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Simethicone - Medication Information

Product NDC Code 68210-0314
Drug Name

Simethicone

Type Generic
Pharm Class Skin Barrier Activity [PE]
Active Ingredients
Dimethicone 180 mg/1
Route ORAL
Dosage Form CAPSULE, GELATIN COATED
RxCUI drug identifier 252294
Application Number M002
Labeler Name Spirit Pharmaceuticals LLC
Packages
Package NDC Code Description
68210-0314-5 1 bottle in 1 carton (68210-0314-5) / 50 capsule, gelatin coated in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each softgel) Simethicone 180 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.
Use for the relief of ■ pressure and bloating commonly referred to as gas

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients FD&C yellow #6, gelatin, glycerin, peppermint oil, povidone, purified water, sorbitol solution, titanium dioxide

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.
Directions ■ adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime ■ do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician

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.
Simethicone Simethicone FD&C YELLOW NO. 6 GELATIN GLYCERIN PEPPERMINT OIL WATER SORBITOL SOLUTION TITANIUM DIOXIDE DIMETHICONE DIMETHICONE OPAQUE 161

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 ULTRA STRANGTH GAS RELIEF Simethicone 180 mg / anti-gas Fast relief of: • bloating • pressure • fullness • gas 50 SOFTGELS image description

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

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.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information ■ store at controlled room temperature 20-25°C (68-77°F) ■ protect from heat and moisture

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? 1-888-333-9792

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