Baby & Child Runny Nose

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

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Active ingredient:
Allium cepa,Anemone pulsatilla,betacarotene,calcium ascorbate dihydrate,cyanocobalamin,Euphrasia officinalis,ferrosoferric phosphate,potassium dichromate,potassium iodide,pyridoxal 5-phosphate monohydrate,sodium chloride
Available from:
Brauer Natural Medicine Pty Ltd
Authorization status:
Listed
Authorization number:
322616

Public Summary

Summary for ARTG Entry:

322616

Baby & Child Runny Nose

ARTG entry for

Medicine Listed

Sponsor

Brauer Natural Medicine Pty Ltd

Postal Address

PO Box 234,TANUNDA, SA, 5352

Australia

ARTG Start Date

3/09/2019

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. Baby & Child Runny Nose

Product Type

Single Medicine Product

Effective date

3/09/2019

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

Maintain/support energy production

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

Traditionally used in Homoeopathic medicine to relieve eye discomfort

Maintain/support healthy eye function

Maintain/support eye health

Traditionally used in Homoeopathic medicine to relieve itchy eyes

Traditionally used in Homoeopathic medicine to relieve eye soreness

Maintain/support healthy eyesight/vision

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve watery eyes/excessive lacrimation

Maintain/support body mucous membrane health

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

Maintain/support general health and wellbeing

Aids/assists teeth development

Maintain/support healthy teeth

Maintain/support connective tissue health

Aid/assist/helps connective tissue production/formation

Public Summary

Page 1 of

Produced at 29.09.2019 at 05:29:25 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

Maintain/support bone health

Aids/assists healthy bone development/growth/building

Aid/assist healthy red blood cell production

Maintain/support blood health

Helps maintain/support haemoglobin formation/synthesis

Maintain/support blood capillary health

Maintain/support blood vessel health

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

Maintain/support immune system health

Maintain/support healthy immune system function

Aid/assist/helps protein synthesis in the body

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

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

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

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve headache symptoms

Aid/assist/helps synthesis of neurotransmitters

Maintain/support nervous system health

Maintain/support nervous system function

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

Traditionally used in Homoeopathic medicine to decongestant/relieve nasal congestion

Traditionally used in Homoeopathic medicine to decrease/reduce excess mucous

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

Traditionally used in Homoeopathic medicine to decrease/reduce/relieve the severity of symptoms of mild upper respiratory tract infections

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

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

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

Traditionally used in Homoeopathic medicine to enhance/improve/promote/increase cough productivity

Traditionally used in Homoeopathic medicine to relieve runny/dripping nose

Traditionally used in Homoeopathic medicine to relieve hoarseness of voice

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

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

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

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

Maintain/support skin health

Maintain/support skin integrity/structure

Maintain/support wound healing

Indication Requirements

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

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

Product presentation must not imply or refer to circulatory disorders/diseases/conditions e.g. thrombosis.

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

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

Respiratory tract infections must be qualified by 'mild'.

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

Product presentation must only refer to mild bronchitis.

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

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 immunological diseases.

Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis,

osteoporosis.

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 weight loss, label statement: When used in conjunction with a program of reduced intake of dietary calories and increased

physical activity.

Standard Indications

Public Summary

Page 2 of

Produced at 29.09.2019 at 05:29:25 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

No Standard Indications included on Record

Specific Indications

Warnings

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

Allium cepa (Homeopathic)

5 microlitre/mL

Anemone pulsatilla (Homeopathic)

5 microlitre/mL

betacarotene

240 microgram/mL

calcium ascorbate dihydrate

4.87 mg/mL

cyanocobalamin

.06 microgram/mL

Euphrasia officinalis (Homeopathic)

5 microlitre/mL

ferrosoferric phosphate (Homeopathic)

5 microlitre/mL

potassium dichromate (Homeopathic)

5 microlitre/mL

potassium iodide (Homeopathic)

5 microlitre/mL

pyridoxal 5-phosphate monohydrate

70.63 microgram/mL

sodium chloride (Homeopathic)

5 microlitre/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 29.09.2019 at 05:29:25 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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