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| Product NDC Code | 71610-650 | ||||
|---|---|---|---|---|---|
| Drug Name | Antiflatulent |
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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 | 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 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 2 to 4 tablets thoroughly as needed after meals and at bedtime 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 compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol.
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.USE(S) relieves: pressure bloating symptoms referred to as gas
Purpose
Information about the drug product’s indications for use.PURPOSE Antigas
Spl product data elements
Usually a list of ingredients in a drug product.Antiflatulent Simethicone DIMETHICONE DIMETHICONE SUGARCANE MALTODEXTRIN DEXTROSE, UNSPECIFIED FORM MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SORBITOL G;103
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 - 80 mg NDC 71610-650 - Simethicone 80 mg Chewable Tablet - Rx Only Bottle Label 80 mg
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.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 71610-650-04 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 20220519JK Aphena Pharma Solutions - TN
| Count | |
| 4 | 71610-650-04 |
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 In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS Call (800) 616-2471
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED Simethicone Chewable Tablets, 80 mg are white, round, tablets, debossed with "G and 103" on one side and are supplied as: NDC 0904-7206-60 in bottle of 100 chewable tablets Distributed by: Major Pharmaceuticals Livonia, MI 48152
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION do not use if inner seal is broken store at room temperature avoid high humidity and excessive heat, above 40 o C (104 o F)
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 .
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