Drugplain

Rugby 500 mg/1

Antacid Tablets · TABLET, CHEWABLE · Rugby Laboratories

10 Recalls on Record
Plain English

Rugby Antacid Tablets are chewable tablets containing 500 mg of antacid per tablet that you can take by mouth to relieve heartburn, acid indigestion, and upset stomach. This is an over-the-counter medication available without a prescription.

Key Facts

Brand Name
Rugby
Generic Name
Antacid Tablets
NDC Code (Product)
0536-1048
Manufacturer
Rugby Laboratories
Strength
500 mg/1
Dosage Form
TABLET, CHEWABLE
Route
ORAL
Marketing Status
Application #
M001
Marketing Start
12/24/2012

Recall History

10 Recalls on Record
Class II09/11/2024

Zhejiang Jingwei Pharmaceutical Co., Ltd.

Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.

OngoingVoluntary: Firm initiated
Class II05/21/2019

Torrent Pharma Inc

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated
Class II05/21/2019

Torrent Pharma Inc

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated
Class II08/16/2017

Pharmatech LLC

Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination

TerminatedVoluntary: Firm initiated
Class II08/16/2017

Pharmatech LLC

Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination

TerminatedVoluntary: Firm initiated
Class II08/08/2016

Pharmatech LLC

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

TerminatedVoluntary: Firm initiated
Class II05/21/2019

Torrent Pharma Inc

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated
Class I07/15/2016

The Harvard Drug Group

Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia

TerminatedVoluntary: Firm initiated
Class III11/12/2021

Dr. Reddy's Laboratories, Inc.

Failed dissolution specifications

TerminatedN/A
Class II08/02/2017

The Harvard Drug Group

Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

fatigue73,605 reports
nausea66,753 reports
drug ineffective64,445 reports
diarrhoea61,188 reports
dyspnoea59,728 reports
off label use57,546 reports
headache52,229 reports
pain51,706 reports
dizziness46,382 reports
vomiting45,090 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses washes the eye to help relieve irritation discomfort burning stinging itching by removing loose foreign material air pollutants (smog or pollen) chlorinated water

Dosage & Administration

Directions For use with nozzle applicator flush the affected eye(s) as needed control the rate of flow of solution by pressure on the bottle do not touch dropper tip to eye When using an eye cup rinse the cup with Eye Wash Solution immediately before each use avoid contamination of the rim and inside surfaces of the cup fill the cup half full with Eye Wash Solution and apply the cup to the affected eye(s), pressing tightly to prevent spillage tilt the head backward. Open eyelids wide and rotate eyeball to thoroughly wash the eye rinse cup with clean water after each use replace cap after use

Warnings

Warnings For external use only Do not use if you have open wounds in or near the eyes, and get medical help right away if solution changes color or becomes cloudy When using this product remove contact lenses before using do not touch the tip of container to any surface to avoid contamination replace cap after each use Stop use and ask a doctor if • you experience eye pain, changes in vision, continued redness or irritation of the eye • condition worsens or persists Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Frequently Asked Questions

What is Rugby used for?

Rugby Antacid Tablets are chewable tablets containing 500 mg of antacid per tablet that you can take by mouth to relieve heartburn, acid indigestion, and upset stomach. This is an over-the-counter medication available without a prescription.

Is Rugby a controlled substance?

Rugby is not classified as a controlled substance by the DEA.

What is the generic name for Rugby?

The generic name for Rugby is Antacid Tablets. There are 11 other brand versions of Antacid Tablets.

What is the NDC code for Rugby 500 mg/1?

The NDC (National Drug Code) for Rugby 500 mg/1 is 0536-1048, listed by Rugby Laboratories.