Save up to 80% by drug discount in your pharmacy with "Pharmacy Near Me - National Drug Discount Card"
You can scan QR Code(just open camera on your phone/scan by application) from the image on prescription drug discount card to save it to your mobile phone. Or just click on image if you're on mobile phone.
| Product NDC Code | 71610-649 | ||||
|---|---|---|---|---|---|
| Drug Name | Simethicone |
||||
| Type | Generic | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
|
||||
| Route | ORAL | ||||
| Dosage Form | TABLET, CHEWABLE | ||||
| RxCUI drug identifier | 314216 | ||||
| Application Number | part332 | ||||
| Labeler Name | Aphena Pharma Solutions - Tennessee, LLC | ||||
| Packages |
|
||||
| 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 or crush tablet completely before swallowing adults and children 12 years and over: take 1-2 tablets as needed after meals and at bedtime. Do not exceed 6 tablets in 24 hours except under the advice and supervision of a doctor. children under 12 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients cellulose, corn starch, crospovidone, dextrates hydrated, flavor, magnesium stearate, silica, sucralose, calcium phosphate.
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 pressure, bloating, and fullness 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.SIMETHICONE Simethicone CELLULOSE, MICROCRYSTALLINE DEXTRATES SILICON DIOXIDE TRICALCIUM PHOSPHATE DIMETHICONE DIMETHICONE STARCH, CORN CROSPOVIDONE MAGNESIUM STEARATE SUCRALOSE 44;137
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 71610-649 - 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 71610-649-04 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 | 71610-649-04 |
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? 1-800-540-3765
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 "44 & 137" on one side and are supplied as: NDC 57896-791-01 in bottle of 100 chewable tablets NDC 57896-791-08 in bottle of 80 chewable tablets Distributed by: GERI-CARE Pharmaceuticals Corp. 1650 63rd Street, Brooklyn, NY 11204
Storage and handling
Information about safe storage and handling of the drug product.Other information each tablet contains: calcium 65 mg Tamper Evident: Do not use if imprinted seal under cap is missing or broken store at room temperature, 15°C - 30°C (59˚F - 86˚F) protect from moisture
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 out of 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