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Gas-x extra strength softgels - Medication Information

Product NDC Code 0067-6275
Drug Name

Gas-x extra strength softgels

Type Brand
Pharm Class Skin Barrier Activity [PE]
Active Ingredients
Dimethicone 125 mg/1
Route ORAL
Dosage Form CAPSULE, LIQUID FILLED
RxCUI drug identifier 198852,
210299
Application Number M001
Labeler Name Haleon US Holdings LLC
Packages
Package NDC Code Description
0067-6275-01 120 capsule, liquid filled in 1 carton (0067-6275-01)
0067-6275-10 1 blister pack in 1 carton (0067-6275-10) / 10 capsule, liquid filled in 1 blister pack
0067-6275-20 2 blister pack in 1 carton (0067-6275-20) / 10 capsule, liquid filled in 1 blister pack
0067-6275-30 3 blister pack in 1 carton (0067-6275-30) / 10 capsule, liquid filled in 1 blister pack
0067-6275-50 5 blister pack in 1 carton (0067-6275-50) / 10 capsule, liquid filled in 1 blister pack
0067-6275-72 6 blister pack in 1 carton (0067-6275-72) / 12 capsule, liquid filled in 1 blister pack
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each softgel) 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 and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime do not exceed 4 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 yellow no. 10, FD&C blue no. 1, FD&C red no. 40, gelatin, glycerin, hypromellose, mannitol, medium chain triglycerides, peppermint oil, propylene glycol, 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, 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 Softgels Simethicone D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN, UNSPECIFIED GLYCERIN HYPROMELLOSE, UNSPECIFIED MANNITOL MEDIUM-CHAIN TRIGLYCERIDES PEPPERMINT OIL PROPYLENE GLYCOL WATER SORBITOL LECITHIN, SOYBEAN TITANIUM DIOXIDE DIMETHICONE DIMETHICONE G;X

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 0067-6275-10 #1 DOCTOR RECOMMENDED BRAND Gas-X SIMETHICONE 125 mg / ANTIGAS RELIEVES GAS FAST PRESSURE – BLOATING – DISCOMFORT EXTRA STRENGTH G-X 10 SoftGels 62000000047349 – Front Carton Gas-X Extra Strength Soft Gel 10 SoftGels

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.
Additional information Gas-X Extra 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. READ ALL PRODUCT INFORMATION BEFORE USING. KEEP CARTON FOR IMPORTANT INFORMATION. Gas-X Extra Strength Softgels are concentrated to contain liquid gas-fighting medicine in a small softgels so they are easy to swallow, and there is no chalky taste. TAMPER EVIDENT FEATURE: Do not use if blister is broken or damaged. 1-855-328-5204 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.

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? 1-855-328-5204

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at controlled room temperature 20-25ºC (68-77ºF) 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.
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