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Product NDC Code | 63868-048 | ||||
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Drug Name | Quality choice ultra strength assorted fruit |
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Type | Brand | ||||
Active Ingredients |
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Route | ORAL | ||||
Dosage Form | TABLET, CHEWABLE | ||||
RxCUI drug identifier | 308892 | ||||
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 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 • Chew 2-3 tablets as symptoms occur, or as directed by a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients adipic acid, FD&C Blue No. 1, dextrose, flavors, magnesium stearate, maltodextrin, D&C Red No. 27, starch, sucralose, FD&C Yellow No. 6, D&C Yellow No. 10.
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.Quality Choice Ultra Strength Assorted Fruit Calcium Carbonate CALCIUM CARBONATE CARBONATE ION CALCIUM CATION ADIPIC ACID FD&C BLUE NO. 1 DEXTROSE, UNSPECIFIED FORM MAGNESIUM STEARATE MALTODEXTRIN D&C RED NO. 27 STARCH, CORN SUCRALOSE FD&C YELLOW NO. 6 D&C YELLOW NO. 10 RP103 assorted fruit
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 NDC 63868-048-72 Compare to Tums ® Ultra Strength active ingredient* Ultra Strength Antacid Tablets Antacid Calcium Supplement Calcium Carbonate 1000 mg Relieves: Upset Stomach Heartburn Acid Indigestion Assorted Fruit 72 Chewable Tablets K PAREVE GLUTEN- FREE QC SATISFACTION GURANTEED ©Distributed by C.D.M.A., Inc., 43157 W. Nine Mile www.qualitychoice.com Questions: 248-449-9300 *This product is not manufactured or distributed by GlaxoSmithKline LLC, the distributor of Tums®. Quality Choice Ultra Strength Antacid 72 Chewable 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 • Store below 30°C (86°F) • Keep the container tightly closed • For calcium and magnesium content see Supplement Facts 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.
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 • do not use the maximum dosage for more than 2 weeks.
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