Qu Shi Pai Du Granules for Heat Body Constitution Dietary Edition

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

Buy It Now

Active ingredient:
Agastache rugosa,Allium cepa,Angelica dahurica,Coix lachryma-jobi,Dolichos lablab,Elsholtzia splendens,Gardenia jasminoides,Glycine max,Glycyrrhiza uralensis,Houttuynia cordata,Imperata cylindrica,Lonicera japonica,Lophatherum gracile,Nelumbo nucifera,Phragmites australis,Platycodon grandiflorus,Prunus persica,Siraitia grosvenorii,Zingiber officinale
Available from:
Australia Shineway Technology Pty Ltd
Authorization status:
Listed
Authorization number:
346482

Read the complete document

Public Summary

Summary for ARTG Entry:

346482

Qu Shi Pai Du Granules for Heat Body Constitution Dietary Edition

ARTG entry for

Medicine Listed

Sponsor

Australia Shineway Technology Pty Ltd

Postal Address

516/401 Sussex Street, Haymarket, NSW, 2000

Australia

ARTG Start Date

23/10/2020

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 . Qu Shi Pai Du Granules for Heat Body Constitution Dietary Edition

Product Type

Single Medicine Product

Effective Date

23/10/2020

Permitted Indications

Traditionally used in Chinese medicine to resolve dampness-phlegm in/of Damp-Heat pattern

Traditionally used in Chinese medicine to remove Heat toxin

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

Traditionally used in Chinese medicine to relieve dry mouth

Traditionally used in Chinese medicine to antipyretic/febrifuge/relieve mild fever/reduce body temperature/body cooling

Traditionally used in Chinese medicine to orexigenic/improve/promote healthy appetite

Traditionally used in Chinese medicine to decrease/reduce/relieve constipation

Traditionally used in Chinese medicine to decrease/reduce/relieve abdominal bloating/distention

Traditionally used in Chinese medicine to enhance/improve/promote immune defence/immunity

Traditionally used in Chinese medicine to decrease/reduce/relieve muscle pain/ache/soreness

Traditionally used in Chinese medicine to decrease/reduce/relieve symptoms of mild anxiety

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

Traditionally used in Chinese medicine to decrease/reduce/relieve sleeplessness

Traditionally used in Chinese medicine to decongestant/relieve nasal congestion

Traditionally used in Chinese medicine to helps decrease/reduce/relieve the severity of symptoms of common colds and flu

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

Traditionally used in Chinese medicine to decrease/reduce/relieve thirstiness associated with common cold

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

Traditionally used in Chinese medicine to relieve runny/dripping nose

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

Traditionally used in Chinese medicine to decrease/reduce/relieve symptoms of mild eczema/dermatitis

Traditionally used in Chinese medicine to relieve urinary frequency

Indication Requirements

If TCM terminology is used on medicine label, label statement: Talk to a TCM practitioner/health professional if you are unsure if this medicine is right for

you.

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

Public Summary

Page 1 of

Produced at 12.01.2021 at 12:17:06 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

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

Product presentation must only refer to detoxification in relation to natural body processes.

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

Label statement: Do not use when abdominal pain, nausea or vomiting are present or if you develop diarrhoea. If you are pregnant or breastfeeding - seek

the advice of a healthcare professional before taking this product (or words to that effect).

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

Product presentation must only refer to mild eczema.

Product presentation must not imply or refer to disease in any body organ, in particular the kidney or liver.

Product presentation must not imply or refer to gastro oesophageal reflux disease.

Label statement: Drink plenty of water (or words to that effect).

Product presentation must only refer to mild anxiety.

Label statement: Not to be used in children under 5 years.

Product presentation must not imply or refer to drugs/alcohol.

Label statement for stimulant laxatives: Prolonged use may cause serious bowel problems.

Product presentation must not refer to or imply weight loss.

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

Product presentation must not imply or refer to eating disorders.

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

Prolonged use may cause serious bowel problems.

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

Drink plenty of water (or words to that effect).

Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a

healthcare professional before taking this product (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).

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Granules

Route of Administration

Oral

Visual Identification

Active Ingredients

Agastache rugosa herb Extract dry concentrate

13.04 mg/g

Equivalent: Agastache rugosa (Dry)

260.87 mg/g

Allium cepa bulb Extract dry concentrate

30.43 mg/g

Equivalent: Allium cepa (Dry)

380.43 mg/g

Angelica dahurica root Extract dry concentrate

65.22 mg/g

Equivalent: Angelica dahurica (Dry)

436.97 mg/g

Coix lachryma-jobi seed Extract dry concentrate

47.83 mg/g

Equivalent: Coix lachryma-jobi (Dry)

511.74 mg/g

Dolichos lablab flower Extract dry concentrate

26.09 mg/g

Equivalent: Dolichos lablab (Dry)

185.22 mg/g

Elsholtzia splendens herb top Extract dry concentrate

30.43 mg/g

Equivalent: Elsholtzia splendens (Dry)

435.22 mg/g

Public Summary

Page 2 of

Produced at 12.01.2021 at 12:17:06 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

Gardenia jasminoides fruit Extract dry concentrate

86.96 mg/g

Equivalent: Gardenia jasminoides (Dry)

869.56 mg/g

Glycine max seed Extract dry concentrate

86.96 mg/g

Equivalent: Glycine max (Dry)

869.6 mg/g

Glycyrrhiza uralensis root and rhizome Extract dry concentrate

73.91 mg/g

Equivalent: Glycyrrhiza uralensis (Dry)

443.48 mg/g

Houttuynia cordata herb Extract dry concentrate

39.12 mg/g

Equivalent: Houttuynia cordata (Dry)

532.17 mg/g

Imperata cylindrica rhizome Extract dry concentrate

73.91 mg/g

Equivalent: Imperata cylindrica (Dry)

443.48 mg/g

Lonicera japonica flower Extract dry concentrate

56.52 mg/g

Equivalent: Lonicera japonica (Dry)

435.22 mg/g

Lophatherum gracile herb Extract dry concentrate

43.48 mg/g

Equivalent: Lophatherum gracile (Dry)

621.74 mg/g

Nelumbo nucifera leaf Extract dry concentrate

26.08 mg/g

Equivalent: Nelumbo nucifera (Dry)

782.61 mg/g

Phragmites australis rhizome Extract dry concentrate

34.78 mg/g

Equivalent: Phragmites australis (Dry)

434.78 mg/g

Platycodon grandiflorus root Extract dry concentrate

86.96 mg/g

Equivalent: Platycodon grandiflorus (Dry)

347.83 mg/g

Prunus persica seed Extract dry concentrate

30.43 mg/g

Equivalent: Prunus persica (Dry)

152.17 mg/g

Siraitia grosvenorii fruit Extract dry concentrate

73.91 mg/g

Equivalent: Siraitia grosvenorii (Dry)

443.48 mg/g

Zingiber officinale rhizome Extract dry concentrate

73.91 mg/g

Equivalent: Zingiber officinale (Fresh)

443.48 mg/g

© 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 12.01.2021 at 12:17:06 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

Similar products

Search alerts related to this product

Share this information