AMCAL

Main information

Documents

Localization

  • Available in:
  • AMCAL ONCE DAILY MULTIVITAMIN & MINERALS
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 215741
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

215741

AMCAL ONCE DAILY MULTIVITAMIN & MINERALS

ARTG entry for

Medicine Listed

Sponsor

Sigma Company Limited

Postal Address

PO Box 2890,ROWVILLE, VIC, 3178

Australia

ARTG Start Date

8/10/2013

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. AMCAL ONCE DAILY MULTIVITAMIN & MINERALS

Product Type

Single Medicine Product

Effective date

8/10/2013

Warnings

If symptoms persist, seek the advice of a healthcare professional.

Contains [amount of potassium in milligrams] mg of potassium. If you have kidney disease or are taking heart or blood pressure medicines, consult your

doctor or pharmacist before use. Keep out of reach of children.

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).

This product contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not

be exceeded.

WARNING - When taken in excess of 3000 micrograms retinol equivalents, vitamin A can cause birth defects.

The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents

for men.

If you are pregnant, or considering becoming pregnant, do not take vitamin A supplements without consulting your doctor or pharmacist.

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

Keep out of reach of children (or words to that effect).

(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].

Standard Indications

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

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

Specific Indications

Amcal Once Daily Multi Vitamin and Minerals is a specifically formulated combination of 26 active ingredients including B group vitamins to assist energy

production, key antioxidants for immune support, and nutrients for healthy skin, eyes, bones and heart. Amcal Once Daily Multi Vitamin and Minerals is a

balanced and complete supplement designed to fill nutritional gaps and support general wellbeing.

Additional Product information

Public Summary

Page 1 of

Produced at 26.11.2017 at 08:13:18 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

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

90 mg

Betacarotene

1.8 mg

Biotin

45 microgram

Calcium carbonate

499.5 mg

Calcium pantothenate

10.8 mg

chromic chloride hexahydrate

179.3 microgram

colecalciferol

15 microgram

Cupric sulfate pentahydrate

3.929 mg

Cyanocobalamin

20 microgram

dl-alpha-Tocopheryl acetate

74.5 mg

Ferrous fumarate

15.211 mg

Folic acid

300 microgram

heavy magnesium oxide

82.919 mg

lutein

500 microgram

Lycopene

600 microgram

Manganese sulfate monohydrate

15.38 mg

Nicotinamide

15 mg

Phytomenadione

25 microgram

potassium iodide

196 microgram

Potassium sulfate

178.253 mg

pyridoxine hydrochloride

6 mg

retinol acetate

344.1 microgram

Riboflavin

3.2 mg

sodium selenate

124.8 microgram

Thiamine nitrate

2.689 mg

zinc oxide

9.336 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 26.11.2017 at 08:13:18 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