GOLD

Main information

  • Trade name:
  • GOLD CROSS PAIN RELIEF ANALGESIC/CALMATIVE tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GOLD CROSS PAIN RELIEF ANALGESIC/CALMATIVE tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220519
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220519

GOLD CROSS PAIN RELIEF ANALGESIC/CALMATIVE tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Biotech Pharmaceuticals Pty Ltd

Postal Address

83 Cherry Lane,LAVERTON NORTH, VIC, 3026

Australia

ARTG Start Date

26/02/2014

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. GOLD CROSS PAIN RELIEF ANALGESIC/CALMATIVE tablet blister pack

Product Type

Single Medicine Product

Effective date

20/08/2015

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For the temporary relief of moderate to severe pain and discomfort associated with: tension headache, toothache, backache, neuralgia, migraine

headache, period pain, muscle pain, rheumatic pain and pain associated with trauma or surgery and other pains where a combined calmative &analgesic

action is required.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Not recorded

3 Years

Store below 25

degrees Celsius

Not recorded

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

50 Tablets

(S3) Pharmacist Only Medicine

40 Tablets

(S3) Pharmacist Only Medicine

70 Tablets

(S3) Pharmacist Only Medicine

20 Tablets

(S3) Pharmacist Only Medicine

Components

1.

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

White, capsule shaped, biconvex tablets with a central break line on one

side and plain on the other side.

Active Ingredients

codeine phosphate hemihydrate

10 mg

doxylamine succinate

5.1 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 26.11.2017 at 02:23:32 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