Rest, Restore + Immunity

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

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Active ingredient:
Allium sativum,Armoracia rusticana,Echinacea purpurea,Glycyrrhiza glabra,Salix alba,Valeriana officinalis,zinc gluconate
Available from:
Global Health Initiative
Authorization status:
Listed
Authorization number:
352560

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Public Summary

Summary for ARTG Entry:

352560

Rest, Restore + Immunity

ARTG entry for

Medicine Listed

Sponsor

Global Health Initiative

Postal Address

16/73 Evans Street, Freshwater, NSW, 2096

Australia

ARTG Start Date

6/01/2021

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 . Rest, Restore + Immunity

Product Type

Single Medicine Product

Effective Date

6/01/2021

Permitted Indications

Maintain/support immune system health

Maintain/support healthy immune system function

Traditionally used in Western herbal medicine to soporific/induces sleep

Traditionally used in Western herbal medicine to maintains/supports refreshing sleep

Traditionally used in Western herbal medicine to decrease/reduce/relieve disturbed/restless sleep

Traditionally used in Western herbal medicine to enhance/improve/promote/increase sleep quality/deep sleep

Traditionally used in Western herbal medicine to decrease/reduce/relieve the severity of common cold symptoms

Traditionally used in Western herbal medicine to relieve symptoms of mild upper respiratory tract infections

Indication Requirements

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

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

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 immunological diseases.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

No Warnings included on Record

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

Public Summary

Page 1 of

Produced at 11.01.2021 at 07:27:52 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

1 . Formulation 1

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

Allium sativum bulb Extract dry concentrate

5 mg

Equivalent: Allium sativum (Fresh)

500 mg

Armoracia rusticana root Extract dry concentrate

200 mg

Equivalent: Armoracia rusticana (Dry)

Echinacea purpurea herb top Juice concentrate

44.4 mg

Equivalent: Echinacea purpurea (Juice fresh)

Glycyrrhiza glabra root and stolon Extract dry concentrate

100 mg

Equivalent: Glycyrrhiza glabra (Dry)

500 mg

Salix alba stem bark Extract dry concentrate standardised

40 mg

Equivalent: Salicin ()

4 mg

Equivalent: Salix alba (Dry)

1000 mg

Valeriana officinalis root Extract dry concentrate

333.34 mg

Equivalent: Valeriana officinalis (Dry)

zinc gluconate

93.6 mg

Equivalent: zinc

12 mg

Other Ingredients (Excipients)

allura red AC

calcium hydrogen phosphate

Carnauba Wax

colloidal anhydrous silica

croscarmellose sodium

hypromellose

indigo carmine

macrogol 3350

macrogol 400

magnesium stearate

maltodextrin

microcrystalline cellulose

polyvinyl alcohol

povidone

purified talc

sunset yellow FCF

titanium dioxide

© 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 07:27:53 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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