Active Ingredient (In Each Softgel)
Simethicone 180 mg
Ultra Strength Gas Relief
FDA Label NDC 69618-045
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reliable 1 Laboratories Llc for the product Ultra Strength Gas Relief (NDC 69618-045). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each softgel), purpose, uses, directions, other information, inactive ingredients, questions or comments?, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-gas
Uses
- relieves bloating, pressure or fullness commonly referred to as gas
Directions
- swallow 1 or 2 softgels as needed after a meal
- do not exceed two softgels per day except under the advice and supervision of a physician
Other Information
- store at room temperature 59° - 86°F (15° - 30°C)
Inactive Ingredients
FD&C yellow#6, gelatin, glycerin, purified water and white edible ink
Questions Or Comments?
Call: 516-341-0666
Principal Display Panel
Ultra Strength Gas Relief
Simethicone 180 mg Anti-gas 180 Softgels
NDC 69618-045-18
*Compare to the active ingredient in PHAZYME® Ultra Strength
* Please review the disclaimer below.
