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Product NDC Code | 0067-6283 | ||||||
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Drug Name | Gas-x maximum strength 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 | 412111, 2119393 |
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Application Number | M001 | ||||||
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 250 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 and children 12 years and older: 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 D&C red no. 33, FD&C blue no. 1, gelatin, glycerin, lecithin, purified water, 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, 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 Maximum Strength Softgels Simethicone D&C RED NO. 33 FD&C BLUE NO. 1 GELATIN, UNSPECIFIED GLYCERIN LECITHIN, SOYBEAN WATER TITANIUM DIOXIDE DIMETHICONE DIMETHICONE opaque softgel with white print logo GXM
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 NEW #1 DOCTOR RECOMMENDED BRAND NDC 0067-6283-02 Gas-X SIMETHICONE 250 mg/ ANTIGAS Goes to work in Minutes RELIEVES GAS FAST PRESSURE • BLOATING • DISCOMFORT MAXIMUM STRENGTH 50 SoftGels Gas-X Maximum 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: Do not use if blister is broken or damaged. 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. 1-800-328-5204 www.Gas-X.com Distributed by: GSK Consumer Healthcare Warren, NJ 07059 ©2020 GSK group of companies or its licensor. Trademarks are owned by or licensed to the GSK group of companies. 1000610 1000610 GSX Maximum Strength 50 softgels
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 1-800-328-5204
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 light 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