Rugby Gas Relief Tablet, Chewable
FDA Label NDC 0536-1223

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Rugby Gas Relief (NDC 0536-1223). 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 active ingredient(in each tablet), purpose, use(s), warnings, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(In Each Tablet)

Simethicone 125 mg

Purpose

Anti-gas

Use(S)

relieves:


  • pressure
  • bloating
  • symptoms referred to as gas

Warnings

.

Keep Out Of Reach Of Children

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

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

Other Information

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

Inactive Ingredients

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

Questions Or Comments?

1 (800) 645-2158

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN GAS-X® EXTRA STRENGTH*
NDC 0536-1223-08
Rugby
EXTRA STRENGTH
GAS
RELIEF
LACTOSE FREE
Simethicone 125 mg each
Antiflatulent

60 CHEWABLE TABLETS



131 (131)

131 (131)

* Please review the disclaimer below.