PRICELINE PHARMACY PARACETAMOL AND IBUPROFEN film coated tablet blister pack

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

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Active ingredient:
ibuprofen,paracetamol
Available from:
Soul Pattinson Manufacturing Pty Ltd
INN (International Name):
Ibuprofen,Paracetamol
Authorization status:
Registered
Authorization number:
291489

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Public Summary

Summary for ARTG Entry:

291489

PRICELINE PHARMACY PARACETAMOL & IBUPROFEN film coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Soul Pattinson Manufacturing Pty Ltd

Postal Address

Locked Bag 5061,PARRAMATTA, NSW, 2124

Australia

ARTG Start Date

13/07/2017

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. PRICELINE PHARMACY PARACETAMOL & IBUPROFEN film coated tablet blister pack

Product Type

Single Medicine Product

Effective date

13/07/2017

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Temporary relief of acute (short term) pain and / or inflammation associated with headache, migraine headache, tension headache, sinus pain,

toothache, dental procedures, backache, muscular aches and pains, period pain, sore throat, tennis elbow, rheumatic pain and arthritis, and the aches

and pains associated with colds and flu. Reduces fever.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

36 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S2) Pharmacy Medicine

(S3) Pharmacist Only Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off-white, oval shaped, biconvex, film-coated pearlescent tablets

plain on both sides

Active Ingredients

Ibuprofen

200 mg

Paracetamol

500 mg

© 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 24.11.2017 at 07:59:17 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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