AMCAL

Main information

  • Trade name:
  • AMCAL SINUS PAIN RELIEF PE SINUS DAY & NIGHT tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AMCAL SINUS PAIN RELIEF PE SINUS DAY & NIGHT tablets
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219666
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219666

AMCAL SINUS PAIN RELIEF PE SINUS DAY & NIGHT tablets

ARTG entry for

Medicine Registered

Sponsor

Cipla Australia Pty Ltd

Postal Address

Level 1 / 132-136 Albert Road,SOUTH MELBOURNE, VIC, 3205

Australia

ARTG Start Date

28/01/2014

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. AMCAL SINUS PAIN RELIEF PE SINUS DAY & NIGHT tablets

Product Type

Composite Pack

Effective date

28/01/2014

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For temporary relief of the following symptoms of sinusitis: sinus pain, sinus headache and nasal congestion

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Multiple containers

Not recorded

2 Years

Store below 30

degrees Celsius

Not recorded

Store in a Dry Place

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

24 tablets

(S2) Pharmacy Medicine

Components

1. Amcal Sinus Pain Relief PE Night tablets

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Orange coloured, capsule-shaped, biconvex film coated tablets plain on

both sides

Active Ingredients

chlorphenamine maleate

2 mg

Paracetamol

500 mg

Phenylephrine hydrochloride

5 mg

2. Amcal Sinus Pain Relief PE tablet

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Dark brown, capsule-shaped, biconvex film-coated tablet

Active Ingredients

Paracetamol

500 mg

Phenylephrine hydrochloride

5 mg

Public Summary

Page 1 of

Produced at 26.11.2017 at 03:31:19 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

© 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 26.11.2017 at 03:31:19 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