AMCAL

Main information

  • Trade name:
  • AMCAL CHILDREN'S PARACETAMOL SUSPENSION FOR 6 TO 12 YEARS paracetamol 48 mg/mL oral liquid bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AMCAL CHILDREN'S PARACETAMOL SUSPENSION FOR 6 TO 12 YEARS paracetamol 48 mg/mL oral liquid bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219534
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219534

AMCAL CHILDREN'S PARACETAMOL SUSPENSION FOR 6 TO 12 YEARS paracetamol 48 mg/mL oral

liquid bottle

ARTG entry for

Medicine Registered

Sponsor

Cipla Australia Pty Ltd

Postal Address

Level 1 / 132-136 Albert Road,SOUTH MELBOURNE, VIC, 3205

Australia

ARTG Start Date

23/01/2014

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. AMCAL CHILDREN'S PARACETAMOL SUSPENSION FOR 6 TO 12 YEARS paracetamol 48 mg/mL oral liquid

bottle

Product Type

Single Medicine Product

Effective date

23/01/2014

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For effective temporary relief of fever and pain associated with immunisation, earache, headache, symptoms of colds and flu.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

2 Years

Store below 25

degrees Celsius

Not recorded

Do not Refrigerate

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

200mL

(S2) Pharmacy Medicine

Components

1.

Dosage Form

Oral Liquid, suspension

Route of Administration

Oral

Visual Identification

White to off white uniform suspension with characteristic flavour

Active Ingredients

Paracetamol

48 mg/mL

© 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 26.11.2017 at 03:38:53 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

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