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| Product NDC Code | 67544-767 | ||||
|---|---|---|---|---|---|
| Drug Name | Simethicone |
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| Type | Generic | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, CHEWABLE | ||||
| RxCUI drug identifier | 314216 | ||||
| Application Number | part332 | ||||
| Labeler Name | Aphena Pharma Solutions - Tennessee, LLC | ||||
| 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 chewable tablet) Simethicone 80 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 thoroughly 1 to 2 tablets as needed after meals and at bed time. do not exceed 6 tablets per day unless directed by a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients dextrose, dipac sugar, maltodextrin, peppermint flavor, sorbitol, 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 pressure discomfort of gas which can be caused by certain foods or air swallowing
Purpose
Information about the drug product’s indications for use.Purpose Antiflatulent
Spl product data elements
Usually a list of ingredients in a drug product.Simethicone Simethicone DIMETHICONE DIMETHICONE DEXTROSE SUCROSE MALTODEXTRIN PEPPERMINT SORBITOL STEARIC ACID AP;019
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 - 80mg NDC 67544-767 Simethicone (MTAB) 80mg - Rx Only Bottle Label 80mg
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 store at room temperature 15-30 °C (59-86 °F) protect from moisture
Repackaging Information Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 80 mg 4 67544-767-04 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20171222DKJ Aphena Pharma Solutions - TN
| Count | |
| 4 | 67544-767-04 |
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 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED Distributed by: Qualitest Pharmaceuticals, Inc.
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.
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