Drugplain

Gas Relief 125 mg/1

Simethicone · TABLET, CHEWABLE · Heartland Pharma Co.

3 Recalls on Record
Plain English

Gas Relief is a tablet, chewable containing simethicone at 125 mg/1, taken oral. Manufactured by Heartland Pharma Co..

Key Facts

Brand Name
Gas Relief
Generic Name
Simethicone
NDC Code (Product)
80136-859
Manufacturer
Heartland Pharma Co.
Strength
125 mg/1
Dosage Form
TABLET, CHEWABLE
Route
ORAL
Marketing Status
Application #
M002
Marketing Start
06/30/2023

Recall History

3 Recalls on Record
Class II09/18/2019

GCP Laboratories Inc

Microbial Contamination of Non-Sterile Product.

TerminatedVoluntary: Firm initiated
Class II03/07/2019

Medtech Products, Inc.

Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.

TerminatedVoluntary: Firm initiated
Class II05/28/2024

Denison Pharmaceuticals, LLC

cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

fatigue4,908 reports
nausea4,355 reports
off label use4,174 reports
pain4,093 reports
dyspnoea3,903 reports
diarrhoea3,824 reports
drug ineffective3,784 reports
vomiting3,699 reports
pneumonia3,243 reports
headache3,215 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses For the relief of pressure and bloating commonly referred to as gas

Dosage & Administration

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

Warnings

Warnings If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

Frequently Asked Questions

What is Gas Relief used for?

Gas Relief contains Simethicone. It is a tablet, chewable taken oral. Consult your doctor for specific uses.

Is Gas Relief a controlled substance?

Gas Relief is not classified as a controlled substance by the DEA.

What is the generic name for Gas Relief?

The generic name for Gas Relief is Simethicone. There are 9 other brand versions of Simethicone.

What is the NDC code for Gas Relief 125 mg/1?

The NDC (National Drug Code) for Gas Relief 125 mg/1 is 80136-859, listed by Heartland Pharma Co..