PANADOL CHILDREN 1 - 5 YEARS paracetamol 24 mg/mL oral suspension bottle (Strawberry - Colourfree)

Main information

  • Trade name:
  • PANADOL CHILDREN 1 - 5 YEARS paracetamol 24 mg/mL oral suspension bottle (Strawberry - Colourfree)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PANADOL CHILDREN 1 - 5 YEARS paracetamol 24 mg/mL oral suspension bottle (Strawberry - Colourfree)
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 178300
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

178300

PANADOL CHILDREN 1 - 5 YEARS paracetamol 24 mg/mL oral suspension bottle (Strawberry -

Colourfree)

ARTG entry for

Medicine Registered

Sponsor

GlaxoSmithKline Consumer Healthcare Australia Pty Ltd

Postal Address

Locked Bag 3,

Ermington, NSW, 2115

Australia

ARTG Start Date

10/12/2010

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. PANADOL CHILDREN 1 - 5 YEARS paracetamol 24 mg/mL oral suspension bottle (Strawberry - Colourfree)

Product Type

Single Medicine Product

Effective date

2/05/2019

Permitted Indications

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

For the temporary relief of fever and pain associated with teething, headache, earache, immunisation, symptoms of cold and flu.

Warnings

No Warnings included on Record

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Polyethylene

Terephthalate

18 Months

Store below 30

degrees Celsius

Child resistant closure

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

100mL

(S2) Pharmacy Medicine

200mL

(S2) Pharmacy Medicine

Components

1.

Dosage Form

Suspension

Route of Administration

Oral

Visual Identification

An opaque, white viscous suspension, with small white crystals dispersed

uniformly throughout the suspension.

Active Ingredients

paracetamol

24 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 23.05.2019 at 12:12:22 AEST

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