AMCAL

Main information

  • Trade name:
  • AMCAL SENEGA & AMMONIA MIXTURE APF14 with Cherry Flavour oral liquid bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AMCAL SENEGA & AMMONIA MIXTURE APF14 with Cherry Flavour oral liquid bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222489
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222489

AMCAL SENEGA & AMMONIA MIXTURE APF14 with Cherry Flavour oral liquid bottle

ARTG entry for

Medicine Registered

Sponsor

Sigma Company Limited

Postal Address

PO Box 2890,ROWVILLE, VIC, 3178

Australia

ARTG Start Date

14/04/2014

Product category

Medicine

Status

Active

Approval area

Non-Prescription Medicines

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. AMCAL SENEGA & AMMONIA MIXTURE APF14 with Cherry Flavour oral liquid bottle

Product Type

Single Medicine Product

Effective date

14/04/2014

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Relieves chesty cough associated with colds, flu and bronchitis.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Glass

2 Years

Store below 30

degrees Celsius

Child resistant closure

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

100mL

Not scheduled. Not considered by committee

500mL

Not scheduled. Not considered by committee

200 mL

Not scheduled. Not considered by committee

Components

1.

Dosage Form

Oral Liquid

Route of Administration

Oral

Visual Identification

Dark brown cloudy liquid

Active Ingredients

Ammonium bicarbonate

25 mg/mL

Senega Root Dry

8.25 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 1 of

Produced at 26.11.2017 at 11:16:25 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