Active Ingredient
Simethicone 180 mg
Simethicone Gel
FDA Label NDC 17714-076
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advance Pharmaceutical Inc. for the product Simethicone (NDC 17714-076). 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, purpose, uses, warnings, directions, other information, inactive ingredients, questions or comments, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiflatulent
Uses
relieves
- bloating
- pressure
- fullness commonly referred to as gas
Warnings
If pregnant or breast-feeding, ask a health professional before use.
Directions
- swallow 1 to 2 softgels as needed after meals and at bed time.
- do not exceed 6 tablets per day unless directed by a physician
Other Information
- store at room temperature 15-30 °C (59-86 °F)
- protect from moisture
Inactive Ingredients
FD&C Yellow #6, gelatin, glycerin, purified water, sorbitol
Questions Or Comments
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Call 631-981-4600, 8.30 am – 4.30 pm EST Monday - Friday
Package Label
Sime (Sime)
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