Main information



  • Available in:
  • Berocca Performance Mango and Orange
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216396
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Berocca Performance Mango and Orange

ARTG entry for

Medicine Listed


Bayer Australia Ltd

Postal Address

PO Box 182,Gordon NSW 2072,Gordon, NSW, 2072


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. Berocca Performance Mango and Orange

Product Type

Single Medicine Product

Effective date



Contains aspartame.

Phenylketonurics are warned that this product contains phenylalanine (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.

If symptoms persist consult your healthcare practitioner (or words to that effect).

Standard Indications

Specific Indications

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

Assists in normal blood function.

Assists in the functioning of the digestive system, nervous system, heart, muscles and skin.

May be beneficial during times of increased stress.

May reduce cold symptoms.

Antioxidant activity.

Helps support immune responses.

Helps converts carbohydrates, fats and protein into energy.

Helps release energy from food.

Prolonged use increases the overall well-being of an individual.

Helps in reducing anxiety and stress.

Helps improve concentration.

Helps reduce tiredness and fatigue.

Helps reduce mental tiredness and mental fatigue.

Helps improve mental stamina.

Helps improve alertness.

Helps improve mood.

Helps improve activity and fitness.

Helps enhance physical performance.

Helps enhance mental performance.

Helps improve cognitive function.

Helps improve physical stamina.

Helps you be at the top of your game both mentally and physically.

Helps improve mental sharpness.

Public Summary

Page 1 of

Produced at 26.11.2017 at 07:25:37 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.

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Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule


1. Formulation 1

Dosage Form

Tablet, effervescent

Route of Administration


Visual Identification

Active Ingredients

Ascorbic acid

500 mg


150 microgram

Calcium carbonate

244 mg

Calcium pantothenate

25 mg


.01 mg

Folic acid

400 microgram

magnesium carbonate hydrate

195.8 mg

magnesium sulfate dihydrate

328.19 mg

monophosphothiamine dihydrate

18.54 mg


50 mg

pyridoxine hydrochloride

10 mg

riboflavine sodium phosphate

20.5 mg

zinc citrate trihydrate

32.03 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 26.11.2017 at 07:25:37 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