Oriental Botanicals Cold & Flu

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

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Active ingredient:
Andrographis paniculata,Echinacea purpurea,forsythia suspensa,Isatis tinctoria,Lonicera japonica,Magnolia liliflora,Platycodon grandiflorus,Schizonepeta tenuifolia
Available from:
McPherson's Consumer Products Pty Ltd
Authorization status:
Listed
Authorization number:
350168

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Public Summary

Summary for ARTG Entry:

350168

Oriental Botanicals Cold & Flu

ARTG entry for

Medicine Listed

Sponsor

Global Therapeutics Pty Ltd

Postal Address

Unit 1 Level 1, 85 O'Riordan Street, Alexandria, NSW, 2015

Australia

ARTG Start Date

30/11/2020

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.

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 . Oriental Botanicals Cold & Flu

Product Type

Single Medicine Product

Effective Date

30/11/2020

Permitted Indications

Traditionally used in Western herbal medicine to maintain/support immune system to fight illness

Traditionally used in Western herbal medicine to decrease/reduce/relieve common cold duration

Decrease/reduce/relieve symptoms of common colds and flu

Linked indication - Relieve weariness/tiredness/fatigue/feeling of weakness

Linked indication - Antipyretic/febrifuge/relieve mild fever/reduce body temperature/body cooling

Linked indication - Decrease/reduce/relieve disturbed/restless sleep

Linked indication - Decrease/reduce/relieve cough

Linked indication - Relieve runny/dripping nose

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

Linked indication - Antipyretic/febrifuge/relieve mild fever/reduce body temperature/body cooling

Linked indication - Relieve runny/dripping nose

Linked indication - Decongestant/relieve nasal congestion

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

Decrease/reduce/relieve the severity of symptoms of mild upper respiratory tract infections

Linked indication - Antipyretic/febrifuge/relieve mild fever/reduce body temperature/body cooling

Linked indication - Decrease/reduce/relieve cough

Linked indication - Relieve runny/dripping nose

Linked indication - Relieve weariness/tiredness/fatigue/feeling of weakness

Linked indication - Decrease/reduce/relieve disturbed/restless sleep

Relieve symptoms of sore throat/pharyngitis

Traditionally used in Western herbal medicine to decrease/reduce/relieve symptoms of mild tonsillitis

Indication Requirements

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

Product presentation must only refer to mild tonsillitis.

Label statement: Adults only, OR Not to be used in children under 2 years of age without medical advice (or words to that effect).

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

Respiratory tract infections must be qualified by 'mild'.

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

Product presentation must not imply or refer to chronic fatigue syndrome.

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

Public Summary

Page 1 of

Produced at 11.01.2021 at 09:39:47 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

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

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

Andrographis paniculata

33.93 mg

Echinacea purpurea root Extract dry concentrate

104.17 mg

Equivalent: Echinacea purpurea (Dry)

625 mg

forsythia suspensa fruit Extract dry concentrate

87.5 mg

Equivalent: forsythia suspensa (Dry)

525 mg

Isatis tinctoria root Extract dry concentrate

90 mg

Equivalent: Isatis tinctoria (Dry)

450 mg

Isatis tinctoria leaf Extract dry concentrate

90 mg

Equivalent: Isatis tinctoria (Dry)

450 mg

Lonicera japonica flower bud Extract dry concentrate

55 mg

Equivalent: Lonicera japonica (Dry)

550 mg

Magnolia liliflora flower bud Extract dry concentrate

58.33 mg

Equivalent: Magnolia liliflora (Dry)

350 mg

Platycodon grandiflorus root Extract dry concentrate

75 mg

Equivalent: Platycodon grandiflorus (Dry)

375 mg

Schizonepeta tenuifolia leaf Extract dry concentrate

60 mg

Equivalent: Schizonepeta tenuifolia (Dry)

300 mg

Other Ingredients (Excipients)

calcium carbonate

calcium hydrogen phosphate

Carnauba Wax

colloidal anhydrous silica

croscarmellose sodium

hypromellose

macrogol 400

magnesium stearate

maltodextrin

microcrystalline cellulose

© 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 11.01.2021 at 09:39:47 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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