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Product NDC Code | 11822-1512 | ||||
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Drug Name | Kids antacid |
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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 | 317865 | ||||
Application Number | M001 | ||||
Labeler Name | RITE AID CORPORATION | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Calcium Carbonate 400 mg
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 ▪ find the right dose on chart below based on weight (preferred), otherwise use age ▪ repeat dose as needed ▪ do not take more than 3 tablets (ages 2-5) or 6 tablets (ages 6-11) in a 24-hour period, or use the maximum dosage for more than two weeks, except under the advice and supervision of a doctor. Dosing Chart Weight (lbs.) Age Dose under 24 under 2 yrs ask a doctor 24-47 2-5 yrs 1 tablet 48-95 6-11 yrs 2 tablets
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients D&C Red No. 40 Lake, dextrose, magnesium stearate, maltodextrin, flavor, sorbitol, 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 ▪ sour stomach ▪ acid indigestion ▪ upset stomach due to these symptoms or overindulgence in food and drink
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.Kids Antacid Calcium Carbonate CALCIUM CARBONATE CALCIUM CATION CARBONATE ION FD&C RED NO. 40 DEXTROSE, UNSPECIFIED FORM MAGNESIUM STEARATE MALTODEXTRIN SORBITOL STARCH, CORN SUCRALOSE RP151
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 - 24 Tablet Carton Compare to the active ingredient in Pepto Kids Antacid Chewables* NDC 11822-1512-4 Relieves: • Acid Indigestion • Heartburn • Sour Stomach • Upset Stomach 24 Chewable Tablets For ages 2 to 11 years Bubble Gum Flavor Naturally and Artificially Flavor Kids Antacid Tablets 24 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.Drug Facts
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 the child is ▪ 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 this and all drugs out of the 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? 1-866-467-2748
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if symptoms last more than two weeks.
Storage and handling
Information about safe storage and handling of the drug product.Other information • each tablet contains: calcium 160 mg • sodium free • store at room temperature, keep tightly closed and dry.
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 the child is ▪ presently taking a prescription drug. Antacids may interact with certain prescription drugs. Stop use and ask a doctor if symptoms last more than two weeks. Keep this and all drugs out of the 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