PHARMACY

Main information

  • Trade name:
  • PHARMACY ACTION Cold & Flu Relief PE Day & Night tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PHARMACY ACTION Cold & Flu Relief PE Day & Night tablets blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 208283
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

208283

PHARMACY ACTION Cold & Flu Relief PE Day & Night tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Generic Health Pty Ltd

Postal Address

Level 1 / 1102 Toorak Road,CAMBERWELL, VIC, 3124

Australia

ARTG Start Date

17/04/2013

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. PHARMACY ACTION Cold & Flu Relief PE Day & Night tablets blister pack

Product Type

Composite Pack

Effective date

12/05/2015

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For the temporary relief from symptoms of colds and flu, including runny nose, nasal congestion, headache and body achies and pains. Reduces fever.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Multiple containers

Not recorded

2 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S2) Pharmacy Medicine

(S2) Pharmacy Medicine

Components

1. DAY TABLET

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

white to off-white, caplet shaped, film coated tablets with a breakline on one

side and "D" debossed on the other side

Active Ingredients

codeine phosphate hemihydrate

9.5 mg

Paracetamol

500 mg

Phenylephrine hydrochloride

5 mg

2. NIGHT TABLET

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Light pink coloured, film coated biconvex, caplet shaped tablets plain on

one side and breakline on other side

Active Ingredients

chlorphenamine maleate

2 mg

Paracetamol

500 mg

Phenylephrine hydrochloride

5 mg

Public Summary

Page 1 of

Produced at 27.11.2017 at 11:13:34 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

© 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 2 of

Produced at 27.11.2017 at 11:13:34 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