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| Product NDC Code | 68163-011 | ||||
|---|---|---|---|---|---|
| Drug Name | Fast acting heartburn relief peppermint flavor |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, CHEWABLE | ||||
| RxCUI drug identifier | 308907 | ||||
| Application Number | part331 | ||||
| Labeler Name | Raritan Pharmaceuticals 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 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 older: 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 Gum acacia, magnesium stearate, microcrystalline cellulose, natural peppermint oil, polyplasdone, sucrose. Questions or comments? 1-866-467-2748 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.Fast Acting Heartburn Relief Peppermint Flavor Calcium Carbonate CALCIUM CARBONATE CARBONATE ION CALCIUM CATION ACACIA MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE PEPPERMINT OIL CROSPOVIDONE (120 .MU.M) SUCROSE RP101
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 68163-011-00 *COMPARE TO THE ACTIVE INGREDIENT IN REGULAR STRENGTH TUM® FAST ACTING HEARTBURN RELIEF FOR FAST RELIEF OF: ACID INDIGESTION, SOUR STOMACH & HEARTBURN PEPPERMINT FLAVOR GLUTEN FREE 100 CHEWABLE TABLETS KOSHER FOR PASSOVER This product does not contain any Chometz or Kitnius This product contains no animal soybean, or grain derivatives. Manufactured for: Adwe Laboratories 1274 49 Street, Brooklyn, NY 11219 *This product is not manufactured or distributed by GlaxoSmithKline LLC, the owner of the registered trademark Regular Strength Tums ® . Fast Acting Heartburn Relief Antacid 100 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 • 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 or comments? 1-866-467-2748 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