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Simethicone 80 mg - Medication Information

Product NDC Code 82804-043
Drug Name

Simethicone 80 mg

Type Brand
Pharm Class Skin Barrier Activity [PE]
Active Ingredients
Dimethicone 80 mg/1
Route ORAL
Dosage Form TABLET, CHEWABLE
RxCUI drug identifier 314216
Application Number M002
Labeler Name Proficient Rx LP
Packages
Package NDC Code Description
82804-043-30 30 tablet, chewable in 1 bottle, plastic (82804-043-30)
82804-043-60 60 tablet, chewable in 1 bottle, plastic (82804-043-60)
82804-043-90 90 tablet, chewable in 1 bottle, plastic (82804-043-90)
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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 • thoroughly chew 1-2 tablets as needed after meals and at bedtime • do not take more then 6 tablets per day

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients compressible sugar, dextrose, maltodextrin, micdocrystalline cellulose, peppermint flavor, Silicon dioxide, 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.
Use relieves bloating, pressure and fullness commonly referred to as gas

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 80 mg Simethicone MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE MALTODEXTRIN SORBITOL STEARIC ACID DIMETHICONE DIMETHICONE SUCROSE DEXTROSE, UNSPECIFIED FORM PEPPERMINT Off White 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.
NDC 82804-043-30 Simethicone 80 mg ANTIFLATULENT 30 CHEWABLE TABLETS 82804-043-30

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 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by: Reliable 1 Laboratories LLC Valley Stream, NY 11580 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 www.reliable1labs.com

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? call 516-341-0666 , 8:30 am to 4:30 pm ET, Monday - Friday

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at room temperature 15°-30°C (59°-86°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 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