Chewable Ginger

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

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Active ingredient:
Zingiber officinale
Available from:
Factors Group Australia Pty Ltd
Authorization status:
Listed
Authorization number:
321101

Public Summary

Summary for ARTG Entry:

321101

Chewable Ginger

ARTG entry for

Medicine Listed

Sponsor

Factors Group Australia Pty Ltd

Postal Address

Unit B 10-16 South Street,Rydalmere, NSW, 2116

Australia

ARTG Start Date

31/07/2019

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. Chewable Ginger

Product Type

Single Medicine Product

Effective date

31/07/2019

Permitted Indications

Decrease/reduce/relieve mild rheumatic aches and pains

Helps enhance/improve/promote blood circulation to the peripheral areas of the body (legs, hands and feet)

Traditionally used in Western herbal medicine to decrease/reduce/relieve loss of appetite

Traditionally used in Western herbal medicine to decrease/reduce/relieve flatulence/carminative

Maintain/support healthy digestive system function

Traditionally used in Western herbal medicine to decrease/reduce/relieve symptoms of indigestion/dyspepsia

Traditionally used in Western herbal medicine to decrease/reduce/relieve digestive spasms

Decrease/reduce food stagnation associated with poor or sluggish digestion

Antiemetic/Decrease/reduce/relieve vomiting

Traditionally used in Western herbal medicine to decrease/reduce/relieve nausea

Helps reduce occurrence of symptoms of motion/travel/sea sickness

Decrease/reduce/relieve mild dizziness/vertigo

Relieves mid-cycle menstrual pain

Decrease/reduce/relieve menstrual spasms/cramps

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

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

Traditionally used in Western herbal medicine to antitussive/cough suppressant

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

Indication Requirements

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

Public Summary

Page 1 of

Produced at 29.08.2019 at 05:50:46 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 serious cardiovascular conditions.

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

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

Product presentation must only refer to mild rheumatic aches/pains.

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 gastro oesophageal reflux disease.

Product presentation must only refer to mild vertigo.

Product presentation must not imply or refer to eating disorders.

Standard Indications

No Standard Indications included on Record

Specific Indications

Warnings

Products containing [insert name of sugar alcohol(s)] may have a laxative effect or cause diarrhoea [or words to that effect].

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

Not recorded

Not recorded

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, chewable

Route of Administration

Oral

Visual Identification

Active Ingredients

Zingiber officinale

20 mg

Equivalent: Zingiber officinale (Dry)

500 mg

© 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 29.08.2019 at 05:50:46 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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