 1000037 1000037_TUMS Chewy Bites Berries and Cream_32 Chewable Tablets.JPG
Principal Display Panel NDC 0135-0630-01 TUMS CALCIUM CARBONATE ANTACID Chewy Bites lemonade Limited Edition GOES TO WORK IN SECONDS! EXTRA STRENGTH 750 60 CHEWABLE TABLETS Do not use if printed inner safety seal under cap is broken or missing. Distributed by: GSKConsumer Healthcare Warren, NJ 07059 Trademarks are owned by or licensed to the GSK group of companies. ©2018 GSK or its licensor. 1000034 1000034_TUMS Chewy Bites Lemonade_60 ct.JPG
Principal Display Panel NDC 0135-0633-01 TUMS CALCIUM CARBONATE ANTACID Chewy Bites Lemon & Blueberry Limited Edition GOES TO WORK IN SECONDS! EXTRA STRENGTH 750 32 CHEWABLE TABLETS Do not use if printed inner safety seal under cap is broken or missing. Distributed by: GSKConsumer Healthcare Warren, NJ 07059 Trademarks are owned by or licensed to the GSK group of companies. ©2019 GSK or its licensor. 1000290 1000290_TUMS Chewy Bites Lemon & Blueberry_32 ct.JPG
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)
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? 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