Drugplain

TopCare health EXTRA STRENGTH Gas Relief SOFTGEL 125 mg/1

Simethicone · CAPSULE, LIQUID FILLED · Topco Associates LLC

No Recall History
Plain English

TopCare health EXTRA STRENGTH Gas Relief SOFTGEL is a capsule, liquid filled containing simethicone at 125 mg/1, taken oral. Manufactured by Topco Associates LLC.

Key Facts

Brand Name
TopCare health EXTRA STRENGTH Gas Relief SOFTGEL
Generic Name
Simethicone
NDC Code (Product)
76162-538
Manufacturer
Topco Associates LLC
Strength
125 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
M002
Marketing Start
08/01/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea106 reports
fatigue83 reports
diarrhoea79 reports
vomiting70 reports
abdominal pain67 reports
dyspnoea66 reports
pain58 reports
pyrexia58 reports
anaemia56 reports
asthenia52 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for the relief of Pressure, bloating, and fullness commonly referred to as gas

Dosage & Administration

Directions adults and children 12 years and older: 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

Warnings

Warnings Keep out of reach of children.

Frequently Asked Questions

What is TopCare health EXTRA STRENGTH Gas Relief SOFTGEL used for?

TopCare health EXTRA STRENGTH Gas Relief SOFTGEL contains Simethicone. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.

Is TopCare health EXTRA STRENGTH Gas Relief SOFTGEL a controlled substance?

TopCare health EXTRA STRENGTH Gas Relief SOFTGEL is not classified as a controlled substance by the DEA.

What is the generic name for TopCare health EXTRA STRENGTH Gas Relief SOFTGEL?

The generic name for TopCare health EXTRA STRENGTH Gas Relief SOFTGEL is Simethicone. There are 12 other brand versions of Simethicone.

What is the NDC code for TopCare health EXTRA STRENGTH Gas Relief SOFTGEL 125 mg/1?

The NDC (National Drug Code) for TopCare health EXTRA STRENGTH Gas Relief SOFTGEL 125 mg/1 is 76162-538, listed by Topco Associates LLC.