Nature’s

Main information

Documents

Localization

  • Available in:
  • Nature’s Own High Potency Muscle Relief
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222002
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222002

Nature's Own High Potency Muscle Relief

ARTG entry for

Medicine Listed

Sponsor

Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare

Postal Address

PO Box 403,VIRGINIA, QLD, 4014

Australia

ARTG Start Date

4/04/2014

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. Nature's Own High Potency Muscle Relief

Product Type

Single Medicine Product

Effective date

4/04/2014

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.

Do not take while on warfarin therapy without medical advice.

(If medicine contains one sulfite) Contains [insert name of sulfite] OR (If medicine contains two or more sulfites) Contains sulfites [or words to that effect].

NB: Includes bisulfate and metabisulfite salts and sulfur dioxide.

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

Standard Indications

Specific Indications

Magnesium is important for muscle contraction and relaxation, and its supplementation at adequate level may help relieve muscle cramps, muscle

weakness and muscle spasms.

Adequate magnesium level helps maintain muscle health.

Adequate magnesium is important for muscle contraction and relaxation and its inadequacy may result muscle cramps, muscle weakness and muscle

spasms.

Magnesium may be beneficial for nocturnal leg cramps.

May help to provide relief of sleeplessness associated with restless legs.

Maintains the body's biochemical pathways for energy production.

Co-enzyme Q10 plays a vital role in energy production and is therefore important for all energy-dependent processes including heart muscle contraction.

Strengthens the body's antioxidant network.

Helps protect the body from oxidative stress resulting from free radical damage.

Magnesium may help to reduce the frequency and severity of menstrual migraines.

Magnesium is important for several biological processes such as cellular energy metabolism, cell replication, and protein synthesis.

Magnesium plays an essential role in a wide range of fundamental biologic reactions and is therefore an essential mineral for the body.

Magnesium plays important roles in the structure and the function of the human body.

Adequate magnesium level helps maintain normal muscle and nerve function.

Magnesium is an important nutrient for the cardiovascular system.

Adequate dietary magnesium is important for heart health / May help maintain heart health.

Adequate intake of magnesium is required for cardiovascular health / May help maintain cardiovascular health.

Additional Product information

Public Summary

Page 1 of

Produced at 26.11.2017 at 12:15:29 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

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Powder

Route of Administration

Oral

Visual Identification

Active Ingredients

Ascorbic acid

20 mg/g

calcium hydrogen phosphate dihydrate

42.918 mg/g

Calcium pantothenate

7 mg/g

Chromium picolinate

20.3 microgram/g

Cyanocobalamin

2.5 microgram/g

Folic acid

15 microgram/g

Glutamine

50 mg/g

Magnesium citrate nonahydrate

304.348 mg/g

Manganese gluconate

1.75 mg/g

Nicotinamide

2.5 mg/g

Potassium citrate

20.743 mg/g

pyridoxine hydrochloride

2.5 mg/g

riboflavine

1 mg/g

Selenomethionine

6.25 microgram/g

Taurine

50 mg/g

Thiamine nitrate

2.5 mg/g

Ubidecarenone

5 mg/g

Zinc gluconate

3.808 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 http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 26.11.2017 at 12:15:29 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