Faulding Cold + Flu Defence

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

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Active ingredient:
ascorbic acid,Allium sativum,Echinacea purpurea,Olea europaea,zinc citrate dihydrate
Available from:
Endeavour CH Pty Ltd
Authorization status:
Listed
Authorization number:
323980

Public Summary

Summary for ARTG Entry:

323980

Faulding Cold + Flu Defence

ARTG entry for

Medicine Listed

Sponsor

Endeavour CH Pty Ltd

Postal Address

Endeavour Consumer Health,Level 7 737 Bourke St,Docklands, VIC, 3008

Australia

ARTG Start Date

24/09/2019

Product category

Medicine

Status

Active

Approval area

Listed Medicines

Conditions

Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Act, shall be only those included in

the list of 'Colourings permitted in medicines for oral use'.

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine,

(b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is

sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be

kept.

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records

to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request.

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted

in relation to the inclusion of the medicine in the Register.

All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Office

of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors

of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notified

of the report or reports.

The sponsor shall not supply the listed medicine after the expiry date of the goods.

Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine

outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National

Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor.

Products

1. Faulding Cold + Flu Defence

Product Type

Single Medicine Product

Effective date

24/09/2019

Permitted Indications

Antioxidant/Reduce free radicals formed in the body

Helps reduce/decrease free radical damage to body cells

Traditionally used in Western herbal medicine to alterative/blood cleanser/depurative/purifier

Traditionally used in Western herbal medicine to sudorific/diaphoretic/enhance/promote sweating/perspiration

Traditionally used in Western herbal medicine to maintain/support general health and wellbeing

Maintain/support general health and wellbeing

Traditionally used in Western herbal medicine to antipyretic/febrifuge/relieve mild fever/reduce body temperature/body cooling

Maintain/support immune system health

Maintain/support healthy immune system function

Helps prevent dietary (state vitamin/mineral/nutrient) deficiency when dietary intake is inadequate

Traditionally used in Western herbal medicine to decrease/reduce/relieve symptoms of common colds and flu

Traditionally used in Western herbal medicine to decrease/reduce/relieve the severity of symptoms of mild upper respiratory tract infections

Traditionally used in Western herbal medicine to expectorant/clear respiratory tract mucous

Indication Requirements

Product presentation must not imply or refer to serious immunological diseases.

Product presentation must not imply or refer to drugs/alcohol.

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to serious forms of respiratory disorders/diseases, such as: asthma, pneumonia, COAD, COPD, influenza.

Label statement: Vitamins and minerals can only be of assistance if dietary intake is inadequate OR Vitamin and/or mineral supplements should not

replace a balanced diet.

Public Summary

Page 1 of

Produced at 29.09.2019 at 04:11:47 AEST

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

Respiratory tract infections must be qualified by 'mild'.

Label statement: Adults only, OR Not to be used in children under 2 years of age without medical advice.

Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.

Product presentation must only refer to detoxification in relation to natural body processes.

Label statement: Not to be used in children under 5 years.

Standard Indications

No Standard Indications included on Record

Specific Indications

Warnings

Adults only. OR Not to be used in children under two years of age without medical advice (or words to that effect).

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

Allium sativum

200 mg

Equivalent: Allium sativum (Dry)

ascorbic acid

50 mg

Echinacea purpurea

166.67 mg

Equivalent: Echinacea purpurea (Dry)

Olea europaea

625 mg

Equivalent: Olea europaea (Dry)

6.25 g

zinc citrate dihydrate

16 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 2 of

Produced at 29.09.2019 at 04:11:47 AEST

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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