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Simethicone - Medication Information

Product NDC Code 51013-439
Drug Name

Simethicone

Type Generic
Pharm Class Skin Barrier Activity [PE]
Active Ingredients
Dimethicone 250 mg/1
Route ORAL
Dosage Form CAPSULE, LIQUID FILLED
RxCUI drug identifier 412111
Application Number part332
Labeler Name PURACAP PHARMACEUTICAL LLC
Packages
Package NDC Code Description
51013-439-02 1 blister pack in 1 carton (51013-439-02) / 12 capsule, liquid filled in 1 blister pack
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Simethicone 250 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 ▪ swallow one or two softgels after a meal ▪ do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients D&C red # 33, FD&C blue # 1, gelatin, glycerin, purified water and white edible ink

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 or 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 DIMETHICONE DIMETHICONE D&C RED NO. 33 FD&C BLUE NO. 1 GELATIN, UNSPECIFIED GLYCERIN WATER Clear Oval PC31

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.
Package/Label Principal Display Panel – Principal Display Panel MS Gas Relief-Simeth 250mg.jpg Package/Label Principal Display Panel – Drug Facts MS Gas Relief-Simeth 250mg.jpg

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 room temperature 59°-86°F (15°-30°C)

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 toll free: 1-855-215-8180

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 Stop use and ask a doctor if condition persists 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