Swisse

Main information

  • Trade name:
  • Swisse Ultiboost Zinc + Vitamin C + Garlic
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Swisse Ultiboost Zinc + Vitamin C + Garlic
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220773
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220773

Swisse Ultiboost Zinc + Vitamin C + Garlic

ARTG entry for

Medicine Listed

Sponsor

Swisse Wellness Pty Ltd

Postal Address

111 Cambridge Street,Collingwood, VIC, 3066

Australia

ARTG Start Date

6/03/2014

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. Swisse Ultiboost Zinc + Vitamin C + Garlic

Product Type

Single Medicine Product

Effective date

17/12/2015

Warnings

If symptoms persist consult your healthcare practitioner (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).

Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.

Adults only. OR Not to be used in children under two years of age without medical advice (or words to that effect).

Standard Indications

Specific Indications

Zinc is required by the body for general good health/wellbeing. Zinc helps/supports/helps maintain/assists good health/general wellbeing.

Zinc helps to maintain/support a healthy immune system/function/response.

Vitamin C may help to reduce/relieve severity of symptoms associated with the common cold. /May help to reduce/relieve the severity of common cold

symptoms.

Zinc may help to reduce/relieve severity of symptoms associated with the common cold. /May help to reduce/relieve the severity of common cold

symptoms.

Vitamin C helps to reduce the duration and severity of common cold symptoms.

Zinc helps to reduce the duration and severity of common cold symptoms.

Vitamin C helps/supports/assists/helps maintain good health/general wellbeing.

The antioxidant properties of vitamin C help to maintain good

health/general wellbeing. / As an antioxidant, vitamin C helps to protect cells from oxidative damage/free radical damage.

Vitamin C helps to regulate normal/healthy immune function./Vitamin C helps to support healthy immune function/system. / Vitamin C is

important/essential for maintaining/supporting a healthy immune response.

Vitamin C is found in high concentrations in the adrenal glands. It is important for the synthesis of hormones involved in the stress response. / Provides

adrenal support during stress.

Garlic has antioxidant activity/is an antioxidant/has antioxidant properties.

Garlic has been used traditionally in Western Herbal Medicine to help relieve the symptoms associated with cold, upper respiratory tract infections and

catarrhal conditions. / Supports immune health

Public Summary

Page 1 of

Produced at 23.11.2017 at 03:46:28 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

Symptoms associated with the common cold include blocked or runny nose, dry cough and mucous congestion.

The common cold is an upper respiratiory tract infection.

Adequate levels of zinc help to support/help maintain healthy skin and minor wound healing.

Zinc also plays a role in the maintenance of taste and smell

Zinc helps to support/assists the metabolism of proteins, fats and carbohydrates.

The vitamin C is derived from non-acidic/buffered calcium ascorbate form, making it gentle on the stomach.

Vitamin C is water soluble, therefore is not stored in large amounts in the body. The human body is unable to synthesis it's own vitamin C therefore

regular/daily intake is desirable.

Vitamin C helps with the formation of connective tissue and healing process of minor wounds

Vitamin C plays an integral/imprtantl role in the formation of the strong and elastic structure of collagen and elastin. Collagen and elastin are essential for

the maintenance of healthy skin, bones, tendons, cartilage and gums.

Garlic has been traditionally used in Western Herbal Medicine for its antibacterial properties.

The immune system is composed of cells and molecules organised into specialised tissues, which act as the body's first line of defence.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Active Ingredients

Allium sativum

11 mg

Equivalent: Allium sativum (Fresh)

1.1 g

calcium ascorbate dihydrate

605.19 mg

zinc amino acid chelate

62.5 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 23.11.2017 at 03:46:28 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

17-11-2018

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