Medicine labels and allergies


The TGA has issued a reminder about the transition to new medicine labels and listings for allergens

While new labels have started to appear on medicines, manufacturers have been given four years to fully redesign their labels and transition to the new ones.

“It can sometimes be difficult to tell whether a medicine label is following the old rules or the new rules,” warns the TGA.

It advises consumers to ask pharmacists and other healthcare practitioners about the allergen content in medicines.

Under the new rules for prescription medicines, allergen information must appear on either the label on the pack or in the CMI leaflet. If it is in the leaflet, there will be a prompt on the pack conveying this.

For most OTC medicines, the new rules mean there will be a table of critical health information on the back or side of the medicine pack, with information about potential allergens listed under the ‘Warnings’ heading. This will always appear after information about the uses for the medicine. There may also be an ‘allergy’ subheading under warnings.

Information about the allergen contents of a medicine can be found in the CMI, PI, through the medicine sponsor or distributor, or via the TGA.

Potential allergens that must now be declared on both OTC and prescription medicines include:

  • Antibiotics (Residue; all routes of administration)
  • Aspartame (Oral only)
  • Benzoates (E.g. benzoic acid, sodium benzoate; all routes of administration)
  • Crustacea and crustacean products (All routes of administration)
  • Egg and egg products (All routes of administration)
  • Ethanol (If concentration is 3% v/v or more; all routes of administration)
  • Fish and fish products (All routes of administration)
  • Galactose (Oral only)
  • Gluten (Only required to be declared where concentration is 20 ppm or more, same as with food in Australia; all routes of administration except for skin and mucous membrane applications)
  • Hydroxybenzoic acid esters (All routes of administration)
  • Lactose (Oral only)
  • Milk and milk products (If lactose is the only milk product, the label will only need to have the ‘contains lactose’ declaration; all routes of administration)
  • Peanut and peanut products (E.g. Arachis hypogea and peanut oil; all routes of administration)
  • Phenylalanine (All routes except for skin and mucous membrane applications)
  • Pollen (Oral only)
  • Potassium salts (E.g. potassium bicarbonate and potassium chloride; oral only)
  • Propolis (Oral only)
  • Royal jelly (Oral only)
  • Saccharin (Oral only)
  • Sesame seeds and sesame seed products (All routes of administration)
  • Sodium salts (E.g. Sodium bicarbonate and sodium chloride; oral only)
  • Soya and soya bean products (E.g. Glycine max, soya bean soya oil; does not include fully refined soya oil, vitamin e from soya bean sources, phytosterols from soya bean sources, and plant stanol esters from soya bean sources; all routes of administration)
  • Sorbates (E.g. potassium sorbate and sorbic acid; all routes of administration)
  • Sucralose (Oral only)
  • Sugar alcohols (E.g. erythritol, isomalt, lactitol, maltitol, mannitol, polydextrose, sorbitol and xylitol; oral only)
  • Sugars – monosaccharides and disaccharides (Oral only)
  • Sulfites (E.g. potassium metabisulfite, sulphur dioxide; if a medicine may contain sulphur dioxide as a residue, e.g. gelatin, it must be identified on the label; all routes of administration).
  • Tartrazine (All routes of administration)
  • Tree nuts and tree nut products (E.g. Almond oil, macadamia nut oil, almond, Brazil, cashew, chestnut and walnut; does not include coconut; all routes of administration)

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