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| Product NDC Code | 68163-111 | ||||
|---|---|---|---|---|---|
| Drug Name | Gas relief mint flavor |
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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 | part332 | ||||
| Labeler Name | Raritan Pharmaceuticals Inc | ||||
| 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 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 • thoroughly chew 1 to 2 tablets as needed after meals and at bedtime • do not exceed 4 tablets in 24 hours 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, peppermint 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: • bloating • pressure • symptoms referred to as gas
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.Gas Relief Mint Flavor Simethicone DIMETHICONE DIMETHICONE DEXTROSE, UNSPECIFIED FORM PEPPERMINT MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE TRICALCIUM PHOSPHATE 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.Principal Display Panel NDC 68163-111-36 DRx CHOICE Gas Relief Anti Gas/Simethicone 80 mg For fast relief of Bloating, Pressure & Gas Distress Mint Flavor Naturally and Artificially Flavored 36 CHEWABLE TABLETS Manufactured by: Raritan Pharmaceuticals 8 Joanna Court, East Brunswick, NJ 08816 Simethicone 36 Chewable Tablets DRx Choice Simethicone 36 Chewable 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. In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.
Storage and handling
Information about safe storage and handling of the drug product.Other information • store at room temperature 20-25ºC (68-77ºF) • each tablets contains: calcium 60mg
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. In case of overdose, 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