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| Product NDC Code | 68196-103 | ||||
|---|---|---|---|---|---|
| Drug Name | Ultra strength assorted berries |
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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 | 308892 | ||||
| Application Number | M001 | ||||
| Labeler Name | SAM'S WEST INC | ||||
| 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 1000mg
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 adipic acid, blue 1 lake, dextrose, flavors, magnesium stearate, red 40 lake, 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 • 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.Ultra Strength Assorted Berries Calcium Carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION ADIPIC ACID FD&C BLUE NO. 1 DEXTROSE, UNSPECIFIED FORM MAGNESIUM STEARATE MALTODEXTRIN FD&C RED NO. 40 STARCH, CORN SUCRALOSE RP103 assorted berry
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 Member’s Mark ™ COMPARE TO TUMS ® Ultra Strength active ingredient* ULTRA STRENGTH 1000 ANTACID TABLETS Calcium Carbonate Assorted Berry Flavors Naturally and Artificially Flavored GLUTEN FREE K PAREVE DISTRIBUTED BY SAM’S WEST, INC. BENTONVILLE, AR 72716 For comments or suggestions, call us toll-free at 1.888-301-0332 from 8 a.m. to 5 p.m. CST Monday-Friday *This product is not manufactured or distributed by GlaxoSmithKline, the distributor of Tums®. Package Label 265 Chewable Tablets SAM'S West Ultra Strength 1000 Antacid 265 Tablets
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.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Safety Sealed: Do not use if printed seal under cap is torn or missing
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 or comments? 1-888-301-0332 Safety Sealed: Do not use if printed seal under cap is torn or missing
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
Storage and handling
Information about safe storage and handling of the drug product.Other information • each tablet contains: elemental calcium 400mg • Store at room temperature
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
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