ADVIL CHILDREN 7-12 YEARS PAIN & FEVER RELIEF ibuprofen 100 mg chewable tablet bottle

Main information

  • Trade name:
  • ADVIL CHILDREN 7-12 YEARS PAIN & FEVER RELIEF ibuprofen 100 mg chewable tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ADVIL CHILDREN 7-12 YEARS PAIN & FEVER RELIEF ibuprofen 100 mg chewable tablet bottle
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 178662
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

178662

ADVIL CHILDREN 7-12 YEARS PAIN & FEVER RELIEF ibuprofen 100 mg chewable tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Pfizer Australia Pty Ltd

Postal Address

PO Box 57,WEST RYDE, NSW, 2114

Australia

ARTG Start Date

23/12/2010

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. ADVIL CHILDREN 7-12 YEARS PAIN & FEVER RELIEF ibuprofen 100 mg chewable tablet bottle

Product Type

Single Medicine Product

Effective date

9/06/2017

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For the temporary relief of pain and discomfort associated with common colds and flu, sore throat, earache, headache, toothache, body aches and pains,

sprains and strains. Reduces Fever.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

24 Months

Store below 25

degrees Celsius

Child resistant closure

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S2) Pharmacy Medicine

Not Scheduled after consideration by Committee

Components

1.

Dosage Form

Tablet, chewable

Route of Administration

Oral

Visual Identification

Round flat-faced bevelled edged tablets, mottled blue, engraved 'Advil 100'

on one side and scored one line on the other side

Active Ingredients

Ibuprofen

100 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 29.11.2017 at 10:10:57 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