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Simethicone 80mg - Medication Information

Product NDC Code 77333-812
Drug Name

Simethicone 80mg

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 Gendose Pharmaceuticals, LLC
Packages
Package NDC Code Description
77333-812-10 100 blister pack in 1 box (77333-812-10) / 1 tablet, chewable in 1 blister pack (77333-812-25)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENT (IN EACH TABLET) SIMETHICONE 80MG

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 ADULTS CHEW 1 OR 2 TABLETS COMPLETELY AS NEEDED AFTER MEALS AND AT BEDTIME. DO NOT SWALLOW TABLETS WHOLE. DO NOT EXCEED 6 TABLETS IN 24 HOUR PERIOD EXCEPT UNDER THE ADVICE AND SUPERVISION OF A PHYSICIAN.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENTS DEXTROSE, FLAVOR, MAGNESIUM STEARATE, MALTODEXTRIN, MICROCRYSTALLINE CELLULOSE, SILICA, TRIBASIC 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 GAS DISTRESS, BLOATING, AND DISCOMFORT

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 80MG SIMETHICONE MAGNESIUM STEARATE DEXTROSE MALTODEXTRIN TRIBASIC CALCIUM PHOSPHATE MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE DIMETHICONE DIMETHICONE RP111

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.
01b LBL_Simethicone_80mg_100 tablets

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.

Storage and handling

Information about safe storage and handling of the drug product.
OTHER INFORMATION EACH TABLET CONTAINS: CALCIUM 60MG STORE AT ROOM TEMPERATURE

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 GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY AT 1-800-222-1222.

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