NUROFEN COLD & FLU film coated tablet blister pack

Main information

  • Trade name:
  • NUROFEN COLD & FLU film coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NUROFEN COLD & FLU film coated tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 181936
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

181936

NUROFEN COLD & FLU PE tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Reckitt Benckiser Pty Ltd

Postal Address

PO Box 20097 World Square,Sydney, NSW, 2002

Australia

ARTG Start Date

7/04/2011

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. NUROFEN COLD & FLU PE tablets blister pack

Product Type

Single Medicine Product

Effective date

23/08/2016

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For the relief of the symptoms of colds and flu with associated congestion, including aches and pains, headache, fever, sore throat, runny nose, blocked

nose and sinuses.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

4, 6, 8, 10, 12, 16, 20, 24

Not Scheduled after consideration by Committee

30, 36, 40 or 48 tablets

(S2) Pharmacy Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

a yellow round biconvex tablet printed with an identifying logo in black on

one face

Active Ingredients

Ibuprofen

200 mg

Phenylephrine hydrochloride

5 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 07:32:34 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