Maximum Strength Gas Relief
FDA Label NDC 68210-4165

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Maximum Strength Gas Relief (NDC 68210-4165). 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, use, stop use and ask a doctor if, 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

Active Ingredient (In Each Softgel)

Simethicone 250 mg

Purpose

Anti-gas

Use

  • relieves bloating, pressure or fullness commonly referred to as gas

Stop Use And Ask A Doctor If

condition persists

Directions

  • swallow one or two softgels after a meal
  • do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other Information

  • store at room temperature 59°-86°F (15°-30°C)

Inactive Ingredients

D&C Red #33, FD&C Blue #1, gelatin, glycerin, povidone, purified water, sorbitol sorbitan, titanium dioxide

Questions Or Comments?

1-888-333-9792

Principal Display Panel

VALUMEDS MAXIMUM STRENGTH GAS RELIEF

SIMETHICONE 250 mg/  Anti-gas

Compare to the active ingredient in PHAZYME® Maximum Strength*

*This product is not manufactured or distributed by C.B.
Fleet Company Inc., distributor of PHAZYME®.

70 SOFTGELS

* Please review the disclaimer below.