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| Product NDC Code | 68016-668 | ||||
|---|---|---|---|---|---|
| Drug Name | Premier value chewable antacid extra strength tropical fruit |
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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 | 308907 | ||||
| Application Number | M001 | ||||
| Labeler Name | Chain Drug Consortium | ||||
| 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 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 swallow tablets whole. • 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 adipic acid, D&C Yellow No 10, dextrose, FD&C Red No 40, FD&C Yellow No. 6, flavors, magnesium stearate, maltodextrin, starch, sucralose.
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 • sour stomach • acid indigestion • 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.Premier Value Chewable Antacid Extra Strength Tropical Fruit Antacid Tablets CALCIUM CARBONATE CALCIUM CATION ADIPIC ACID D&C YELLOW NO. 10 DEXTROSE, UNSPECIFIED FORM FD&C RED NO. 40 FD&C YELLOW NO. 6 MAGNESIUM STEARATE MALTODEXTRIN STARCH, CORN SUCRALOSE RP102
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.Package/Label Principal Display Panel Compare to the Active Ingredient in Tums* Premier Value Extra Strength Antacid Tablets Calcium Carbonate USP 750 mg Fast Relief of Heartburn, Acid Indigestion & Upset Stomach TROPICAL FRUIT Naturally and Artificially Flavored 96 Chewable Tablets Distributed by : Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, PA 19087 This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark, Extra Strength Tums® Safety sealed: Do not use if printed seal under cap is torn or missing Premier Value Extra Strength Tropical Fruit Antacid 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 tablets contains : elemental calcium 300mg • Keep the container tightly closed • Store at room temperature.
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
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 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.
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