FDA.reportPublic FDA data

Rugby Gas Relief Chewable Tablets

Manufacturer
Rugby Laboratories | Guardian Drug Company
Effective date
2024-12-04
Label type
Human OTC Drug Label
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:47:39

Label at a glance#

ProductRugby Gas relief
Active ingredientDIMETHICONE
Label structure10 sections

Dosage and administration

chew 2 to 4 tablets thoroughly as needed after meals and at bedtime do not exceed 6 tablets per day unless directed by a physician

Storage and handling

do  not use if inner seal is broken store at room temperature avoid high humidity and excessive heat, above 40 o C (104 o F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 80 mg

PURPOSE

OTC - PURPOSE SECTION

Antigas

USE(S)

INDICATIONS & USAGE SECTION

relieves:


  • pressure
  • bloating
  • symptoms referred to as gas

WARNINGS

WARNINGS SECTION

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately. 

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center immediately. 

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • chew 2 to 4 tablets thoroughly as needed after meals and at bedtime
  • do not exceed 6 tablets per day unless directed by a physician

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • do  not use if inner seal is broken
  • store at room temperature
  • avoid high humidity and excessive heat, above 40oC (104oF)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

1 (800) 645-2158

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0536-1207-04
Rugby
GAS
RELIEF
LACTOSE FREE
Simethicone 80 mg each
ANTIFLATULENT

100 CHEWABLE TABLETS

103103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1207RUGBY GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [RUGBY LABORATORIES]4Legacy NDC20241206_7cc926e0-452e-4c8d-9d06-970b761066bb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1207-04EA - Each0536-12071f335ecc-38a4-42ff-898c-d73fb0cc249212019-05-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-12070536-1207-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
SUGARCANE81H2R5AOH3IACT
MALTODEXTRIN7CVR7L4A2DIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
572d2972-24c3-426d-8764-97fc8e1bc8757cc926e0-452e-4c8d-9d06-970b761066bb2025-08-21WarningsExact identifier
spl set id: 7cc926e0-452e-4c8d-9d06-970b761066bb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.