Vitamin

Main information

Documents

Localization

  • Available in:
  • Vitamin C 1000 Plus
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217937
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217937

Vitamin C 1000 Plus

ARTG entry for

Medicine Listed

Sponsor

Bio Nourish Pty Ltd

Postal Address

PO Box 216,TERRIGAL, NSW, 2260

Australia

ARTG Start Date

2/12/2013

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. Vitamin C 1000 Plus

Product Type

Single Medicine Product

Effective date

2/12/2013

Warnings

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

Standard Indications

Relief of the symptoms of colds. [Warnings S and COLD required]

May help reduce the severity of the symptoms of colds. ]Warnings S and COLD required]

May reduce the severity of colds. [Warning COLD required]

May reduce the duration of colds. [Warning COLD required]

May reduce the severity and duration of colds. [Warning COLD required]

May assist in the maintenance of cholesterol within the normal range in healthy individuals.

May assist in the maintenance of normal/healthy cholesterol levels in healthy individuals.

May assist in the maintenance of cholesterol within the normal/healthy range in healthy individuals and improve the LDL:HDL ratio.

May assist in the maintenance of a normal/healthy LDL:HDL cholesterol ratio.

May help reduce the oxidation of LDL cholesterol.

For vitamin (may state the vitamin) supplementation.

Maintain health of capillaries.

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

Protects capillaries.

Specific Indications

* Maintains a normal/healthy cardiovascular system.

* Vitamin C is essential for the proper function of the immune system.

* Maintains a normal/healthy immune system.

* Vitamin C maintains immune health by supporting the activity of the white blood cells and antibody response.

Public Summary

Page 1 of

Produced at 23.11.2017 at 03:50:59 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

* Vitamin C plays a vital role in many immune mechanisms and antibody response.

* Vitamin C is necessary for the manufacture of collagen in the body.

* Vitamin C plays a role in collagen formation.

* Vitamin C supports the development and maintenance of bones.

* Vitamin C supports the development and maintenance of teeth.

* Vitamin C supports the development and maintenance of cartilage.

* Vitamin C supports connective tissue formation.

* Vitamin C is an important nutritional antioxidant/free radical scavenger.

* As an antioxidant, vitamin C assists in protecting the body from the damaging effects of free radicals.

* Vitamin C is a potent antioxidant that can reduce the risk of cellular damage from free radicals.

* Vitamin C is necessary for wound healing.

* Vitamin C is necessary for the maintenance of healthy skin.

* Assists in the healing and repair of the skin.

* Vitamin C may reduce susceptibility to bruising.

* Vitamin C can regenerate oxidized vitamin E in the body.

* Vitamin C is necessary for healthy gums.

* Lifestyle factors such as stress and cigarettes may increase the body's vitamin C requirements.

* Vitamin C improves iron absorption.

* Vitamin C aids in the metabolism of fats and proteins.

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

Ascorbic acid

400 mg

calcium ascorbate dihydrate

400 mg

Citrus bioflavonoids extract

25 mg

Hesperidin

50 mg

Malpighia glabra

12.5 mg

Equivalent: Malpighia glabra (Fresh)

218.75 mg

Rosa canina

42 mg

Equivalent: Rosa canina (Dry)

252 mg

rutoside

50 mg

sodium ascorbate

350 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 03:50:59 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