ADVIL

Main information

  • Trade name:
  • ADVIL PLUS capsule shaped tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ADVIL PLUS capsule shaped tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 184751
  • Last update:
  • 13-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

184751

ADVIL PLUS capsule shaped tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Pfizer Australia Pty Ltd

Postal Address

PO Box 57,WEST RYDE, NSW, 2114

Australia

ARTG Start Date

8/06/2011

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. ADVIL PLUS capsule shaped tablet blister pack

Product Type

Single Medicine Product

Effective date

8/06/2011

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Advil Plus Caplets are for the temporary relief of strong pain and acute pain where inflammation is present such as back pain, muscular pain, headache

(including migraine and tension headache), arthritic pain, rheumatic pain, neuralgic pain, period pain and dental pain. Reduces Fever.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PE/PVDC/Al

18 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S3) Pharmacist Only Medicine

(S3) Pharmacist Only Medicine

(S3) Pharmacist Only Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White film coated, capsule shaped biconvex tablet marked with Advil on

one side and the other side with "A" and "+" with a break bar

Active Ingredients

codeine phosphate hemihydrate

12.8 mg

Ibuprofen

200.005 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 04:28:33 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