NOUMED IBUPROFEN SUSPENSION FOR CHILDREN 3 MONTHS TO 5 YEARS 20 mg/mL oral suspension bottle

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

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Active ingredient:
citric acid monohydrate,ibuprofen
Available from:
AVALLON PHARMACEUTICALS PTY LTD
Authorization status:
Registered
Authorization number:
349530

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Public Summary

Summary for ARTG Entry:

349530

NOUMED IBUPROFEN SUSPENSION FOR CHILDREN 3 MONTHS TO 5 YEARS 20 mg/mL oral

suspension bottle

ARTG entry for

Medicine Registered

Sponsor

AVALLON PHARMACEUTICALS PTY LTD

Postal Address

Level 5 ;, 7 Eden Park Drive, Macquarie Park, NSW, 2113

Australia

ARTG Start Date

24/11/2020

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 . NOUMED IBUPROFEN SUSPENSION FOR CHILDREN 3 MONTHS TO 5 YEARS 20 mg/mL oral suspension

bottle

Product Type

Single Medicine Product

Effective Date

24/11/2020

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

For the temporary relief of pain associated with teething, toothache, earache, headache, sore throats, symptoms of cold & flu, minor aches, sprains &

strains and immunisation. Reduces fever.

Warnings

No Warnings included on Record

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Glass

20 Months

Store below 30

degrees Celsius

Child resistant closure

Not recorded

Bottle

Polyethylene

Terephthalate

20 Months

Store below 30

degrees Celsius

Child resistant closure

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

100 mL

(S2) Pharmacy Medicine

200 mL

(S2) Pharmacy Medicine

Components

1 .

Dosage Form

Suspension

Route of Administration

Oral

Visual Identification

A white to off-white syrupy suspension.

Active Ingredients

Public Summary

Page 1 of

Produced at 11.01.2021 at 10:10:13 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

citric acid monohydrate

0 QS

ibuprofen

20 mg/mL

Other Ingredients (Excipients)

domiphen bromide

Flavour

glycerol

maltitol solution

polysorbate 80

purified water

saccharin sodium

sodium chloride

sodium citrate dihydrate

xanthan gum

© 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 11.01.2021 at 10:10:13 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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