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Product NDC Code | 0067-6274 | ||||||
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Drug Name | Gas-x ultra strength antigas softgels |
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Type | Brand | ||||||
Pharm Class | Skin Barrier Activity [PE] | ||||||
Active Ingredients |
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Route | ORAL | ||||||
Dosage Form | CAPSULE, LIQUID FILLED | ||||||
RxCUI drug identifier | 252294, 860055 |
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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 softgel) Simethicone 180 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: swallow with water 1 or 2 softgels as needed after meals and at bedtime do not exceed 2 softgels 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 FD&C yellow 6, gelatin, glycerin, hypromellose, light mineral oil, mannitol, peppermint oil, purified water, sorbitol, soy lecithin, titanium dioxide
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 and bloating 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 Ultra Strength AntiGas Softgels Simethicone SILICON DIOXIDE FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED GLYCERIN HYPROMELLOSE, UNSPECIFIED LIGHT MINERAL OIL MANNITOL PEPPERMINT OIL WATER SORBITOL LECITHIN, SOYBEAN TITANIUM DIOXIDE DIMETHICONE DIMETHICONE opaque softgel with white print logo G;X;U
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 #1 DOCTOR RECOMMENDED BRAND NDC 0067-6274-50 Gas-X ® SIMETHICONE 180 mg/ ANTIGAS RELIEVES GAS FAST PRESSURE • BLOATING • DISCOMFORT ULTRA STRENGTH 50 SoftGels Gas-X ® Ultra Strength Softgels are concentrated to contain liquid gas-fighting medicine in a small softgel so they are easy to swallow, and there is no chalky taste. TAMPER EVIDENT FEATURE: Gas-X ® Ultra Strength Softgels are sealed in blister packets. Use only if the individual seal is unbroken. Gas-X ® Ultra Strength Softgels 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. 46177347 Gas-X Ultra Strength Softgels 50 count carton
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
Storage and handling
Information about safe storage and handling of the drug product.Other information store at a controlled room temperature 20-25°C (68-77°F) protect from heat and moisture
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