Extra Strength Gas Relief Simethicone 125 Mg
FDA Label NDC 11673-415

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Target Corporation for the product Extra Strength Gas Relief Simethicone 125 Mg (NDC 11673-415). 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 drug facts, active ingredient (in each softgel), purpose, use, 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

Drug Facts

Active Ingredient (In Each Softgel)

Simethicone 125 mg

Purpose

Antigas

Use

for the relief of

  • pressure, bloating, and fullness commonly referred to as gas

Directions

adults:

  • swallow with water 1 or 2 softgels as needed after meals and at bedtime.
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician.

Other Information

  • store at controlled room temperature 20°-25°C (68°-77°F)
  • protect from light, heat, and moisture

Inactive Ingredients

FD&C blue#1, FD&C yellow#10, gelatin, glycerin, peppermint oil, povidone,
purified water, sorbitol sorbitan, titanium dioxide

Questions Or Comments?

1-888-333-9792

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This product is not manufactured or distributed by GlaxoSmithKline, owner of the
registered trademark Extra Strength Gas-X®.

Distributed by Target Corporation
Minneapolis, MN 55403
Made in India
TM & ©2022 Target Brands, Inc.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
KEEP OUTER CARTON FOR COMPLETE WARNINGS
AND PRODUCT INFORMATION

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