CHEMISTS' OWN COUGH, COLD & FLU DAY/NIGHT tablet blister pack

Australia - English - Department of Health (Therapeutic Goods Administration)

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Active ingredient:
chlorphenamine maleate,dextromethorphan hydrobromide monohydrate,paracetamol,pseudoephedrine hydrochloride
Available from:
Aspen Pharma Pty Ltd
INN (International Name):
chlorphenamine maleate,dextromethorphan hydrobromide monohydrate,Paracetamol,Pseudoephedrine hydrochloride
Authorization status:
Registered
Authorization number:
293383

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Public Summary

Summary for ARTG Entry:

293383

CHEMISTS' OWN COUGH, COLD & FLU DAY/NIGHT tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Aspen Pharma Pty Ltd

Postal Address

34-36 Chandos Street,ST LEONARDS, NSW, 2065

Australia

ARTG Start Date

30/08/2017

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. CHEMISTS' OWN COUGH, COLD & FLU DAY/NIGHT tablet blister pack

Product Type

Composite Pack

Effective date

30/08/2017

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Provides fast and effective relief from the symptoms of cold and flu. The non-drowsy Day tablet temporarily relieves: blocked noses, runny noses,

nagging cough, headaches, body aches and pains, and fever. The Night tablet contains an antihistamine and temporarily relieves: blocked noses,

headaches, body aches and pains, and fever.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Multiple containers

Not recorded

3 Years

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

6 night tablets

(S3) Pharmacist Only Medicine

18 day tablets

(S3) Pharmacist Only Medicine

Components

1. Night tablet

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Pale blue film coated round plain tablet with a break bar

Active Ingredients

chlorphenamine maleate

2 mg

Paracetamol

500 mg

Pseudoephedrine hydrochloride

30 mg

2. Day tablet

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Pale yellow film coated round plain tablet with a break bar

Active Ingredients

dextromethorphan hydrobromide monohydrate

15 mg

Paracetamol

500 mg

Pseudoephedrine hydrochloride

30 mg

Public Summary

Page 1 of

Produced at 24.11.2017 at 06:24:05 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 24.11.2017 at 06:24:05 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

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