Rugby Gas relief

SIMETHICONE ORAL HUMAN OTC DRUG

Rugby Gas relief is an FDA drug label for the active ingredient SIMETHICONE manufactured by Rugby Laboratories administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260504.

Generic name
SIMETHICONE
Manufacturer
Rugby Laboratories
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
0536-1223
Application
M016
Label effective
20260504

About this product

Rugby Gas relief is an FDA-registered drug product whose active ingredient is SIMETHICONE. It is labelled by Rugby Laboratories taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 0536-1223, application M016, label effective 20260504. It is one of 57 FDA drug label records sharing the active ingredient SIMETHICONE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing SIMETHICONE are most often described in connection with: relieves pressure, bloating symptoms, referred gas. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

ACTIVE INGREDIENT(in each tablet) Simethicone 125 mg

Indications & Usage

USE(S) relieves: pressure bloating symptoms referred to as gas

Dosage & Administration

DIRECTIONS chew 1 to 2 tablets thoroughly as needed after meals and at bedtime do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician

Warnings

WARNINGS .

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How products containing SIMETHICONE compare

FDA lists 57 drug label records with SIMETHICONE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Allegiant Health 3
— — Advance Pharmaceutical Inc. 2
— — BEST CHOICE (VALU MERCHANDISERS COMPANY) 2
— — C.B. Fleet Company, Inc. 2
— — CVS 2

Recall and safety notices

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-0010-2026 Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-61, UPC (01)00309047130610 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories Class II Ongoing 20251015
D-0009-2026 Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UPC (01)00309047130061 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories Class II Ongoing 20251015
D-0013-2026 Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61, UPC (01)00309047133611 NDC 0904-7133-61 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories Class II Ongoing 20251015
D-0011-2026 Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61, UPC (01)00309047131617 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories Class II Ongoing 20251015
D-0012-2026 Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7132-61, UPC (01)00309047132614 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories Class II Ongoing 20251015

Frequently asked questions

What is Rugby Gas relief used for?
USE(S) relieves: pressure bloating symptoms referred to as gas

Who makes Rugby Gas relief?
Rugby Laboratories is the labeler of record for Rugby Gas relief. 57 FDA label records share the active ingredient SIMETHICONE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Rugby Gas relief come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Rugby Gas relief prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing SIMETHICONE?
Yes. 57 FDA drug label records list SIMETHICONE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Rugby Gas relief been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.