Infant Coleze

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

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Active ingredient:
Caraway Oil,Dill Seed Oil
Available from:
Contract Manufacturing & Packaging Services Pty Ltd
INN (International Name):
Caraway Oil,Dill Seed Oil
Authorization status:
Listed
Authorization number:
293403

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Public Summary

Summary for ARTG Entry:

293403

Infant Coleze

ARTG entry for

Medicine Listed

Sponsor

Contract Manufacturing & Packaging Services Pty Ltd

Postal Address

20 - 22 Long Street,SMITHFIELD, NSW, 2164

Australia

ARTG Start Date

31/08/2017

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. Infant Coleze

Product Type

Single Medicine Product

Effective date

31/08/2017

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].

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

Standard Indications

Aids, assists or helps in the maintenance of general well-being

Specific Indications

Contains caraway oil, traditionally used in herbal medicine for minor colic in infants.

Contains Caraway, which is traditionally used in herbal medicine to help relieve mild infantile colic and flatulence.

Contains Caraway oil, traditionally used in herbal medicine to help relieve intestinal colic (antispasmodic).

Contains Caraway oil, traditionally used in Herbal Medicine to help relieve minor digestive disturbances including bloating, feeling of fullness and

flatulence.

Contains Caraway oil, traditionally used in herbal medicine to help relieve mild digestive upset/ disturbances including dyspepsia and flatulent colic

Contains Caraway oil, traditionally used in herbal medicine to assist in the management of mild, spasmodic gastrointestinal complaints such as flatulence

and colic.

Contains Caraway oil, traditionally used in Herbal Medicine to help relieve minor spasmodic gastro-intestinal complaints.(Antispasmodic)

Contains Caraway oil, traditionally used in Herbal Medicine as a carminative to the gastro-intestinal tract.

Contains Caraway oil, traditionally used in herbal medicine as a digestive stimulant.

Contains Caraway oil, traditionally used in herbal medicine as a digestive aid

Contains Caraway oil, traditionally used in herbal medicine to help stimulate the appetite.

Contains Caraway oil, traditionally used in herbal medicine as an expectorant to help relieve excess mucous of the respiratory passage.

Contains Dill oil, traditionally used in herbal medicine for dyspeptic complaints.

Contains Dill oil, traditionally used in herbal medicine to help relieve mild digestive upset/ disturbances including dyspepsia and flatulent colic

Contains Dill oil, traditionally used in herbal medicine to help relieve mild digestive disturbances such as flatulent dyspepsia (carminative)

Contains Dill oil, traditionally used in herbal medicine to help relieve mild digestive disturbances such as bloating, dyspepsia, flatulence and colic

Contains Dill oil, traditionally used in herbal medicine to help relieve intestinal colic (antispasmodic)

Contains Dill oil, traditionally used in herbal medicine for symptomatic relief of mild digestive disorders such dyspepsia, colic and flatulence

Contains Dill oil, traditionally used in herbal medicine to assist in the management of mild, spasmodic gastrointestinal complaints such as flatulence and

colic.

Contains Dill oil, traditionally used in herbal medicine to help relieve flatulence/ to help expel intestinal gas (carminative)

Public Summary

Page 1 of

Produced at 24.11.2017 at 06:23:44 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

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Multiple containers

Not recorded

Not recorded

Not recorded

Neither child resistant

closure nor restricted

flow insert

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Active Ingredients

Caraway Oil

25 mg

Dill Seed Oil

4.5 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 24.11.2017 at 06:23:44 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

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