Herb-A-Lax

Australia - English - Department of Health (Therapeutic Goods Administration)

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Active ingredient:
Anethum graveolens,Frangula bark dry,Liquorice Dry,Psyllium Husk Dry,Senna leaf dry
Available from:
Phytologic Holdings Pty Ltd
Authorization status:
Listed
Authorization number:
324008

Public Summary

Summary for ARTG Entry:

324008

Herb-A-Lax

ARTG entry for

Medicine Listed

Sponsor

Phytologic Holdings Pty Ltd

Postal Address

PO Box 6193,Alexandria, NSW, 2015

Australia

ARTG Start Date

25/09/2019

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. Herb-A-Lax

Product Type

Single Medicine Product

Effective date

25/09/2019

Permitted Indications

Decrease/reduce/relieve constipation

Aperient/laxative

Helps reduce occurrence of constipation

Promote/increase bowel evacuation

Stimulant laxative

Enhance/improve/promote/increase bowel regularity

Maintain/support bowel regularity

Enhance/improve/promote/increase bowel waste elimination

Decrease/reduce/relieve bowel discomfort

Decrease/reduce/relieve flatulence/carminative

Decrease/reduce/relieve abdominal bloating/distention

Helps reduce occurrence of abdominal bloating

Decrease/reduce/relieve abdominal pain/discomfort

Relieve digestive discomfort

Indication Requirements

Product presentation must not imply or refer to gastro oesophageal reflux disease.

Label statement: If symptoms persist, talk to your health professional.

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

Label statement: Do not use when abdominal pain, nausea or vomiting are present or if you develop diarrhoea. If you are pregnant or breastfeeding - seek

the advice of a healthcare professional before

Public Summary

Page 1 of

Produced at 29.09.2019 at 04:08:43 AEST

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

Label statement for stimulant laxatives: Prolonged use may cause serious bowel problems.

Product presentation must not refer to or imply weight loss.

Standard Indications

No Standard Indications included on Record

Specific Indications

Warnings

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).

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

Use in children under 12 years is not recommended.

Prolonged use may cause serious bowel problems.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Herb, dried

Route of Administration

Oral

Visual Identification

Active Ingredients

Anethum graveolens

20 mg/g

Frangula bark dry

70 mg/g

Liquorice Dry

20 mg/g

Psyllium Husk Dry

20 mg/g

Senna leaf dry

870 mg/g

© 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 29.09.2019 at 04:08:43 AEST

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

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