Respiratory Relief

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

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Active ingredient:
ascorbic acid,Allium sativum,Althaea officinalis,Apium graveolens,Armoracia rusticana,Arthrospira platensis,betacarotene,Beta vulgaris,Brassica oleracea var. botrytis,Brassica oleracea var. capitata,Brassica oleracea var. italica,Brassica oleracea var. viridis,curcumin,Camellia sinensis,Capsicum annuum,Chlorella vulgaris,Citrus sinensis,Coriandrum sativum,Cynara scolymus,Echinacea purpurea,Eruca sativa,Euterpe oleracea,Fragaria vesca,Hordeum vulgare,lutein,lycopene,Laminaria digitata,Laminaria
Available from:
Factors Group Australia Pty Ltd
Authorization status:
Listed
Authorization number:
323102

Public Summary

Summary for ARTG Entry:

323102

Respiratory Relief

ARTG entry for

Medicine Listed

Sponsor

Factors Group Australia Pty Ltd

Postal Address

Unit B 10-16 South Street,Rydalmere, NSW, 2116

Australia

ARTG Start Date

12/09/2019

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. Respiratory Relief

Product Type

Single Medicine Product

Effective date

12/09/2019

Permitted Indications

Decrease/reduce/relieve symptoms of hayfever

Decrease/reduce/relieve common cold duration

Decrease/reduce/relieve mild upper respiratory tract congestion

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

Decrease/reduce/relieve symptoms of sinusitis

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

Decrease/reduce/relieve symptoms of common cold

Indication Requirements

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 serious forms of respiratory disorders/diseases, such as: asthma, pneumonia, COAD, COPD, influenza.

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

Respiratory tract infections must be qualified by 'mild'.

Standard Indications

No Standard Indications included on Record

Specific Indications

Warnings

Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.

If symptoms persist consult your healthcare practitioner (or words to that effect).

Adults only (or words to that effect).

Public Summary

Page 1 of

Produced at 29.09.2019 at 04:51:38 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

This product contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not

be exceeded.

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

91 mg

Equivalent: Allium sativum (Fresh)

910 mg

Althaea officinalis

12.5 mg

Equivalent: Althaea officinalis (Dry)

50 mg

Apium graveolens

200 microgram

Equivalent: Apium graveolens (Fresh)

3 mg

Apium graveolens

100 microgram

Equivalent: Apium graveolens (Dry)

1 mg

Armoracia rusticana

187.5 mg

Equivalent: Armoracia rusticana (Dry)

1.5 g

Arthrospira platensis

636 microgram

ascorbic acid

500 mg

betacarotene

3.975 mg

Beta vulgaris

178 microgram

Equivalent: Beta vulgaris (Fresh)

1.78 mg

Beta vulgaris

100 microgram

Brassica oleracea var. botrytis

181 microgram

Equivalent: Brassica oleracea var. botrytis (Fresh)

2.715 mg

Brassica oleracea var. botrytis

150 microgram

Brassica oleracea var. capitata

368 microgram

Equivalent: Brassica oleracea var. capitata (Fresh)

16.56 mg

Brassica oleracea var. capitata

150 microgram

Brassica oleracea var. italica

150 microgram

Brassica oleracea var. viridis

100 microgram

Brassica oleracea var. viridis

33 microgram

Equivalent: Brassica oleracea var. viridis (Fresh)

132 microgram

Camellia sinensis

636 microgram

Equivalent: Camellia sinensis (Dry)

19.08 mg

Capsicum annuum

260 microgram

Equivalent: Capsicum annuum (Fresh)

5.2 mg

Chlorella vulgaris

636 microgram

Citrus sinensis

636 microgram

Equivalent: Citrus sinensis (Dry)

222.6 mg

Coriandrum sativum

100 microgram

Coriandrum sativum

16 microgram

Equivalent: Coriandrum sativum (Fresh)

16 microgram

curcumin

63.6 microgram

Cynara scolymus

100 microgram

Cynara scolymus

1 microgram

Equivalent: Cynara scolymus (Fresh)

149.9 ng

Public Summary

Page 2 of

Produced at 29.09.2019 at 04:51:38 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

Echinacea purpurea

225 mg

Equivalent: Echinacea purpurea (Fresh)

1.35 g

Echinacea purpurea

88 microgram

Equivalent: Echinacea purpurea (Fresh)

616 microgram

Eruca sativa

150 microgram

Euterpe oleracea

636 microgram

Fragaria vesca

10 microgram

Hordeum vulgare

100 microgram

Laminaria digitata

636 microgram

Laminaria japonica

360 microgram

lutein

1 mg

lycopene

1 mg

Lycopersicon esculentum

133 microgram

Equivalent: Lycopersicon esculentum (Fresh)

399 microgram

Lycopersicon esculentum

100 microgram

Medicago sativa

1.713 mg

Equivalent: Medicago sativa (Fresh)

42.825 mg

Mentha spicata

74 microgram

Equivalent: Mentha spicata (Fresh)

592 microgram

Mentha X piperita

206 microgram

Equivalent: Mentha X piperita (Fresh)

1.854 mg

Nasturtium officinale

150 microgram

Nasturtium officinale

9 microgram

Equivalent: Nasturtium officinale (Fresh)

7.2 microgram

Origanum vulgare

39 microgram

Equivalent: Origanum vulgare (Fresh)

156 microgram

Petroselinum crispum

771 microgram

Equivalent: Petroselinum crispum (Fresh)

15.42 mg

Petroselinum crispum

100 microgram

Phyllanthus emblica

10 mg

Equivalent: Phyllanthus emblica (Dry)

500 mg

Punica granatum

10 microgram

Raphanus sativus

300 microgram

Raphanus sativus

100 microgram

Rubus idaeus

10 microgram

Schisandra chinensis

636 microgram

Equivalent: Schisandra chinensis (Dry)

12.72 mg

Silybum marianum

250 microgram

Equivalent: Silybum marianum (Dry)

6.25 mg

Taraxacum officinale

100 microgram

Trigonella foenum-graecum

2 mg

Vaccinium macrocarpon

10 microgram

Vaccinium myrtillus

10 microgram

Vitis vinifera

860 microgram

Equivalent: Vitis vinifera (Dry)

31.82 mg

Vitis vinifera

80 microgram

Equivalent: Vitis vinifera (Dry)

8 mg

Zingiber officinale

636 microgram

Equivalent: Zingiber officinale (Dry)

15.9 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 3 of

Produced at 29.09.2019 at 04:51:38 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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