Berocca

Main information

Documents

Localization

  • Available in:
  • Berocca Boost with guarana
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218721
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218721

Berocca Boost with guarana

ARTG entry for

Medicine Listed

Sponsor

Bayer Australia Ltd

Postal Address

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

Australia

ARTG Start Date

20/12/2013

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. Berocca Boost with guarana

Product Type

Single Medicine Product

Effective date

24/12/2015

Warnings

Phenylketonurics are warned that this product contains phenylalanine (or words to that effect).

Contains caffeine [state quantity per dosage unit or per mL or per gram of product] [must be clear and legible].

Contains aspartame.

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 words to that effect).

Standard Indications

Specific Indications

Helps increase alertness

Helps improve cognitive speed

Helps reduce mental fatigue

Helps improve mental sharpness.

Helps increase/enhance energy

Helps to improve concentration

Helps improve accuracy

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Tablet, effervescent

Route of Administration

Public Summary

Page 1 of

Produced at 26.11.2017 at 04:31:59 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

Oral

Visual Identification

Active Ingredients

Ascorbic acid

60 mg

Biotin

150 microgram

Caffeine

72.7 mg

Calcium carbonate

248.3 mg

Calcium pantothenate

6.52 mg

Cyanocobalamin

.001 mg

Folic acid

200 microgram

magnesium carbonate hydrate

159.8 mg

magnesium sulfate dihydrate

386.1 mg

monophosphothiamine dihydrate

2.2 mg

Nicotinamide

18 mg

Paullinia cupana

40 mg

Equivalent: Paullinia cupana (Dry)

120 mg

pyridoxine hydrochloride

2.43 mg

riboflavine sodium phosphate

2.18 mg

zinc citrate trihydrate

30.43 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 04:31:59 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