BLOOMS HERB-A-LAX Capsules

Main information

  • Trade name:
  • BLOOMS HERB-A-LAX Capsules
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BLOOMS HERB-A-LAX Capsules
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Listed
  • Authorization number:
  • 172527
  • Last update:
  • 23-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

172527

BLOOMS HERB-A-LAX Capsules

ARTG entry for

Medicine Listed

Sponsor

Phytologic Holdings Pty Ltd

Postal Address

PO Box 6193,Alexandria, NSW, 2015

Australia

ARTG Start Date

24/06/2010

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. BLOOMS HERB-A-LAX Capsules

Product Type

Single Medicine Product

Effective date

25/07/2016

Warnings

Drink plenty of water (or words to that effect).

Prolonged use may cause serious bowel problems.

Use in children under 12 years is not recommended.

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

Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a

healthcare professional before taking this product (or words to that effect).

Standard Indications

Specific Indications

As an aid in the management of constipation.

Blooms Herb-a-Lax is a gentle yet effective combination of Senna leaf, Buckthorn Bark, Psyllium seed, Dill seed and Liquorice root powder to form a

natural herbal laxative. Psyllium seed provides a great source of fibre and together with liquorice root powder has a gentle soothing action on the bowel.

Dill seed has a calmative action on the bowel and helps to settle intestinal distress and bloating.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Active Ingredients

Public Summary

Page 1 of

Produced at 29.11.2017 at 05:32:28 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

Anethum graveolens

6 mg

Glycyrrhiza glabra

6 mg

Psyllium Husk Powder

6 mg

Rhamnus frangula

23 mg

Senna Leaf Powder

284 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 29.11.2017 at 05:32:28 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