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| Product NDC Code | 0067-0117 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Gas-x 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 | 210295, 314221 |
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| Application Number | part332 | ||||||||||||
| Labeler Name | GlaxoSmithKline Consumer Healthcare Holdings (US) 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 or 2 tablets as needed after meals and at bedtime • do not exceed 4 tablets in 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 calcium phosphate tribasic, colloidal silicon dioxide, D&C Red 30 aluminum lake, dextrose, flavors, maltodextrin, propylene glycol, soy protein isolate
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.Use for the relief of • pressure, bloating, and fullness commonly 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-X Extra Strength Simethicone DIMETHICONE DIMETHICONE TRIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE D&C RED NO. 30 DEXTROSE, UNSPECIFIED FORM MALTODEXTRIN PROPYLENE GLYCOL SOY PROTEIN Gas;X;ES Cherry 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 NDC 0067-0117-01 #1 DOCTOR RECOMMENDED BRAND Gas-X SIMETHICONE 125 mg /ANTIGAS RELIEVES GAS FAST Pressure • Bloating • Discomfort EXTRA STRENGTH CHERRY CREME 72 Chewable Tablets Gas-X Extra Strength Cherry Creme chewable tablets have a pleasantly smooth, creamy cherry flavor. Chewable tablets are also available in a great tasting Peppermint Creme flavor. TAMPER EVIDENT FEATURE: Gas-X tablets are sealed in blister packets. Use only if the individual seal is unbroken. Gas-XExtra Strength Tablets offer fast, effective relief of pressure and bloating that antacids can’t provide. They are specially formulated with simethicone, the antigas medicine doctors recommend most for pressure, bloating or discomfort referred to as gas. Distributed by: GSK Consumer Healthcare Warren, NJ 07059 Trademarks are owned by or licensed to the GSK group of companies. ©2017 GSK group of companies or its licensor. 62000000017642 Gas-X ES Cherry Creme 0117_72 ct.JPG
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other information • each tablet contains: calcium 45 mg • store at controlled room temperature 20-25°C (68-77°F) • protect from moisture
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? call 1-855-328-5204
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.
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