Caruso's Children's Brain Health

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

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Active ingredient:
concentrated fish Omega-3 triglycerides,potassium iodide,soy phosphatidylserine-enriched soy lecithin powder
Available from:
Caruso's Natural Health Pty Ltd
Authorization status:
Listed
Authorization number:
345958

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Public Summary

Summary for ARTG Entry:

345958

Caruso's Children's Brain Health

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

15/10/2020

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 Brain Health

Product Type

Single Medicine Product

Effective Date

21/10/2020

Permitted Indications

Helps maintain/support healthy eye development

Maintain/support healthy eye function

Maintain/support eye health

Maintain/support eye health

Maintain/support healthy eyesight/vision

Maintain/support healthy growth and development

Maintain/support healthy thyroid hormones

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

Helps enhance/improve/promote/increase attention span

Maintain/support cognitive development

Maintain/support mental concentration/focus/clarity

Enhance/improve/promote/increase cognitive performance

Maintain/support cognitive function/mental function

Maintain/support learning and information processing

Maintain/support brain function

Maintain/support brain health

Maintain/support nervous system health

Maintain/support brain/central nervous system development

Maintain/support nervous system function

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 mental illnesses, disorders or conditions.

Product presentation must not imply or refer to neurological conditions or developmental delays.

Product presentation must not imply or refer to any thyroid related diseases.

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.

Public Summary

Page 1 of

Produced at 12.01.2021 at 12:49:18 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

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).

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.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Active Ingredients

concentrated fish Omega-3 triglycerides

400 mg

Equivalent: eicosapentaenoic acid

40 mg

Equivalent: docosahexaenoic acid

200 mg

potassium iodide

52.3 microgram

Equivalent: potassium

12.3 microgram

Equivalent: iodine

40 microgram

soy phosphatidylserine-enriched soy lecithin powder

75 mg

Equivalent: soy phosphatidylserine

45 mg

Other Ingredients (Excipients)

citric acid

Flavour

Gelatin

glycerol

iron oxide red

iron oxide yellow

lecithin

medium chain triglycerides

purified water

Steviol glycosides

tapioca starch

xylitol

yellow beeswax

© 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 12.01.2021 at 12:49:18 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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