CIPLA

Main information

  • Trade name:
  • CIPLA COLD & FLU PE DAY paracetamol 500mg, phenylephrine hydrochloride 5mg & codeine phosphate hemihydrate 6mg tablets blister p
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CIPLA COLD & FLU PE DAY paracetamol 500mg, phenylephrine hydrochloride 5mg & codeine phosphate hemihydrate 6mg tablets blister p
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219457
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219457

CIPLA COLD & FLU PE DAY paracetamol 500mg, phenylephrine hydrochloride 5mg & codeine phosphate

hemihydrate 6mg tablets blister pack

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

22/01/2014

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. CIPLA COLD & FLU PE DAY paracetamol 500mg, phenylephrine hydrochloride 5mg & codeine phosphate

hemihydrate 6mg tablets blister pack

Product Type

Single Medicine Product

Effective date

22/01/2014

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Temporary relief of cold and flu symptoms including headache, body aches and pains, fever, nasal congestion and runny nose. Reduces fever.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/PE

24 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

12, 24, 36

(S2) Pharmacy Medicine

Components

1.

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

White to off white circular, flat, bevelled edge uncoated tablet, breakline on

one side and plain on other side.

Active Ingredients

codeine phosphate hemihydrate

6 mg

Paracetamol

500 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 26.11.2017 at 03:41:41 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