Turmeric & Magnesium

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

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Active ingredient:
Curcuma longa,heavy magnesium oxide,magnesium amino acid chelate,magnesium citrate,Piper nigrum
Available from:
Phytologic Holdings Pty Ltd
Authorization status:
Listed
Authorization number:
347720

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Public Summary

Summary for ARTG Entry:

347720

Turmeric & Magnesium

ARTG entry for

Medicine Listed

Sponsor

Phytologic Holdings Pty Ltd

Postal Address

PO Box 6193, Alexandria, NSW, 2015

Australia

ARTG Start Date

9/11/2020

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 . Turmeric & Magnesium

Product Type

Single Medicine Product

Effective Date

9/11/2020

Permitted Indications

Antioxidant/Reduce free radicals formed in the body

Helps reduce/decrease free radical damage to body cells

Maintain/support energy levels when dietary intake is inadequate

Maintain/support energy production

Maintain/support general health and wellbeing

Anti-inflammatory/relieve inflammation

Maintain/support bone health

Traditionally used in Ayurvedic medicine to decrease/reduce/relieve mild joint aches and pains

Maintain/support cardiovascular system health

Relieve digestive discomfort

Decrease/reduce/relieve muscle cramps when dietary intake is inadequate

Helps decrease/reduce/relieve mild muscle spasms/twitches when dietary intake is inadequate

Maintain/support muscle health

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

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

Aid/assist/helps metabolism of (state vitamin/mineral/nutrient)

Maintain/support nervous system health

Maintain/support nervous system function

Indication Requirements

Product presentation must only refer to mild joint symptoms.

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

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 balanced diet.

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

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

If product is indicated for weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased

Public Summary

Page 1 of

Produced at 11.01.2021 at 11:10:31 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

physical activity.

Product presentation must not imply or refer to serious musculoskeletal or neurological conditions.

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

Note: this requirement is not intended to apply where the indications referring to osteoporosis specified in column 2 of Table 2 of this instrument are also

used.

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 bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.

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

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

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

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

Curcuma longa rhizome Extract dry concentrate

75 mg

Equivalent: Curcuma longa (Dry)

1.5 g

heavy magnesium oxide

165.81 mg

Equivalent: magnesium

100 mg

magnesium amino acid chelate

200 mg

Equivalent: magnesium

40 mg

magnesium citrate

453.07 mg

Equivalent: magnesium

70 mg

Piper nigrum fruit Extract dry concentrate standardised

5.26 mg

Equivalent: Piper nigrum (Dry)

131.5 mg

Other Ingredients (Excipients)

colloidal anhydrous silica

hypromellose

magnesium stearate

maltodextrin

purified water

silicon dioxide

sorbitol

© 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 11:10:31 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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