B complex

Main information

  • Trade name:
  • B complex Stress Release with Theanine
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • B complex Stress Release with Theanine
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 214303
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

214303

B complex Stress Release with Theanine

ARTG entry for

Medicine Listed

Sponsor

RBK Nutraceuticals Pty Ltd

Postal Address

46 Powers Road,SEVEN HILLS, NSW, 2147

Australia

ARTG Start Date

9/09/2013

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. B complex Stress Release with Theanine

Product Type

Single Medicine Product

Effective date

9/09/2013

Warnings

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

Helps relieve nervous tension, stress and mild anxiety. [Warning S required]

Herbal blend which helps relieve stress of study or work. [Warning S required]

Non-vitamin active ingredients may improve stress adaptation.

Non-vitamin active ingredients in this product may be beneficial during times of stress. [Warning S required]

Non-vitamin active ingredients in this product help relieve nervous tension, stress and mild anxiety. [Warning S required]

For the symptomatic relief of stress disorders. [Warning S required]

May assist in the management of stress disorders. [Warning S required]

Beneficial during times of stress. [Warning S required]

Specific Indications

Theanine is an amino acid contained in green tea or black tea leaves which has been known to have a influence on brain activity such as reducing stress

. Also well known for its antioxidant properties, theanine may help relax the mind and relieve nervous tension. B group vitamins play important role in

relieving stress and mild anxiety. Vitamin B5 (Pantothenic Acid) is called as Anti-stress vitamin because of its role in the creation of stress hormones.

Vitamin B6 (Pyridoxine) is involved in the production of brain chemical serotonin. Theanine with Vitamin B complex may be beneficial during the times of

stress.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Public Summary

Page 1 of

Produced at 22.11.2017 at 11:47:09 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

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

Calcium pantothenate

20 mg

Camellia sinensis

125 mg

Cyanocobalamin

.005 mg

pyridoxine hydrochloride

2 mg

Riboflavin

5 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 22.11.2017 at 11:47:09 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

5-6-2018

Camellia sinensis (green tea) extract

Camellia sinensis (green tea) extract

Safety advisory - potential risk of harm to the liver

Therapeutic Goods Administration - Australia

There are no news related to this product.