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Simethicone - Medication Information

Product NDC Code 67544-767
Drug Name

Simethicone

Type Generic
Pharm Class Skin Barrier Activity [PE]
Active Ingredients
Dimethicone 80 mg/1
Route ORAL
Dosage Form TABLET, CHEWABLE
RxCUI drug identifier 314216
Application Number part332
Labeler Name Aphena Pharma Solutions - Tennessee, LLC
Packages
Package NDC Code Description
67544-767-04 4 tablet, chewable in 1 bottle (67544-767-04)
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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 80 mg
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