Main information



  • Available in:
  • AMCAL VITAMIN B+C Effervescent Energy Support
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220787
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


AMCAL VITAMIN B+C Effervescent Energy Support

ARTG entry for

Medicine Listed


Sigma Company Limited

Postal Address

PO Box 2890,ROWVILLE, VIC, 3178


ARTG Start Date


Product category




Approval area

Listed Medicines


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


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.


1. AMCAL VITAMIN B+C Effervescent Energy Support

Product Type

Single Medicine Product

Effective date



Contains saccharin sodium (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

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

For the symptomatic relief of hangover.

Prevention/treatment of vitamin [XX] and/or mineral [YY] and/or nutritional deficiencies (This indication is not be to used for the treatment of iron

deficiency conditions).

Specific Indications

Today's busy and stressful lifestyle has many people working too hard, drinking, smoking and not getting enough sleep. This may lead to an inadequate

diet whereby your body may not be receiving sufficient levels of essential nutrients including B group and C Vitamins.

Amcal Vitamin B+C Effervescent tablets contain a balanced formulation of B group vitamins plus vitamin C. Its great citrus taste makes it refreshing to


The effervescent dosage form allows for rapid release action.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule


1. Formulation 1

Dosage Form

Tablet, effervescent

Route of Administration


Visual Identification

Public Summary

Page 1 of

Produced at 22.11.2017 at 11:28:49 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 for contact information

Active Ingredients

Ascorbic acid

1 g


150 microgram

Calcium carbonate

157.5 mg

Calcium pantothenate

25 mg


10 microgram


50 mg

pyridoxine hydrochloride

10 mg

riboflavine sodium phosphate

15 mg

Thiamine nitrate

15 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

Public Summary

Page 2 of

Produced at 22.11.2017 at 11:28:49 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 for contact information