TRUST

Main information

  • Trade name:
  • TRUST RESTAMINE doxylamine succinate 25mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TRUST RESTAMINE doxylamine succinate 25mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207746
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207746

TRUST RESTAMINE doxylamine succinate 25mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Pharmacor Pty Ltd

Postal Address

Suite 501,7 Oaks Ave,Dee Why, NSW, 2099

Australia

ARTG Start Date

4/04/2013

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. TRUST RESTAMINE doxylamine succinate 25mg tablet blister pack

Product Type

Single Medicine Product

Effective date

24/08/2017

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For temporary relief of sleeplessness

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PE/PVDC/Al

24 Months

Store below 30

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S3) Pharmacist Only Medicine

Components

1.

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

White to off white circular biconvex uncoated tablets, breakline on one side

and plain on the other

Active Ingredients

doxylamine succinate

25 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 28.11.2017 at 12:06:41 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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Therapeutic Goods Administration - Australia