PHARMACY HEALTH FEXOFENADINE HAYFEVER & ALLERGY RELIEF fexofenadine hydrochloride 180 mg tablet blister pack

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

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Active ingredient:
fexofenadine hydrochloride
Available from:
Soul Pattinson Manufacturing Pty Ltd
INN (International Name):
Fexofenadine hydrochloride
Authorization status:
Registered
Authorization number:
294220

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Public Summary

Summary for ARTG Entry:

294220

PHARMACY HEALTH FEXOFENADINE HAYFEVER & ALLERGY RELIEF fexofenadine hydrochloride 180

mg 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

21/09/2017

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. PHARMACY HEALTH FEXOFENADINE HAYFEVER & ALLERGY RELIEF fexofenadine hydrochloride 180 mg

tablet blister pack

Product Type

Single Medicine Product

Effective date

21/09/2017

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Relief of symptoms associated with seasonal allergic rhinitis or urticaria for adults and children aged 12 years and over.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PE/PCTFE

(Aclar)/Al

3 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Blister Pack

PVC/PVDC/Al

3 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S2) Pharmacy Medicine

(S2) Pharmacy Medicine

(S2) Pharmacy Medicine

(S2) Pharmacy Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Peach coloured, caplet shaped film-coated tablet debossed as '180' on one

side and plain on other side.

Active Ingredients

Fexofenadine hydrochloride

180 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 05:41:23 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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