TRUST

Main information

  • Trade name:
  • TRUST FOR KIDS IBUPROFEN INFANT DROPS ibuprofen 40 mg/mL oral suspension bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TRUST FOR KIDS IBUPROFEN INFANT DROPS ibuprofen 40 mg/mL oral suspension bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222895
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222895

TRUST FOR KIDS IBUPROFEN INFANT DROPS ibuprofen 40 mg/mL oral suspension bottle

ARTG entry for

Medicine Registered

Sponsor

Pharmacor Pty Ltd

Postal Address

Suite 501,7 Oaks Ave,Dee Why, NSW, 2099

Australia

ARTG Start Date

29/04/2014

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. TRUST FOR KIDS IBUPROFEN INFANT DROPS ibuprofen 40 mg/mL oral suspension bottle

Product Type

Single Medicine Product

Effective date

14/09/2017

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Temporary relief of pain associated with teething, immunisation, earache, colds and flu, sore throat, minor aches and headache. Reduces fever.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Polyethylene

Terephthalate

24 Months

Store below 25

degrees Celsius

Child resistant closure

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

50 mL

(S2) Pharmacy Medicine

Components

1.

Dosage Form

Oral Liquid, suspension

Route of Administration

Oral

Visual Identification

Off white coloured uniform suspension with a characteristic strawberry

flavour

Active Ingredients

Ibuprofen

40 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 10:48:09 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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