Muscle

Main information

Documents

Localization

  • Available in:
  • Muscle and Cramp Relief
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221462
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221462

Muscle and Cramp Relief

ARTG entry for

Medicine Listed

Sponsor

Australia Cobayer Health Food Co Pty Ltd

Postal Address

Unit 8 / 18 College Street,DARLINGHURST, NSW, 2010

Australia

ARTG Start Date

19/03/2014

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. Muscle and Cramp Relief

Product Type

Single Medicine Product

Effective date

19/03/2014

Warnings

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

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

Standard Indications

Specific Indications

INDICATIONS A

* SUPMIN ± For Magnesium supplementation

* WELL ± Aids, assists of helps in the maintenance or improvement of general wellbeing.

INDICATIONS B

* Magnesium plays a necessary role in over 300 enzymatic reactions in the body.

INDICATIONS C

* Magnesium plays a critical role in energy production in the body.

* Magnesium is involved in the production of ATP.

* Magnesium is required for the production of cellular energy.

INDICATIONS D

* Magnesium plays an important role in cellular activity.

INDICATIONS E

* Magnesium plays a vital role in the metabolism of carbohydrates in the body.

* Contains nutrients essential for carbohydrate, protein and fat metabolism.

* Supports healthy metabolism of proteins, carbohydrates and fats in the body.

INDICATIONS F

* Magnesium plays a vital role in calcium metabolism.

INDICATIONS G

* Magnesium plays a vital role in the body in neuromuscular transmission.

* Magnesium is necessary for proper muscle and nerve function.

* Magnesium helps to maintain normal healthy functioning of the nervous system.

* Contains nutrients essential for healthy nervous system function.

* Supports the health and function of the nervous system.

* Contains nutrients required in the body for nerve cell function and muscle action.

INDICATIONS H

* Supports/maintains the health and function of the cardiovascular system/heart.

* CHOL01 ± May assist in the maintenance of cholesterol within the normal range in healthy individuals

Public Summary

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Visit www.tga.gov.au for contact information

* CHOL02 ± May assist in the maintenance of normal/healthy cholesterol levels in healthy individuals

* CHOL03 ± May assist in the maintenance of cholesterol within the normal/healthy range in healthy individuals and improve HDL:LDL ratio.

* CHOL04 - May assist in the maintenance of normal/healthy HDL:LDL cholesterol ratio.

* CHOL06 ± May help to reduce the oxidation of LDL cholesterol.

INDICATIONS I

* MENS9 - May assist in the management of pre-menstrual tension/syndrome

* PMS ± Relief of pre-menstrual symptoms/syndrome

INDICATIONS J

* Magnesium is an essential constituent of the bones and it supports the health and strength of the bones.

* Magnesium assists in maintaining healthy bone mineral density.

* Adequate magnesium is important for healthy bones.

* Supports healthy bone growth.

* Supports bone health.

* Supports healthy bone mineral density

INDICATIONS K

* MUSC1 ± Relief of muscular aches and pains.

* MUSC2 ± Relief of muscular cramps and spasms.

INDICATIONS L

* Supports healthy immune system function.

* Supports the health and function of the immune system.

* Contains nutrients that play important roles in the proper functioning of the immune system.

INDICATIONS M

* Supports healthy brain function.

* Contains nutrients necessary for healthy brain function

INDICATIONS N

* BLOOD2 - Helps maintain normal blood/blood tonic.

INDICATIONS O

* Supports healthy skin, hair and nails.

* Contains nutrients that support the health of the skin and are involved in wound healing.

INDICATIONS P

* Vitamin B6 (Pyridoxine) interacts with magnesium and helps to increase the body's accumulation of magnesium.

INDICATIONS Q

* Contains easily absorbable forms of magnesium.

* More soluble forms of magnesium increase absorption. INDICATIONS R

* BLDGL01 - May assist in the maintenance of normal healthy blood sugar/glucose levels in healthy individuals.

* BLDGL02 - May assist in the maintenance of normal healthy glycaemic controls in healthy individuals.

* BLDGL03 - May assist in the maintenance of normal healthy blood sugar/glucose balance in healthy individuals.

INDICATIONS S

· Contains pantothenic acid, which is required for proper function of the adrenal gland.

· Pantothenic acid supports the adrenal glands in the making of cortisone and other adrenal hormones that counteract the stress response

· NERV2 ± Beneficial during times of stress

INDICATIONS T

· Contains nutrients that are involved in hormone synthesis and modulation.

INDICATIONS U

· Contains pantothenic acid, which is required for proper function of the adrenal gland.

· Pantothenic acid supports the adrenal glands in the making of cortisone and other adrenal hormones that counteract the stress response

· NERV2 ± Beneficial during times of stress.

* The human body has increased requirements for the vitamins (especially the B group) and minerals during periods of stress

* During stress, nutrients such as vitamin C, Vitamin B6 and vitamin B5 are important for supporting adrenal function.

* Vitamin B5 has long been considered the "anti-stress" vitamin because of its central role in adrenal function and cellular metabolism.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Oral Liquid, powder for

Route of Administration

Oral

Visual Identification

Active Ingredients

Ascorbic acid

24 mg/g

Calcium pantothenate

15.28 mg/g

Cyanocobalamin

4 microgram/g

Folic acid

30 microgram/g

Glutamine

100 mg/g

levocarnitine tartrate

14.66 mg/g

Magnesium amino acid chelate

75 mg/g

Magnesium aspartate dihydrate

133.33 mg/g

Magnesium citrate

61.88 mg/g

magnesium phosphate tribasic

169.41 mg/g

monobasic potassium phosphate

69.61 mg/g

Nicotinamide

4 mg/g

Public Summary

Page 2 of

Produced at 26.11.2017 at 12:54:12 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

pyridoxine hydrochloride

10 mg/g

Riboflavin

400 microgram/g

Taurine

100 mg/g

Thiamine hydrochloride

5.61 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 3 of

Produced at 26.11.2017 at 12:54:12 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