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Simethicone - Medication Information

Product NDC Code 68071-2746
Drug Name

Simethicone

Type Generic
Pharm Class Skin Barrier Activity [PE]
Active Ingredients
Dimethicone 80 mg/1
Route ORAL
Dosage Form TABLET, CHEWABLE
RxCUI drug identifier 314216
Application Number part332
Labeler Name NuCare Pharmaceuticals,Inc.
Packages
Package NDC Code Description
68071-2746-3 30 tablet, chewable in 1 bottle (68071-2746-3)
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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 STARCH, CORN CROSPOVIDONE MAGNESIUM STEARATE SUCRALOSE DIMETHICONE DIMETHICONE 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.
package Label pdp

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

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