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Product NDC Code | 17714-043 | ||||||
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Drug Name | Antacid |
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Type | Brand | ||||||
Pharm Class | Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE] |
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Active Ingredients |
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Route | ORAL | ||||||
Dosage Form | TABLET, CHEWABLE | ||||||
RxCUI drug identifier | 308907 | ||||||
Application Number | part331 | ||||||
Labeler Name | Advance Pharmaceutical Inc. | ||||||
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 500 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 chew 1-2 tablets as symptoms occurs. do not take more than 8 tablets in 24 hours do not use the maximum dosage for more than 2 weeks
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Al-lakes (D&C red #27, D&C yellow # 10, FD&C blue #1, FD&C yellow # 6), dextrose, flavors (cherry, lemon, lime, orange), magnesium stearate, maltodextrin
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 acid indigestion heartburn sour stomach
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.ANTACID Calcium Carbonate DEXTROSE MAGNESIUM STEARATE MALTODEXTRIN CHERRY CALCIUM CARBONATE CALCIUM CATION AP;043 Cherry,Lemon,Orange
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 Calcium Carbonate 500 mg Antacid tablets NDC: 17714-043-15 – 150 COUNT b43c92b6-figure-01 b43c92b6-figure-02 1
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: calcium 200 mg store at room temperature 15-30 °C (59-86 °F)
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. In case of overdose, get medical help or contact a Poison Control Center right away.
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 Call 631-981-4600, Monday-Friday, 8.30 am – 4.30 pm ET TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Manufactured by: Advance Pharmaceutical Inc. Holtsville, NY 11742
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 before use if you have kidney stones a calcium-restricted diet ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. Stop use and ask a doctor if symptoms last 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