INFANTS'

Main information

  • Trade name:
  • INFANTS' FRIEND oral liquid bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • INFANTS' FRIEND oral liquid bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 26678
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

26678

INFANTS' FRIEND oral liquid bottle

ARTG entry for

Medicine Registered

Sponsor

Infant's Friend Pty Ltd

Postal Address

PO Box 268,BOOVAL DC, QLD, 4304

Australia

ARTG Start Date

30/10/1991

Product category

Medicine

Status

Active

Approval area

Office of Complementary Medicine

Conditions

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

Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989"

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. INFANTS' FRIEND oral liquid bottle

Product Type

Single Medicine Product

Effective date

11/07/2017

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Relieve colic and wind in the bowels.,Help to allay restlessness and irritation caused by by inflamed gums during teething.,Help to keep the bowels

regular.,Produce natural quiet sleep, by relieving the child from colic.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

2 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

100mL

Not scheduled. Not considered by committee

Components

1.

Dosage Form

Oral Liquid

Route of Administration

Oral

Visual Identification

Pale yellow mixture with white sediment in 100 mL. Brown glass.

Active Ingredients

Ammonium bicarbonate

1 mg/mL

Anise Oil

.26 mL/L

Cassia Oil

.39 mL/L

Dill Seed Oil

.13 mL/L

magnesium carbonate hydrate

22.2 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 01.12.2017 at 09:34:59 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

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