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| Product NDC Code | 36800-197 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Gas relief extra strength |
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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 | ||||||
| Application Number | M016 | ||||||
| Labeler Name | TOP CARE (Topco Associates LLC) | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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 feedingIf 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