PRO-MAX CAFFEINE CAPSULES 100mg soft capsule blister pack

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

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Active ingredient:
caffeine
Available from:
Nova Pharmaceuticals Australasia Pty Ltd
Authorization status:
Registered
Authorization number:
347010

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Public Summary

Summary for ARTG Entry:

347010

PRO-MAX CAFFEINE CAPSULES 100mg soft capsule blister pack

ARTG entry for

Medicine Registered

Sponsor

Nova Pharmaceuticals Australasia Pty Ltd

Postal Address

Suite 305 / 10 Norbrik Drive, BELLA VISTA, NSW, 2153

Australia

ARTG Start Date

2/11/2020

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 . PRO-MAX CAFFEINE CAPSULES 100mg soft capsule blister pack

Product Type

Single Medicine Product

Effective Date

2/11/2020

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

Relieves mental fatigue, drowsiness and general inertia

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 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Not scheduled. Not considered by committee

Components

1 .

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Orange colored, oval shaped capsules printed with "61" in black

Active Ingredients

caffeine

100 mg

Other Ingredients (Excipients)

ammonia

butan-1-ol

Public Summary

Page 1 of

Produced at 11.01.2021 at 11:37:57 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

citric acid

Gelatin

glycerol

industrial methylated spirit

iron oxide black

isopropyl alcohol

macrogol 400

partially dehydrated liquid sorbitol

PEG-40 hydrogenated castor oil

propylene glycol

purified water

Shellac

simethicone

strong ammonia solution

sulfuric acid

sunset yellow FCF

titanium dioxide

© 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 11:37:57 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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