TERRYWHITE

Main information

  • Trade name:
  • TERRYWHITE CHEMISTS ACID & HEARTBURN RELIEF EXTRA STRENGTH RANITIDINE 300 mg tablets (as hydrochloride) blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TERRYWHITE CHEMISTS ACID & HEARTBURN RELIEF EXTRA STRENGTH RANITIDINE 300 mg tablets (as hydrochloride) blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 193440
  • Last update:
  • 12-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

193440

TERRYWHITE CHEMISTS ACID & HEARTBURN RELIEF EXTRA STRENGTH RANITIDINE 300 mg

tablets (as hydrochloride) blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

23/12/2011

Product category

Medicine

Status

Active

Approval area

Non-Prescription Medicines

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. TERRYWHITE CHEMISTS ACID & HEARTBURN RELIEF EXTRA STRENGTH RANITIDINE 300 mg tablets (as

hydrochloride) blister pack

Product Type

Single Medicine Product

Effective date

7/10/2016

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Relief of symptoms of gastro-oesophageal reflux

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Not recorded

36 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S2) Pharmacy Medicine

(S2) Pharmacy Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Creamish yellow, round, biconvex film coated tablets marked "R 300" on

one side

Active Ingredients

Ranitidine hydrochloride

335 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 28.11.2017 at 06:44:45 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information