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| Product NDC Code | 63187-516 | ||||
|---|---|---|---|---|---|
| Drug Name | Pluspharma |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, CHEWABLE | ||||
| RxCUI drug identifier | 314216 | ||||
| Application Number | part347 | ||||
| Labeler Name | Proficient Rx LP | ||||
| 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) Simethicone 80 mg, USP
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: Chew 1 or 2 tablets as needed after meals and at bedtime. • Do not exceed 6 tablets per day except under the advice and supervision of a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Fructose, Maltodextrin, Natural and Artificial Spearmint Flavor, Silicon Dioxide, Sorbitol, Starch and Stearic Acid.
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 bloating and pressure commonly referred to as gas.
Purpose
Information about the drug product’s indications for use.Purpose Anti-Gas
Spl product data elements
Usually a list of ingredients in a drug product.PlusPHARMA Simethicone DIMETHICONE DIMETHICONE FRUCTOSE MALTODEXTRIN SILICON DIOXIDE SORBITOL STARCH, CORN STEARIC ACID Round Flat Faced Beveled Edge GPI;LB Natural and Artificial
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.Principal Display Panel PlusPHARMA SIMETHICONE 80 mg ANTI GAS Acts Fast to Relieve: • Bloating • Discomfort • Pressure Compare to the Active Ingredient in Gas-X® Chewables. This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Gas-X® Chewables. 100 CHEWABLE TABLETS 80mg Each Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 63187-516-00
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 • Store at room temperature. • Avoid high humidity. • Do not use if imprinted safety seal under cap is broken or missing.
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? If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding , ask a health professional 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 If pregnant or breast-feeding , ask a health professional before use. 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