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Product NDC Code | 0067-0129 | ||||||||
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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 | M002 | ||||||||
Labeler Name | Haleon US Holdings LLC | ||||||||
Packages |
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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, D&C Yellow 10 aluminum lake, dextrose, flavors, maltodextrin, starch
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 Antigas
Spl product data elements
Usually a list of ingredients in a drug product.Gas-X Extra Strength Simethicone TRIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE D&C RED NO. 30 D&C YELLOW NO. 10 DEXTROSE, UNSPECIFIED FORM MALTODEXTRIN SOY PROTEIN DIMETHICONE DIMETHICONE Gas;X;ES Peppermint 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 0067-0129-48 #1 DOCTOR RECOMMENDED BRAND Gas-X® SIMETHICONE 125 mg /ANTIGAS RELIEVES GAS FAST Pressure • Bloating • Discomfort EXTRA STRENGTH PEPPERMINT CREME 48 Chewable Tablets Gas-X® Extra Strength Peppermint Creme chewable tablets have a pleasantly smooth, creamy mint flavor. Chewable tablets are also available in a great tasting Cherry Creme flavor. TAMPER EVIDENT FEATURE: Gas-X® tablets are sealed in blister packets. Use only if the individual seal is unbroken. Gas-X® Extra 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. 1-800-452-0051 www.Gas-X.com Distributed by: GSK Consumer Healthcare Warren, NJ 07059 Trademarks are owned by or licensed to the GSK group of companies. ©2016 GSK group of companies or its licensor. All rights reserved. 46176391 46176391_Gas-X ES Peppermint Creme 0129_48 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 1-800-452-0051
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