Active Ingredient (In Each Softgel)
Simethicone 180 mg
Simethicone 180 Mg Capsule, Liquid Filled
FDA Label NDC 85786-401
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Farmacias De Similares Tx Llc for the product Simethicone 180 Mg (NDC 85786-401). 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, warnings, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiflatulent (antigas)
Uses
Relieves - bloating - pressure -fullness commonly referred to as gas
Warnings
Warnings
Stop Use And Ask A Doctor If
condition persists.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
Keep out of reach of children.
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.
Other Information
Store at 15-30°C (59-86°F)
Inactive Ingredients
Black iron oxide, FD&C Yellow No. 6, Gelatin, Glycerin, Peppermint oil, Sorbitol, Titanium dioxide.
Questions Or Comments?
(855)-280-1079
Other
* This product is not affiliated with the owner of the trademark Ultra Strength Phazyme®.
Distributed in USA by: FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA
[email protected] www.drsimi.com
Package Label.Principal Display Panel
Dr. Simi
Compare to the active ingredient in Ultra Strength Phazyme®*
NDC: 85786-401-24
Simethicone 180 mg
Antigas
Relieves pressure, bloating & fullness.
24 Softgels
* Please review the disclaimer below.
