FAB IRON
Main information
- Trade name:
- FAB IRON + Vitamin B Complex
- Active ingredient:
- Ascorbic acid,Biotin,Calcium pantothenate,Cyanocobalamin,Iron amino acid chelate,Nicotinamide,pyridoxine hydrochloride,Riboflavin,Thiamine nitrate
- Available from:
- Care Pharmaceuticals Pty Ltd
- INN (International Name):
- Ascorbic acid,Biotin,Calcium pantothenate,Cyanocobalamin,Iron amino acid chelate,Nicotinamide,pyridoxine hydrochloride,Riboflavi
- Medicine domain:
- Humans
- Medicine type:
- Allopathic drug
Documents
- for the general public:
- Public Assessment Report
-
- for the general public:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
- for healthcare professionals:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for healthcare professionals.
Localization
- Available in:
-
Australia
- Language:
- English
Other information
Status
- Source:
- Dept. of Health,Therapeutic Goods Administration - Australia
- Authorization number:
- 219891
- Last update:
- 08-10-2017
Public Assessment Report
Public Summary
Summary for ARTG Entry:
219891
FAB IRON + Vitamin B Complex
ARTG entry for
Medicine Listed
Sponsor
Care Pharmaceuticals Pty Ltd
Postal Address
PO Box 1674,BONDI JUNCTION, NSW, 1355
Australia
ARTG Start Date
5/02/2014
Product category
Medicine
Status
Active
Approval area
Listed Medicines
Conditions
Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Act, shall be only those included in
the list of 'Colourings permitted in medicines for oral use'.
The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine,
(b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is
sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be
kept.
The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records
to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request.
The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted
in relation to the inclusion of the medicine in the Register.
All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Office
of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors
of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notified
of the report or reports.
The sponsor shall not supply the listed medicine after the expiry date of the goods.
Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine
outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National
Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor.
Products
1. FAB IRON + Vitamin B Complex
Product Type
Single Medicine Product
Effective date
5/02/2014
Warnings
Not for the treatment of iron deficiency conditions (or words to that effect).
Vitamins can only be of assistance if the dietary vitamin intake is inadequate. OR Vitamin supplements should not replace a balanced diet.
Standard Indications
For vitamin (may state the vitamin) supplementation.
Source of iron. Can assist in maintaining normal blood.
May assist in the management of dietary iron deficiency.
Source of iron. Iron is necessary for the formation of haemoglobin which transports oxygen to the tissues.
Source of iron. Can assist in maintaining normal blood. Blood tonic.
Specific Indications
Helps restore energy and vitality. A combination of easy to absorb iron, energy boosting B group vitamins and zinc to help restore and support your
immune system.
Iron out that tired feeling.
Easy to absorb. Contains Vitamin C to assist with maximum iron absorption.
Easy to digest. Contains an organic chelated form of iron that is easy to absorb and digest in the body.
Gentle on the stomach. Chelated iron is well tolerated and gentle on the stomach.
Iron is a mineral essential for everyday life. It is used by the body to transport oxygen, maintain healthy blood levels and release energy. Low iron levels
can result in tiredness and lack of energy.
Suitable for women, teenage girls and vegetarians.
Additional Product information
Container information
Type
Material
Life Time
Temperature
Closure
Conditions
Bottle
Not recorded
Not recorded
Not recorded
Child resistant closure
Not recorded
Pack Size/Poison information
Public Summary
Page 1 of
Produced at 22.11.2017 at 11:34:34 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
Pack Size
Poison Schedule
Components
1. Formulation 1
Dosage Form
Tablet, film coated
Route of Administration
Oral
Visual Identification
Active Ingredients
Ascorbic acid
75 mg
Biotin
50 microgram
Calcium pantothenate
5 mg
Cyanocobalamin
10 microgram
Iron amino acid chelate
50 mg
Nicotinamide
15 mg
pyridoxine hydrochloride
4 mg
Riboflavin
10 mg
Thiamine nitrate
10 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 2 of
Produced at 22.11.2017 at 11:34:34 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
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
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