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Product NDC Code | 63868-702 | ||||
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Drug Name | Quality choice extra strength assorted fruit |
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Type | Brand | ||||
Active Ingredients |
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Route | ORAL | ||||
Dosage Form | TABLET, CHEWABLE | ||||
RxCUI drug identifier | 308915 | ||||
Application Number | M001 | ||||
Labeler Name | CHAIN DRUG MARKETING ASSOCIATION | ||||
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 completely 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 Red No. 27, D&C Yellow 10, dextrose, FD &C Blue No. 1, FD&C Yellow No. 6, flavors, magnesium stearate, maltodextrin, starch, 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 • 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.Quality Choice Extra Strength Assorted Fruit Calcium Carbonate CALCIUM CARBONATE CARBONATE ION ADIPIC ACID D&C RED NO. 27 D&C YELLOW NO. 10 DEXTROSE, UNSPECIFIED FORM FD&C BLUE NO. 1 FD&C YELLOW NO. 6 MAGNESIUM STEARATE MALTODEXTRIN STARCH, CORN SUCRALOSE RP102 lemon, orange, cherry, lime
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 63868-702-96 *Compare to the Active Ingredient in Extra Strength Tums ® EXTRA STRENGTH Antacid Tablets Calcium Carbonate 750 mg Relieves: • Upset Stomach • Heartburn • Acid Indigestion ASSORTED FRUIT Naturally and Artificially Flavored K PAREVE 96 Chewable Tablets GLUTEN FREE 100% QC SATISFACTION GUARANTEED Distributed by: C.D.M.A. Inc.© 43157 W 9 Mile Rd Novi, MI 48375 www.qualitychoice.com Questions: 248-449-9300 *This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered trademark, Extra Strength Tums ® Quality Choice Extra Strength Assorted Fruit Chewable 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.
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? 1-866-467-2748 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 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
Storage and handling
Information about safe storage and handling of the drug product.Other information • each tablet contains: elemental calcium 300 mg • store at room temperature. Keep the container tightly closed.
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