Bosisto's

Main information

  • Trade name:
  • Bosisto's Echinacea Throat Spray Honey and Lemon
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Bosisto's Echinacea Throat Spray Honey and Lemon
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218466
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218466

Bosisto's Echinacea Throat Spray Honey and Lemon

ARTG entry for

Medicine Listed

Sponsor

Felton Grimwade & Bosisto's Pty Ltd

Postal Address

PO Box 74,OAKLEIGH SOUTH, VIC, 3167

Australia

ARTG Start Date

12/12/2013

Product category

Medicine

Status

Active

Approval area

Listed Medicines

Conditions

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. Bosisto's Echinacea Throat Spray Honey and Lemon

Product Type

Single Medicine Product

Effective date

12/12/2013

Warnings

(If the medicine contains one sorbate) Contains [insert name of sorbate] OR (if medicine contains two or more sorbates) Contains sorbates [or words to

that effect].

Not suitable for infants under the age of twelve months (or words to that effect).

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

If coughing persists consult your doctor (or a healthcare professional) (or words to that effect).

Adults only. OR Not to be used in children under two years of age without medical advice (or words to that effect).

Adults only. OR Not to be used in children under two years of age without medical advice (or words to that effect).

(If medicine contains one sugar) contains [insert name of sugar] OR (If medicine contains two or more sugars) Contains sugars [or words to that effect].

Contains ethanol. (or words to that effect).

Standard Indications

Relief of coughs. [Warnings COU1 and COU2 required]

Temporary relief of coughs. [Warnings COU1 and COU2 required]

Relief of symptoms of mild upper respiratory infections. [Warnings S and COLD required]

For the symptomatic relief of upper respiratory tract infections. [Warnings S and COLD required]

May reduce the severity and duration of colds. [Warning COLD required]

May assist in the management of upper respiratory tract infections. [Warnings S and COLD required]

Relief of the symptoms of colds. [Warnings S and COLD required]

May assist in the management of sore throat. [Warning S required]

For the symptomatic relief of sore throat. [Warning S required]

May help reduce the severity of the symptoms of colds. ]Warnings S and COLD required]

Specific Indications

Relieves the symptoms of a sore throat.

Helps manage a sore throat.

Relaxes the throat and coughing reflexes.

Fast, natural sore throat reflief plus Immune support.

Help to soothe and relieve irritation from a sore throat.

Public Summary

Page 1 of

Produced at 26.11.2017 at 04:44:54 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

Immune support.

Immune support that helps the body fight the underlying cause of a sore throat.

Help stimulate the immune system to help the body fight the underlying cause of a sore throat.

The dual action comforts the symptoms and helps stimulate the body's immune system to help fight a sore throat.

Soothe a sore throat.

Helps reduce the servity of cold symptoms, provides temporary reflief of coughs and soothes and comforts a sore throat naturally.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Formulation 1

Dosage Form

Spray

Route of Administration

Oral

Oral Application

Visual Identification

Active Ingredients

Echinacea angustifolia

55.35 mg/mL

Equivalent: Echinacea angustifolia (Dry)

28.75 mg/mL

Echinacea purpurea

55.35 mg/mL

Equivalent: Echinacea purpurea (Dry)

28.75 mg/mL

Honey

550 mg/mL

© 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 04:44:54 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

24-4-2018

One lot of Traditional Medicinals "Throat Coat Lemon Echinacea" herbal tea recalled because of potential contamination with Salmonella

One lot of Traditional Medicinals "Throat Coat Lemon Echinacea" herbal tea recalled because of potential contamination with Salmonella

Health Canada is advising Canadians that one lot of “Throat Coat Lemon Echinacea” herbal tea is being voluntarily recalled by Traditional Medicinals after a company supplier found Salmonella contamination in a tea ingredient (lemon myrtle leaf). An infection caused by Salmonella bacteria may pose serious health risks, particularly for young children, pregnant women, the elderly and people with weak immune systems.

Health Canada