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Gas relief extra strength - Medication Information

Product NDC Code 36800-197
Drug Name

Gas relief extra strength

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
Application Number part347
Labeler Name TOP CARE (Topco Associates LLC)
Packages
Package NDC Code Description
36800-197-30 30 blister pack in 1 carton (36800-197-30) / 1 capsule, liquid filled in 1 blister pack
36800-197-50 50 blister pack in 1 carton (36800-197-50) / 1 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: 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 physican

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, mannitol, peppermint oil, purified water, sorbitan, sorbitol, 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.
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 Relief Extra Strength Simethicone DIMETHICONE DIMETHICONE D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN GLYCERIN PEPPERMINT OIL WATER SORBITAN SORBITOL TITANIUM DIOXIDE MANNITOL PO

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 COMPARE TO THE ACTIVE INGREDIENT IN GAS-X® EXTRA STRENGTH† EXTRA STRENGTH Gas Relief ANTI-GAS/SIMETHICONE 125 mg FAST RELIEF OF: Bloating Pressure fullness & Gas SOFTGELS †This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Gas-X Extra Strength. TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 [email protected] www.topcarebrand.com Product Label TOPCARE HEALTH Gas Relief Simethicone 125 mg

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 toll free 1-888-423-0139

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health professional before use.

Storage and handling

Information about safe storage and handling of the drug product.
Other information store between 20-25°C (68-77°F) do not refrigerate 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 If pregnant or breast-feeding, ask a health professional before use. 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

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