PHENYLEPHRINE HCl NASAL DECONGESTANT phenylephrine hydrochloride 10mg tablet blister pack

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

Buy It Now

Active ingredient:
phenylephrine hydrochloride
Available from:
Neo Health (OTC) Pty Ltd
Authorization status:
Registered
Authorization number:
351924

Read the complete document

Public Summary

Summary for ARTG Entry:

351924

PHENYLEPHRINE HCl NASAL DECONGESTANT phenylephrine hydrochloride 10mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Neo Health (OTC) Pty Ltd

Postal Address

3/380 Pennant Hills Road, Pennant Hills, NSW, 2120

Australia

ARTG Start Date

18/12/2020

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 . PHENYLEPHRINE HCl NASAL DECONGESTANT phenylephrine hydrochloride 10mg tablet blister pack

Product Type

Single Medicine Product

Effective Date

18/12/2020

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

Temporary symptomatic relief from sinus and nasal congestion due to hay fever, seasonal and perennial allergic rhinitis, sinusitis, the common cold and flu.

Warnings

No Warnings included on Record

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

24 Months

Store below 30

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

(S2) Pharmacy Medicine

Not Scheduled after consideration by Committee

Not scheduled. Not considered by committee

Not scheduled. Not considered by committee

Not scheduled. Not considered by committee

Components

1 .

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Red coloured, round shape biconvex film-coated tablets plain on both sides.

Active Ingredients

Public Summary

Page 1 of

Produced at 11.01.2021 at 08:03:06 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

phenylephrine hydrochloride

10 mg

Other Ingredients (Excipients)

allura red AC

croscarmellose sodium

hypromellose

magnesium stearate

microcrystalline cellulose

povidone

purified talc

sunset yellow FCF aluminium lake

titanium dioxide

triacetin

© 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 11.01.2021 at 08:03:06 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

Similar products

Search alerts related to this product

Share this information