Manuka-C

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

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Active ingredient:
ascorbic acid,glutathione,Honey,sodium ascorbate,zinc ascorbate
Available from:
Medlab Pty Ltd
Authorization status:
Listed
Authorization number:
350819

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Public Summary

Summary for ARTG Entry:

350819

Manuka-C

ARTG entry for

Medicine Listed

Sponsor

Medlab Pty Ltd

Postal Address

PO Box 6452, ALEXANDRIA, NSW, 2015

Australia

ARTG Start Date

4/12/2020

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 . Manuka-C

Product Type

Single Medicine Product

Effective Date

4/12/2020

Permitted Indications

Maintain/support general health and wellbeing

Maintain/support healthy immune system function

Enhance/improve/promote/increase (state vitamin/mineral/nutrient) levels in the body

Decrease/reduce/relieve common cold duration

Decrease/reduce/relieve the severity of symptoms of mild upper respiratory tract infections

Decrease/reduce/relieve the severity of common cold symptoms

Helps reduce occurrence of symptoms of upper respiratory tract infections

Indication Requirements

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

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 balanced diet.

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

Product presentation must not imply or refer to serious immunological diseases.

Respiratory tract infections must be qualified by 'mild'.

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

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

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].

Not recommended for use by pregnant and lactating women (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 symptoms persist consult your healthcare practitioner (or words to that effect).

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.

Public Summary

Page 1 of

Produced at 11.01.2021 at 09:19:01 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

WARNING: May be dangerous if taken in large amounts or for a long period. OR WARNING: Contains zinc which may be dangerous if taken in large

amounts or for a long period (or words to that effect).

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

Adults only (or words to that effect).

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Powder, oral

Route of Administration

Oral

Visual Identification

Active Ingredients

ascorbic acid

73.89 mg/g

glutathione

25 mg/g

Honey

250 mg/g

sodium ascorbate

11.32 mg/g

Equivalent: ascorbic acid

10 mg/g

Equivalent: sodium

1.32 mg/g

zinc ascorbate

19.11 mg/g

Equivalent: ascorbic acid

16.11 mg/g

Equivalent: zinc

3 mg/g

Other Ingredients (Excipients)

citric acid

colloidal anhydrous silica

Flavour

maltodextrin

silicon dioxide

sodium bicarbonate

sodium carbonate

Stevia rebaudiana

tartaric acid

© 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 11.01.2021 at 09:19:01 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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