Main information



  • Available in:
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216265
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:



ARTG entry for

Medicine Listed


Phytologic Holdings Pty Ltd

Postal Address

PO Box 6193,Alexandria, NSW, 2015


ARTG Start Date


Product category




Approval area

Listed Medicines


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


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.



Product Type

Single Medicine Product

Effective date



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).

Standard Indications

Relief of muscular aches and pains. [Warning S required]

Aids, assists or helps in the maintenance of general well-being

Aids or assists in the prevention of muscular cramps and spasms.

Relief of muscular cramps and spasms. [Warning S required]

For mineral (may state the mineral) supplementation.

Specific Indications

[1] Contains magnesium, which helps the body metabolise carbohydrates and fats/Contains magnesium, which is involved in carbohydrate and lipid


[2] Contains magnesium, which is involved in Energy production/Contains magnesium, which is required for the production of energy in the body

[3] Contains magnesium, which plays a necessary role in over 300 enzymatic reactions in the body/Magnesium is involved in over 300 essential

metabolic reactions.

[4] Contains Magnesium, which plays a vital role in the body in neuromuscular transmission/Contains Magnesium, which is necessary for proper muscle

and nerve function/ Contains Magnesium, which helps to maintain normal healthy functioning of the nervous system.

[5] Contains magnesium, which helps in the development of healthy bones and teeth/Contains magnesium, which is important for normal bone structure.

[6] Contains magnesium, which supports normal/healthy cardiovascular function

[7] Contains magnesium, which is involved in protein synthesis/ Contains magnesium, which is involved in amino acid activation.

[8] Contains magnesium, which is required for the synthesis of the antioxidant glutathione.

[9] Supplies important cofactors to support the actions of magnesium, including taurine, glutamine, carnitine and vitamin c.

[10] Helps relieve muscular aches, pains, cramps and spasms /Contains magnesium which may assist with the relief of muscle cramps

[11] May provide symptomatic relief of pre-menstrual syndrome including mood swings and bloating.

[12] May help reduce the frequency and severity of migraines.

[13] Contains Magnesium which is important for a healthy nervous system and may be beneficial during times of stress.

[14] Glutamine Supports normal healthy tissue and muscle repair /Glutamine helps repair and build muscle.

[15] Glutamine may assist in sparing muscle glutamine stores/Helps reduce muscle catabolism.

[16] Glutamine supports healthy immune function/ May help reduce exercise-induced immune impairment.

Public Summary

Page 1 of

Produced at 26.11.2017 at 07:30:33 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.

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[17] Glutamine is important for the regulation of acid-base balance

[18] Glutamine is involved in protein synthesis, energy production and, when necessary, glycogen production.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule


1. Formulation 1

Dosage Form

Powder, oral

Route of Administration


Visual Identification

Active Ingredients

calcium ascorbate dihydrate

48.7 mg/g


100 mg/g

Magnesium amino acid chelate

343 mg/g

magnesium glycinate dihydrate

85.47 mg/g

Magnesium orotate dihydrate

21.2 mg/g

Potassium aspartate

77.3 mg/g


200 mg/g

© 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

Public Summary

Page 2 of

Produced at 26.11.2017 at 07:30:33 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 for contact information