GAVISCON EXTRA STRENGTH peppermint oral liquid bottle

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

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Active ingredient:
calcium carbonate,potassium bicarbonate,sodium alginate
Available from:
Reckitt Benckiser Pty Ltd
Authorization status:
Registered
Authorization number:
346341

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Public Summary

Summary for ARTG Entry:

346341

GAVISCON DOUBLE STRENGTH peppermint oral liquid bottle

ARTG entry for

Medicine Registered

Sponsor

Reckitt Benckiser Pty Ltd

Postal Address

PO Box 20097 World Square, Sydney, NSW, 2002

Australia

ARTG Start Date

21/10/2020

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 . GAVISCON DOUBLE STRENGTH peppermint oral liquid bottle

Product Type

Single Medicine Product

Effective Date

21/10/2020

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

For the relief of the symptoms associated with reflux oesophagitis, hiatus hernia and all cases of epigastric distress where the underlying cause is

gastro-oesophageal reflux.

Warnings

No Warnings included on Record

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

2 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

500mL

Not scheduled. Not considered by committee

140mL

Not scheduled. Not considered by committee

Components

1 .

Dosage Form

Oral Liquid, suspension

Route of Administration

Oral

Visual Identification

Off-white suspension

Active Ingredients

calcium carbonate

20 mg/mL

potassium bicarbonate

20 mg/mL

Public Summary

Page 1 of

Produced at 12.01.2021 at 12:25:51 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

sodium alginate

100 mg/mL

Other Ingredients (Excipients)

carbomer 934P

Flavour

methyl hydroxybenzoate

propyl hydroxybenzoate

purified water

saccharin sodium

sodium hydroxide

© 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 12.01.2021 at 12:25:51 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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