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| Product NDC Code | 36800-478 | ||||
|---|---|---|---|---|---|
| Drug Name | Topcare antacid calcium |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, CHEWABLE | ||||
| RxCUI drug identifier | 308907 | ||||
| Application Number | M001 | ||||
| Labeler Name | Topco Associates LLC. | ||||
| 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 500mg
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 adipic acid, D & C red # 27 lake, D&C yellow # 10 lake, dextrose, FD&C blue #1 lake, FD&C yellow #6 lake, flavors, magnesium stearate, maltodextrin, starch, sucralose. Questions? 1-888-423-0139 Safety sealed: Do not use if printed seal under cap is torn or missing
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.Topcare Antacid Calcium Calcium Carbonate CALCIUM CARBONATE CARBONATE ION CALCIUM CATION 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 L478 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 # 36800-478-48 + TopCare ® health TM COMPARE TO REGULAR STRENGTH TUMS® ACTIVE INGREDIENT* Regular Strength Antacid Tablets Calcium Carbonate 500 mg FAST RELIEF OF: • Upset Stomach • Heartburn • Acid indigestion ASSORTED FRUIT FLAVORS 150 CHEWABLE TABLETS GLUTEN- FREE QUALITY GUARANTEED For questions or comments, please call 1-888-423-0139. Distributed by: TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 6007 © TOPCO RARA0918 QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrand.com Visit here for more information: http://topbrnds.com/48ZS0K *This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered trademark, Regular Strength Tums ® . TopCare Regular Strength Antacid Calcium Carbonate Assorted Fruit
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 tablet contains: elemental calcium 200mg • Store at room temperature. Keep the container tightly closed.
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? 1-888-423-0139 Safety sealed: Do not use if printed seal under cap is torn or missing
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 15 tablets in 24 hours • if pregnant do not take more than 10 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