Caruso's Children's Multivitamin

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

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Active ingredient:
ascorbic acid,betacarotene,Biotin,calcium citrate tetrahydrate,calcium pantothenate,colecalciferol,cyanocobalamin,d-alpha-tocopheryl acid succinate,ferrous fumarate,folic acid,magnesium phosphate pentahydrate,manganese sulfate monohydrate,nicotinamide,potassium iodide,pyridoxine hydrochloride,riboflavin,selenomethionine,silicon dioxide,thiamine hydrochloride,zinc citrate dihydrate
Available from:
Caruso's Natural Health Pty Ltd
Authorization status:
Listed
Authorization number:
346424

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Public Summary

Summary for ARTG Entry:

346424

Caruso's Children's Multivitamin

ARTG entry for

Medicine Listed

Sponsor

Caruso's Natural Health Pty Ltd

Postal Address

PO Box 310, HORSLEY PARK, NSW, 2175

Australia

ARTG Start Date

22/10/2020

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 . Caruso's Children's Multivitamin

Product Type

Single Medicine Product

Effective Date

22/10/2020

Permitted Indications

Antioxidant/Reduce free radicals formed in the body

Helps reduce/decrease free radical damage to body cells

Maintain/support collagen formation

Maintain/support energy levels

Helps convert (state food) into energy

Maintain/support energy production

Maintain/support eye health

Aids/assists eye adaption to variations in light intensity/night vision

Maintain/support healthy eyesight/vision

Maintain/support body electrolyte balance

Maintain/support healthy growth and development

Maintain/support body mucous membrane health

Maintain/support general health and wellbeing

Maintain/support hair health

Aids/assists gum development

Maintain/support gum health

Aids/assists teeth development

Maintain/support healthy teeth

Maintain/support nail health/strength/thickness

Maintain/support connective tissue health

Aid/assist/helps connective tissue production/formation

Maintain/support bone health

Aids/assists healthy bone development/growth/building

Aid/assist healthy red blood cell production

Maintain/support red blood cell health

Maintain/support blood health

Helps maintain/support haemoglobin formation/synthesis

Public Summary

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Visit www.tga.gov.au for contact information

Maintain/support immune system health

Maintain/support healthy immune system function

Maintain/support immune system to fight illness

Helps stimulate a healthy immune system response

Maintain/support muscle function

Aid/assist/helps glucose/sugar/carbohydrate metabolism

Maintain/support absorption of dietary (state vitamin/mineral/nutrient)

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

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

Aids/assists the body to cope with environmental stress

Support healthy stress response in the body

Maintain/support brain function

Maintain/support brain health

Maintain/support nerve conduction

Aid/assist/helps synthesis of neurotransmitters

Maintain/support nervous system health

Maintain/support nervous system function

Maintain/support skin health

Maintain/support wound healing

Maintain/support skin repair/healing/regeneration

Indication Requirements

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

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.

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 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

physical activity.

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

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

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

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

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.

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

This medicine 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.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Tablet, chewable

Public Summary

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Produced at 12.01.2021 at 12:20:24 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

Route of Administration

Oral

Visual Identification

Active Ingredients

ascorbic acid

30 mg

betacarotene

180 microgram

Biotin

30 microgram

calcium citrate tetrahydrate

94.9 mg

Equivalent: calcium

20 mg

calcium pantothenate

2.17 mg

Equivalent: pantothenic acid

2 mg

Equivalent: calcium

180 microgram

colecalciferol

5 microgram

cyanocobalamin

5 microgram

d-alpha-tocopheryl acid succinate

12.5 mg

ferrous fumarate

9.13 mg

Equivalent: iron

3 mg

folic acid

300 microgram

magnesium phosphate pentahydrate

96.81 mg

Equivalent: magnesium

20 mg

manganese sulfate monohydrate

1.54 mg

Equivalent: manganese

500 microgram

nicotinamide

900 microgram

potassium iodide

98.1 microgram

Equivalent: potassium

23.1 microgram

Equivalent: iodine

75 microgram

pyridoxine hydrochloride

1.1 mg

Equivalent: pyridoxine

900 microgram

riboflavin

900 microgram

selenomethionine

37.3 microgram

Equivalent: selenium

15 microgram

silicon dioxide

21.4 mg

Equivalent: silicon

10 mg

thiamine hydrochloride

1.14 mg

Equivalent: thiamine

900 microgram

zinc citrate dihydrate

6.22 mg

Equivalent: zinc

2 mg

Other Ingredients (Excipients)

ascorbyl palmitate

dl-alpha-tocopherol

Flavour

hypromellose

magnesium stearate

modified food starch

silicon dioxide

sorbitol

Steviol glycosides

Sunflower Oil

Public Summary

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Produced at 12.01.2021 at 12:20:24 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

© 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 12.01.2021 at 12:20:24 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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