MEDREICH

Main information

  • Trade name:
  • MEDREICH PARACETAMOL EXTRA film coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MEDREICH PARACETAMOL EXTRA film coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 211594
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

211594

MEDREICH PARACETAMOL EXTRA film coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Medreich Australia Pty Ltd

Postal Address

PO Box 6549,SILVERWATER, NSW, 1811

Australia

ARTG Start Date

1/07/2013

Product category

Medicine

Status

Active

Approval area

Non-Prescription Medicines

Products

1. MEDREICH PARACETAMOL EXTRA film coated tablet blister pack

Product Type

Single Medicine Product

Effective date

1/07/2013

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For the temporary relief of pain and discomfort associated with headache, tension headache, migraine headache, osteoarthritis, arthritis, cold & flu

symptoms, toothache, dental procedures, muscular aches, sore throat and period pain. Reduces fever.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

3 Years

Store below 30

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

10,18,36,64,72

(S2) Pharmacy Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off white caplet shaped, biconvex film coated tablets debossed

with '65' on one side and '500' opn the otherside.

Active Ingredients

Caffeine

65 mg

Paracetamol

500 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 27.11.2017 at 01:17:44 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

5-6-2018

FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products

FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products

FDA issued warning letters to the parties responsible for liquidcaffeine.com and Dual Health Body and Mind for illegally selling certain highly concentrated caffeine products.

FDA - U.S. Food and Drug Administration

16-1-2018

Yunnan Feng Shi Ling capsules – counterfeit

Yunnan Feng Shi Ling capsules – counterfeit

Yunnan Feng Shi Ling capsules contain the undeclared substance paracetamol.

Therapeutic Goods Administration - Australia

27-2-2014

Paracetamol use during pregnancy

Paracetamol use during pregnancy

A new Danish study suggests a possible connection between mothers' use of paracetamol painkillers during pregnancy and the risk of developing disorders like ADHD (attention deficit hyperactivity disorder) in children.

Danish Medicines Agency

3-8-2012

Danish Pharmacovigilance Update, 21 June 2012

Danish Pharmacovigilance Update, 21 June 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Decrease in the number of intoxications and suicide attempts using drugs containing acetylsalicylic acid or paracetamol.

Danish Medicines Agency

30-8-2018

Consultation: Referral of proposed amendment to the current Poisons Standard to the meeting of the ACMS, March 2019

Consultation: Referral of proposed amendment to the current Poisons Standard to the meeting of the ACMS, March 2019

Advisory Committee on Medicines Scheduling to consider upscheduling of modified release paracetamol to 'Pharmacist Only'. Closing date 31 October 2018

Therapeutic Goods Administration - Australia

30-8-2018

Modified release paracetamol

Modified release paracetamol

Advisory Committee on Medicines Scheduling to consider upscheduling of modified release paracetamol to 'Pharmacist Only'

Therapeutic Goods Administration - Australia