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| Product NDC Code | 68016-811 | ||||
|---|---|---|---|---|---|
| Drug Name | Premier value extra strength |
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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 | 314221 | ||||
| Application Number | M002 | ||||
| Labeler Name | PHARMACY VALUE ALLIANCE, 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 125 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 • adults : chew 1 to 2 tablets as needed after meals and at bedtime. • do not exceed 4 tablets in a 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 No. 30, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sucralose, 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 For the relief of ▪ 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.Premier Value Extra Strength Simethicone DIMETHICONE, UNSPECIFIED DIMETHICONE D&C RED NO. 30 DEXTROSE, UNSPECIFIED FORM MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE SUCRALOSE TRIBASIC CALCIUM PHOSPHATE RP110 CREME
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 Premier Value ® NDC 68016-811-18 *Compare to the active ingredient in Gas-X ® Extra Strength Extra Strength Gas Relief Antigas/Simethicone 125 mg Relieves: • Pressure • Bloating • Discomfort Cherry Creme Flavor Naturally and Artificially Flavored 18 CHEWABLE TABLETS K PAREVE *This product is not manufactured or distributed by GSK Consumer Healthcare, Inc. the distributor of Gas-X ® Extra strength. Distributed by: Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, PA 19087 IMPORTANT: Keep this carton for future reference on full labeling. Premier Value Extra Strength Simethicone
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 tablets contains: calcium 45 mg • store at room temperature • protect from excessive heat and moisture DO NOT USE IF ANY INDVIDUAL BLISTER IS BROKEN OR OPEN
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.Warning 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