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| Product NDC Code | 0924-0287 | ||||
|---|---|---|---|---|---|
| Drug Name | First aid only 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 | 313884 | ||||
| Application Number | part331 | ||||
| Labeler Name | Acme United Corporation | ||||
| 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 (in each tablet) Calcium Carbonate 420 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 do not use more than directed Adults and children: (12 years and older) Chew 2 tablets every 2 or 3 hours as symptoms occur or as directed by a physician. Do not take more than 19 tablets in 24 hours. Children under 12 years: Do not give to children under 12 years of age.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aspartame*, croscarmellose sodium*, gum acacia*, magnesium stearate, maltodextrin, mineral oil*, mint flavor, sorbitol*, sucrose* * may contain
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 For the relief of the following symptoms associated with acid indigestion sour stomach heartburn 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.First Aid Only Antacid calcium carbonate ASPARTAME CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MALTODEXTRIN MINERAL OIL SORBITOL CALCIUM CARBONATE CALCIUM CATION CARBONATE ION white ROUND AZ;036
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.First Aid Only Antacid Label First Aid Only Antacid Label
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
Other information Phenylketonurics: contains phenylalanine 1.5 mg per tablet each tablet contains 168 mg of elemental calcium store at room temperature 59-86°F (15-30°C) in a dry place tamper-evident sealed packets do not use any opened or torn packets
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor or phamacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product do not take more than 19 tablets in 24 hours do not use the maximum dosage for more than 2 weeks except under the advise and supervision of a physician do not exceed recommended dosage
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 the reach of children. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.
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 1-800-835-2263
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 using this product and ask a doctor if symptoms last more than 2 weeks
Pregnancy or breast feeding
Pregnancy or Breast feedingIf you are pregnant or breast feeding, ask a health profdessional before use.
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 phamacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product do not take more than 19 tablets in 24 hours do not use the maximum dosage for more than 2 weeks except under the advise and supervision of a physician do not exceed recommended dosage Stop using this product and ask a doctor if symptoms last more than 2 weeks Keep out of the reach of children. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. If you are pregnant or breast feeding, ask a health profdessional before use.
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