Otc - Active Ingredient
Simethicone 180mg
Simethicone Capsule, Liquid Filled
FDA Label NDC 73629-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amz789 Llc for the product Simethicone (NDC 73629-002). 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 otc - active ingredient, otc - purpose, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, indications & usage, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
relieves bloating, pressure, fullness, commonly referred to as gas
Otc - Stop Use
stop use and ask a doctor if condition persists
Otc - Pregnancy Or Breast Feeding
if pregnant or breast-feedingm ask a health professional before use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Dosage & Administration
▪ 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
Indications & Usage
Uses relieves ▪ bloating ▪ pressure ▪ fullness commonly referred to as gas
Inactive Ingredient
FD&C yellow #6, gelatin, glycerin, purified water, sorbitol
Package Label.Principal Display Panel
RxZell
Fast Acting Gas Relief
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