Australian Approved Name (AAN): Shark-liver oil
Mandatory components: Vitamin A and Colecalciferol
Maximum daily dose: When for internal use the MRDD must be no more than 3000µg RE of Vitamin A and 25µg of Vitamin D. When for topical use the concentration of Vitamin A in the medicine must be no more than 1%.
Warnings and restrictions: When divided preparations for internal use in adults contain more than 33µg of Retinol Equivalents per dosage unit the medicine requires the following warnings on the label:
VITA2 – WARNING: If you are pregnant – or considering becoming pregnant – do not take vitamin A supplements without consulting your doctor or pharmacist [or words to that effect]. NOTE: Position this warning at the beginning of the directions for use.
VITA4 – WARNING: When taken in excess of 3000micrograms retinol equivalents – vitamin A can cause birth defects. NOTE: Position this warning at the beginning of the directions for use.
VITA3 – The recommended daily amount of vitamin A from all sources is 700micrograms retinol equivalents for women and 900micrograms retinol equivalents for men.
When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label:
VIT – Vitamins can only be of assistance if the dietary vitamin intake is inadequate. or Vitamin supplements should not replace a balanced diet.
SFOOD- Derived from seafood (fish; or contains fish products)
Allowable purpose of the ingredient: Active. Excipient
TGA reference: OECD Multilingual Dictionary of Fish and Fish Products (modified); OECD. Multilingual Dictionary of Fish and Fish Products