Main information



  • Available in:
  • Loquat Leaf Cough Mixture with Cordyceps
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222070
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Loquat Leaf Cough Mixture with Cordyceps

ARTG entry for

Medicine Listed


Well Herb Pty Ltd

Postal Address

PO Box 781,CABRAMATTA, NSW, 2166


ARTG Start Date


Product category




Approval area

Listed Medicines


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


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.


1. Loquat Leaf Cough Mixture with Cordyceps

Product Type

Single Medicine Product

Effective date



If coughing persists consult your doctor (or a healthcare professional) (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).

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

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

Standard Indications

Temporary relief of cough due to bronchial congestion. [Warnings COU1 and COU2 required]

Relief of coughs. [Warnings COU1 and COU2 required]

Temporary relief of cough due to bronchial irritation. [Warnings COU1 and COU2 required]

Temporary relief of bronchial cough by soothing bronchial airways. [Warnings COU1 and COU2 required]

Specific Indications

To relieve dry and sore throat as well as remove heat.

A Traditional Chinese Medicine.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule


1. Formulation 1

Public Summary

Page 1 of

Produced at 26.11.2017 at 12:12:25 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

Dosage Form

Oral Liquid

Route of Administration


Visual Identification

Active Ingredients

Citrus reticulata

24.275 microlitre/mL

Equivalent: Citrus reticulata (Dry)

1.6 mg/mL

Cordyceps sinensis

6.069 microlitre/mL

Equivalent: Cordyceps sinensis (Dry)

.4 mg/mL

Eriobotrya japonica

101.197 microlitre/mL

Equivalent: Eriobotrya japonica (Dry)

6.67 mg/mL

Fritillaria cirrhosa

125.928 microlitre/mL

Equivalent: Fritillaria cirrhosa (Dry)

8.3 mg/mL

Glycyrrhiza uralensis

101.197 microlitre/mL

Equivalent: Glycyrrhiza uralensis (Dry)

6.67 mg/mL

Mentha haplocalyx

75.86 microlitre/mL

Equivalent: Mentha haplocalyx (Dry)

5 mg/mL

Pinellia ternata

50.068 microlitre/mL

Equivalent: Pinellia ternata (Dry)

3.33 mg/mL

Platycodon grandiflorus

75.86 microlitre/mL

Equivalent: Platycodon grandiflorus (Dry)

5 mg/mL

Polygala sibirica

50.068 microlitre/mL

Equivalent: Polygala sibirica (Dry)

3.3 mg/mL

Siraitia grosvenorii

125.928 microlitre/mL

Equivalent: Siraitia grosvenorii (Dry)

8.3 mg/mL

Stemona sessilifolia

75.86 microlitre/mL

Equivalent: Stemona sessilifolia (Dry)

5 mg/mL

Zingiber officinale

101.197 microlitre/mL

Equivalent: Zingiber officinale (Dry)

6.67 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 2 of

Produced at 26.11.2017 at 12:12:25 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