Active Ingredient (In Each Capsule)
Simethicone 180 mg
Simethicone
FDA Label NDC 84328-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shandong Rosemed Biooharm Llc for the product Simethicone (NDC 84328-002). 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 capsule), purpose, uses, warnings, other information, directions, inactive ingredients, keep out of reach of children, 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
Warnings
Stop use and ask a doctorif condition persists
Keep out of reach of children.
Other Information
store at room temperature 59° - 86°F (15° - 30°C)
Directions
swallow one or two softgels as needed after a meal
do not exceed two softgels per day except under the advice and supervision of a physician
Inactive Ingredients
FD&C yellow#6, gelatin, glycerin, purified water and white edible ink
Keep Out Of Reach Of Children
Keep out of reach of children.
Package Label.Principal Display Panel
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