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| Product NDC Code | 77333-812 | ||||
|---|---|---|---|---|---|
| Drug Name | Simethicone 80mg |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, CHEWABLE | ||||
| RxCUI drug identifier | 314216 | ||||
| Application Number | M002 | ||||
| Labeler Name | Gendose Pharmaceuticals, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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