Allergies and medicines

12 May 2017

Some medicines may contain substances that might cause an allergic reaction in some people. Unlike foods, most medicines are not required to list all the ingredients that are included in the medicine on the label. The active ingredient will always be on the medicine label, but only some inactive ingredients, also called excipients, must be on the label. Also, some potential allergens, such as impurities from manufacturing, may not be on the label.

Medicine labels are being improved to make it easier for you to find important information. These changes will mean that over time more medicines will be labelled with information on allergens. You can search the list below for potential allergens that must be declared.

Better Medicine Labels

New labels are starting to appear on medicines. However, it will be a number of years before all medicine labels meet new requirements. Medicine companies have been given four years to redesign their labels to meet the new rules and use up stock with old labels. It can sometimes be difficult to tell whether a medicine label is following the old rules or the new rules. Therefore, during this transition, it is important to keep asking your doctor, pharmacist or other health professional about food allergen content in medications.

What is new on medicine labels?

Some ingredients that may be allergens, such as peanuts and gluten, must already be declared on medicine labels. Under the new rules, there will be a longer list of substances that must be declared on a label if they are present in the medicine. The additional substances include crustacea, fish, eggs, soya, milk and tree nuts. However, you may have allergies to substances which do not have to be on medicines labels under Australian law.

If you are allergic to a substance, and want to know if it must be declared on a medicine label, you can search the list below for potential allergens that must be declared.

For many years the list only applied to medicines purchased from pharmacies, supermarkets and health-food shops. Until now, prescription medicines did not need to declare this allergen information on the label. Under the new rules, prescription medicine labels will have either a declaration about the allergen or a statement directing you to the Consumer Medicines Information leaflet.

Where can I find allergen information on the label

Medicine companies have been given four years to redesign their labels to meet the new rules and use up stock with old labels. It can sometimes be difficult to tell whether a medicine label is following the old rules or the new rules. Therefore, during this transition, it is very important to keep asking your doctor, pharmacist or other health professional about food allergen content in medications.

You will usually see the allergen declared on the label as "contains (substance name)".

illustration of a prescription medicine label

Prescription medicines

Under the new rules for prescription medicines, allergen information must appear on either the label on the pack or in the Consumer Medicine Information leaflet. If it is in the leaflet, there will be a prompt on the pack telling you this. There is no specific place on the medicine pack that this allergen information or statement must appear.

illustration of an over the counter medicine label

Over-the-counter medicines

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

illustration of a complementary medicine label

Listed medicines (includes most complementary medicines)

There is no specific place on listed medicine packs where allergen information must appear, however it is usually on the back or side label.

I can't find what I'm looking for!

In the first instance, you should talk to your doctor, pharmacist or health practitioner if you have any concerns about the contents of your medicine.

There are also other ways to find information about the contents of a medicine:

  • Many medicines have a Consumer Medicines Information leaflet (CMI). You can search for the CMI on the TGA website.
  • If your medicine has been prescribed to you, your doctor or pharmacist might also look in the Product Information (PI) which can be found on the TGA website for prescription medicines.
  • You can contact the medicine sponsor or distributor. Their contact details must always be on the medicine label.
  • Contact the TGA to ask if a particular substance is an ingredient in a medicine. You will need to tell us the name of the substance (or substances) you want to know about, the name of the medicine and the AUST L or AUST R number.
  • We hold information about medicine ingredients, but not manufacturing impurities or contaminants.

Search the list

The following is a list of substances that must be declared on labels and includes potential allergens.

Rules about how and what substances are declared

This is a list of all the substances that are required under new labelling rules to be declared on medicine labels. Many of these substances are included because they are allergens.

There are rules about when substances need to be declared on medicine labels. For example:

  • some substances don’t have to be declared if the medicine is only for topical use
  • some substances are only declared if there is a certain amount in the medicine

Substances that were not previously required to be declared on medicine labels are shown in the table below as a "new substance".

Start typing what you are looking for into the filter field below. To reset the filter, simply delete your search terms from the filter field.

Ingredient* New substance Route of administration Label statement Other information
antibiotics Yes All "contains residual 'antibiotic name'" This declaration is only required when the antibiotic is not an active ingredient and is only a residue.
aspartame No Oral only "contains aspartame"  
benzoates No All "contains benzoates" Examples include benzoic acid and sodium benzoate.
crustacea and crustacean products Yes All "contains crustacea" or "contains crustacean products" Examples include crab, crayfish, lobster, prawn and shrimp.
egg and egg products Yes All "contains egg", or "contains egg products", or "manufactured in eggs" Examples include dried egg yolk, egg lecithin and the influenza vaccine.
ethanol No All "contains alcohol" If the concentration is 3% v/v or more, the quantity of ethanol as %v/v will be declared on the label.
fish and fish products Yes All "contains fish", or "contains fish products" Examples include freshwater fish, diadromous fish and marine fish, including cod, cod – liver oil, halibut, shark and tuna.
galactose No Oral only "contains galactose"  
gluten No All, except for skin and mucous membrane applications. "contains gluten"

Includes gluten that is present naturally as a part of an ingredient such as wheat starch.

Gluten is only required to be declared on the label where it the concentration in the medicine is 20 parts per million or more. This is the same rule that applies to food in Australia.

hydroxybenzoic acid esters No All "contains hydroxybenzoates" Examples include ethyl hydroxybenzoate, methyl hydroxybenzoate, propyl hydroxybenzoate, sodium ethyl hydroxybenzoate, sodium methyl hydroxybenzoate and sodium propyl hydroxybenzoate .
lactose No Oral only "contains lactose" If the lactose is derived from milk, the label will not need to have the "contains milk products" declaration.
milk and milk products Yes All "contains milk", or "contains milk products"

Examples include casein, hydrolysed milk protein, non-fat dry milk, whey powder and whole dry milk.

If lactose is the only milk product that the medicine contains, the label will only need to have the "contains lactose" declaration.

peanut and peanut products No All "contains peanuts", or "contains peanut products" Examples include Arachis hypogea and arachis (peanut) oil.
phenylalanine No All, except for skin and mucous membrane applications. "contains phenylalanine"  
pollen No Oral only "contains pollen"  
potassium salts Yes Oral only

If the total maximum daily dose of the medicine contains more than 39mg, the label must declare the amount of potassium in each tablet, capsule or in a stated amount of a solid or liquid.

"contains XX mg of potassium per dose"*
* dose may be the dosage unit such as a tablet or capsule, or it may be a stated amount of liquid or solid e.g. "contains XX mg of potassium per 1mL"

Examples include potassium bicarbonate and potassium chloride.
propolis No Oral only "contains propolis"  
royal jelly No Oral only "contains royal jelly"  
saccharin No Oral only "contains saccharin" Examples include saccharin calcium and saccharin sodium.
sesame seeds and sesame seed products Yes All "contains sesame seed", or "contains sesame seed products" Examples include Sesamum indicum, sesame seed and sesame oil.
sodium salts No Oral only

If the total maximum daily dose of the medicine contains more than 120mg, the label must declare the amount of sodium in each tablet, capsule or in a stated amount of a solid or liquid.

"contains XX mg of sodium per dose"*
* dose may be the dosage unit such as a tablet or capsule, or it may be a stated amount of liquid or solid e.g. "contains XX mg of sodium per 1mL"

Examples include sodium bicarbonate and sodium chloride.
soya and soya bean products Yes All "contains soya bean", or "contains soya bean products"

Examples include Glycine max, soya bean soya oil.

Does not include fully refined soya oil, vitamin e (such as d-alpha tocopherol) from soya bean sources, phytosterols from soya bean sources and plant stanol esters from soya bean sources.

sorbates No All "contains sorbates" Examples include potassium sorbate and sorbic acid.
sucralose Yes Oral only "contains sucralose"  
sugar alcohols No Oral only

"contains sugar alcohols" or "contains name of sugar alcohol"

If the total maximum daily dose of the medicine contains more than 2g, the label must declare the amount of sugar alcohols present per recommended maximum daily dose; and a statement "Products containing (name of sugar alcohol) may have a laxative effect or cause diarrhoea"

Examples include erythritol, isomalt, lactitol, maltitol, mannitol, polydextrose, sorbitol and xylitol.

sugars - monosaccharides and disaccharides No Oral only If the total maximum daily dose of the medicine contains more than 100mg of sugar, resulting in a significant glycaemic effect, the label must declare sugar as "contains sugars"

Examples include fructose, glucose, honey, invert sugar, lactose, maltose and sucrose.

sulfites No All "contains sulfites"

Examples include potassium metabisulfite, sodium bisulfite, sodium metabisulfite, sodium sulphite and sulphur dioxide.

If a medicine may contains sulfur dioxide as a residue, for example, gelatin, it must be identified on the label.

tartrazine No All "contains tartrazine"  
tree nuts and tree nut products Yes All "contains tree nuts", or "contains tree nut products"

Examples include: Juglans nigra, Macadamia ternifolia, Prunis dulcis, almond oil, macadamia nut oil almond, Brazil, cashew, chestnut and walnut.

Tree nuts are the seeds of a variety of trees and shrubs which are characterised by a hard inedible shell enclosing an oily seed. Coconut is the fruit of the palm (Cocos nucifera) and is not considered to be a tree nut.

* This list comes from Schedule 1 to Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines and Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines.