Kids Cold & Flu Liquid

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

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Active ingredient:
bovine lactoferrin,ferric pyrophosphate,Sambucus nigra
Available from:
Biomonia Pty Ltd
Authorization status:
Listed
Authorization number:
349002

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Public Summary

Summary for ARTG Entry:

349002

Kids Cold & Flu Liquid

ARTG entry for

Medicine Listed

Sponsor

Biomonia Pty Ltd

Postal Address

17 Mount Street, Glen Waverley, VIC, 3150

Australia

ARTG Start Date

19/11/2020

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 . Kids Cold & Flu Liquid

Product Type

Single Medicine Product

Effective Date

19/11/2020

Permitted Indications

Relieve weariness/tiredness/fatigue/feeling of weakness when dietary intake is inadequate

Maintain/support healthy growth and development when dietary intake is inadequate in children

Aid/assist healthy red blood cell production

Maintain/support red blood cell health

Aid/assist/helps oxygen transport to body tissues

Maintain/support immune system health

Helps enhance/improve/promote immune system function

Maintain/support immune system to fight illness

Maintain/support cognitive development when dietary intake is inadequate in children

Maintain/support cognitive function/mental function

Traditionally used in Western herbal medicine to decongestant/relieve nasal congestion

Decrease/reduce/relieve common cold duration

Traditionally used in Western herbal medicine to decrease/reduce/relieve symptoms of common colds and flu

Linked indication - Sudorific/diaphoretic/enhance/promote sweating/perspiration

Traditionally used in Western herbal medicine to expectorant/clear respiratory tract mucous

Traditionally used in Western herbal medicine to relieve runny/dripping nose

Traditionally used in Western herbal medicine to decrease/reduce/relieve throat mucous membrane irritation/inflammation

Indication Requirements

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

Product presentation must not imply or refer to serious cardiovascular conditions.

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

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

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

Product presentation must not imply or refer to heart disease.

Product presentation must not imply or refer to mental illnesses, disorders or conditions.

Label statement: Adults only, OR Not to be used in children under 2 years of age without medical advice (or words to that effect).

Public Summary

Page 1 of

Produced at 11.01.2021 at 10:41:03 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

Product presentation must not imply or refer to serious forms of respiratory disorders/diseases, such as: asthma, pneumonia, COAD, COPD, influenza.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

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

(If medicine contains one benzoate) Contains [insert name of benzoate] Or (If medicine contains two or more benzoates) Contains benzoates [or words to

that effect].

(If the medicine contains one sorbate) Contains [insert name of sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to that

effect].

Not for the treatment of iron deficiency conditions (or words to that effect).

Adults only. OR Not to be used in children under two years of age without medical advice (or words to that effect).

Derived from cow's milk.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Oral Liquid

Route of Administration

Oral

Visual Identification

Active Ingredients

bovine lactoferrin

3 mg/mL

ferric pyrophosphate

1.04 mg/mL

Equivalent: iron

250 microgram/mL

Sambucus nigra fruit Extract dry concentrate

41.67 mg/mL

Equivalent: Sambucus nigra (Dry)

500 mg/mL

Other Ingredients (Excipients)

citric acid

Flavour

glycerol

liquid glucose

potassium sorbate

purified water

sodium benzoate

sucralose

xanthan gum

© 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 11.01.2021 at 10:41:03 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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