Manuka Honey Chesty Cough

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

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Active ingredient:
antimony potassium tartrate trihydrate,Anemone pulsatilla,betacarotene,colecalciferol,Drosera rotundifolia MIS,Hedera helix,Honey,marine sponge,phosphorus,zinc glycinate
Available from:
Brauer Natural Medicine Pty Ltd
Authorization status:
Listed
Authorization number:
321824

Public Summary

Summary for ARTG Entry:

321824

Manuka Honey Chesty Cough

ARTG entry for

Medicine Listed

Sponsor

Brauer Natural Medicine Pty Ltd

Postal Address

PO Box 234,TANUNDA, SA, 5352

Australia

ARTG Start Date

15/08/2019

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. Manuka Honey Chesty Cough

Product Type

Single Medicine Product

Effective date

15/08/2019

Permitted Indications

Antioxidant/Reduce free radicals formed in the body in children

Helps reduce/decrease free radical damage to body cells in children

Traditionally used in Homoeopathic medicine to relieve feelings of general malaise/general debility in children

Traditionally used in Homoeopathic medicine to relieve weariness/tiredness/fatigue/feeling of weakness in children

Maintain/support healthy eye function in children

Maintain/support eye health in children

Maintain/support healthy eyesight/vision in children

Maintain/support healthy growth and development in children

Maintain/support body mucous membrane health in children

Maintain/support general health and wellbeing in children

Traditionally used in Western herbal medicine to maintain/support general health and wellbeing in children

Traditionally used in Homoeopathic medicine to maintain/support general health and wellbeing in children

Maintain/support general health and wellbeing when sun exposure is inadequate in children

Maintain/support hair health in children

Aids/assists teeth development in children

Maintain/support healthy teeth in children

Maintain/support teeth mineralisation in children

Maintain/support teeth strength in children

Maintain/support nail health/strength/thickness in children

Maintain/support bone health in children

Public Summary

Page 1 of

Produced at 29.08.2019 at 04:44:42 AEST

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

Aids/assists healthy bone development/growth/building in children

Maintain/support bone strength in children

Help maintain/support bone mineralisation in children

Maintain/support immune system health in children

Maintain/support healthy immune system function in children

Maintain/support muscle function in children

Maintain/support healthy neuromuscular system/function in children

Aid/assist/helps protein synthesis in the body in children

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

Maintain/support (state vitamin/mineral/nutrient) levels in the body in children

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

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

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve restlessness/excess nervous energy in children

Maintain/support cognitive function/mental function in healthy children

Maintain/support nerve conduction in children

Maintain/support nervous system function in children

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve sleeplessness in children

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve disturbed/restless sleep in children

Traditionally used in Homoeopathic medicine to decongestant/relieve nasal congestion in children

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve mild bronchial irritation in children

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve bronchial mucous congestion in children

Traditionally used in Western herbal medicine to decrease/reduce/relieve bronchial mucous congestion in children

Traditionally used in Homoeopathic medicine to soothe/calm the chest in children

Traditionally used in Western herbal medicine to decrease/reduce excess chest phlegm in children

Traditionally used in Homoeopathic medicine to decrease/reduce excess chest phlegm in children

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve symptoms of head cold in children

Traditionally used in Western herbal medicine to loosen chest phlegm in children

Traditionally used in Homoeopathic medicine to loosen chest phlegm in children

Traditionally used in Western herbal medicine to decrease/reduce excess mucous in children

Traditionally used in Homoeopathic medicine to decrease/reduce excess mucous in children

Traditionally used in Western herbal medicine to decrease/reduce/relieve mild upper respiratory tract congestion in children

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve mild upper respiratory tract congestion in children

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

Traditionally used in Homoeopathic medicine to expectorant/clear respiratory tract mucous in children

Traditionally used in Western herbal medicine to loosen respiratory tract mucous in children

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve sneezing in children

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve mild bronchial cough in children

Traditionally used in Western herbal medicine to decrease/reduce/relieve mild bronchial cough in children

Traditionally used in Western herbal medicine to decrease/reduce/relieve cough in children

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve cough in children

Traditionally used in Western herbal medicine to enhance/improve/promote/increase cough productivity in children

Traditionally used in Homoeopathic medicine to soothe respiratory tract mucous membranes/mucous tissue in children

Traditionally used in Homoeopathic medicine to relieve runny/dripping nose in children

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve throat irritation in children

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve symptoms of laryngitis in children

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve throat mucous membrane irritation/inflammation in children

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve throat mucous membrane irritation/inflammation in children

Traditionally used in Homoeopathic medicine to relieve symptoms of sore throat/pharyngitis in children

Maintain/support skin health in children

Maintain/support skin integrity/structure in children

Maintain/support skin regeneration in children

Maintain/support wound healing in children

Indication Requirements

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

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

Public Summary

Page 2 of

Produced at 29.08.2019 at 04:44:42 AEST

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 bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis,

osteoporosis.

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

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

Product presentation must only refer to mild bronchitis.

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

Product presentation must not imply or refer to serious musculoskeletal or neurological conditions.

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

Label statement: Adults only, OR Not to be used in children under 2 years of age without medical advice.

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 imply chronic fatigue syndrome.

Respiratory tract infections must be qualified by 'mild'.

Standard Indications

No Standard Indications included on Record

Specific Indications

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].

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

Not suitable for infants under the age of twelve months (or words to that effect).

Contains homoeopathic ingredients.

(If medicine contains one hydroxybenzoate) Contains [insert name of hydroxybenzoate] OR (If medicine contains two or more hydroxybenzoates)

Contains hydroxybenzoates [or words to that effect].

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

Anemone pulsatilla (Homeopathic)

5 microlitre/mL

antimony potassium tartrate trihydrate (Homeopathic)

5 microlitre/mL

betacarotene

.18 mg/mL

colecalciferol

.0002 mg/mL

Drosera rotundifolia MIS (Homeopathic)

5 microlitre/mL

Hedera helix

10.937 mg/mL

Equivalent: Hedera helix (Dry)

43.75 mg/mL

Honey

325 mg/mL

Honey

65 mg/mL

marine sponge (Homeopathic)

5 microlitre/mL

phosphorus (Homeopathic)

5 microlitre/mL

zinc glycinate

.71 mg/mL

© 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 29.08.2019 at 04:44:42 AEST

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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