Men's 50+ Multi

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

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Active ingredient:
Apium graveolens,Arthrospira platensis,Ascophyllum nodosum,betacarotene,borax,Beta vulgaris,Brassica oleracea var. botrytis,Brassica oleracea var. capitata,Brassica oleracea var. italica,Brassica oleracea var. viridis,calcified lithothamnion species,calcium ascorbate,calcium pantothenate,chromium picolinate,colecalciferol,cupric sulfate,curcumin,Camellia sinensis,Capsicum annuum,Chlorella vulgaris,Citrus sinensis,Coriandrum sativum,Cynara scolymus,d-alpha-tocopherol,Echinacea purpurea,Eruca
Available from:
Factors Group Australia Pty Ltd
Authorization status:
Listed
Authorization number:
323097

Public Summary

Summary for ARTG Entry:

323097

Men's 50+ Multi

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. Men's 50+ Multi

Product Type

Single Medicine Product

Effective date

12/09/2019

Permitted Indications

Antioxidant/Reduce free radicals formed in the body

Maintain/support healthy eye function

Maintain/support eye health

Maintain/support healthy eyesight/vision

Maintain/support general health and wellbeing

Maintain/support hair health

Maintain/support nail health/strength/thickness

Maintain/support bone health

Vitamin D helps calcium absorption (or words of like intent) and a diet deficient in calcium can lead to osteoporosis in later life

Maintain/support cardiovascular system health

Maintain/support healthy cardiovascular system function

Maintain/support immune system health

Maintain/support healthy immune system function

Maintain/support muscle health

Aid/assist/helps glucose/sugar/carbohydrate metabolism

Maintain/support (state vitamin/mineral/nutrient) levels in the body

Helps prevent dietary (state vitamin/mineral/nutrient) deficiency

Maintain/support (state vitamin/mineral) within normal range

Maintain/support cognitive function/mental function

Maintain/support memory/mental recall

Public Summary

Page 1 of

Produced at 29.09.2019 at 04:52:34 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

Maintain/support brain health

Maintain/support skin health

Indication Requirements

Product presentation must not imply or refer to vision correction, faults or serious eye disease e.g. macular degeneration.

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.

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

Product presentation must not imply or refer to lowering or raising blood sugar/glucose levels from outside of the normal healthy range.

Product presentation must not imply or refer to serious cardiovascular conditions.

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

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis,

osteoporosis.

If product is indicated for supplementation, 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

Indication only for use for medicines that contain vitamin D as an active ingredient. The medicines may only contain a maximum recommended daily dose

of 25 micrograms or less of vitamin D and as a min

Standard Indications

No Standard Indications included on Record

Specific Indications

Warnings

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.

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

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

Apium graveolens

200 microgram

Equivalent: Apium graveolens (Fresh)

3 mg

Apium graveolens

2.25 mg

Equivalent: Apium graveolens (Dry)

22.5 mg

Arthrospira platensis

5 mg

Ascophyllum nodosum

18.75 mg

betacarotene

3 mg

Beta vulgaris

178 microgram

Equivalent: Beta vulgaris (Fresh)

1.78 mg

Beta vulgaris

2.25 mg

borax

6.579 mg

Brassica oleracea var. botrytis

3.75 mg

Brassica oleracea var. botrytis

181 microgram

Equivalent: Brassica oleracea var. botrytis (Fresh)

2.715 mg

Brassica oleracea var. capitata

368 microgram

Equivalent: Brassica oleracea var. capitata (Fresh)

16.56 mg

Brassica oleracea var. capitata

3.75 mg

Brassica oleracea var. italica

3.75 mg

Brassica oleracea var. viridis

2.25 mg

Brassica oleracea var. viridis

33 microgram

Public Summary

Page 2 of

Produced at 29.09.2019 at 04:52:34 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

Equivalent: Brassica oleracea var. viridis (Fresh)

132 microgram

calcified lithothamnion species

28.722 mg

calcium ascorbate

38.584 mg

calcium pantothenate

5.458 mg

Camellia sinensis

5 mg

Equivalent: Camellia sinensis (Dry)

150 mg

Capsicum annuum

260 microgram

Equivalent: Capsicum annuum (Fresh)

5.2 mg

Chlorella vulgaris

5 mg

chromium picolinate

201.1263 microgram

Citrus sinensis

5 mg

Equivalent: Citrus sinensis (Dry)

1.75 g

colecalciferol

.0125 mg

Coriandrum sativum

16 microgram

Equivalent: Coriandrum sativum (Fresh)

16 microgram

Coriandrum sativum

2.25 mg

cupric sulfate

2 mg

curcumin

.5 mg

Cynara scolymus

1 microgram

Equivalent: Cynara scolymus (Fresh)

149.9 ng

Cynara scolymus

2.25 mg

d-alpha-tocopherol

10 mg

Echinacea purpurea

88 microgram

Equivalent: Echinacea purpurea (Fresh)

616 microgram

Eruca sativa

3.75 mg

Euterpe oleracea

5 mg

Fragaria vesca

250 microgram

Hordeum vulgare

2.25 mg

Laminaria digitata

5 mg

Laminaria japonica

360 microgram

levomefolate glucosamine

462.963 microgram

lutein

1 mg

lycopene

1 mg

Lycopersicon esculentum

2.25 mg

Lycopersicon esculentum

133 microgram

Equivalent: Lycopersicon esculentum (Fresh)

399 microgram

magnesium ascorbate

45.5 mg

magnesium aspartate

19.875 mg

magnesium citrate

24.537 mg

manganese gluconate

43.86 mg

mecobalamin (co-methylcobalamin)

200 microgram

Medicago sativa

1.713 mg

Equivalent: Medicago sativa (Fresh)

42.825 mg

menaquinone 7

40 microgram

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

9 microgram

Equivalent: Nasturtium officinale (Fresh)

7.2 microgram

Nasturtium officinale

2.5 mg

nicotinamide

12.5 mg

Origanum vulgare

39 microgram

Public Summary

Page 3 of

Produced at 29.09.2019 at 04:52:34 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

Equivalent: Origanum vulgare (Fresh)

156 microgram

Petroselinum crispum

771 microgram

Equivalent: Petroselinum crispum (Fresh)

15.42 mg

Petroselinum crispum

2.25 mg

Phyllanthus emblica

10 mg

Equivalent: Phyllanthus emblica (Dry)

500 mg

Phyllanthus emblica

65 mg

Equivalent: Phyllanthus emblica (Dry)

3.25 g

Punica granatum

250 microgram

pyridoxal 5-phosphate monohydrate

2.03 mg

Raphanus sativus

7.5 mg

Raphanus sativus

2.25 mg

riboflavin sodium phosphate

1.7093 mg

Rubus idaeus

250 microgram

Schisandra chinensis

5 mg

Equivalent: Schisandra chinensis (Dry)

100 mg

selenomethionine

124.18 microgram

Serenoa repens

25 mg

Equivalent: Serenoa repens (Fresh)

200 mg

Silybum marianum

5 mg

Equivalent: Silybum marianum (Dry)

125 mg

Taraxacum officinale

2.25 mg

thiamine hydrochloride

6.355 mg

Vaccinium macrocarpon

250 microgram

Vaccinium macrocarpon

5 mg

Vaccinium myrtillus

250 microgram

Vitis vinifera

2 mg

Equivalent: Vitis vinifera (Dry)

200 mg

Vitis vinifera

21.5 mg

Equivalent: Vitis vinifera (Dry)

795.5 mg

zinc citrate

36.6 mg

Zingiber officinale

5 mg

Equivalent: Zingiber officinale (Dry)

125 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 4 of

Produced at 29.09.2019 at 04:52:34 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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