Labelling a supplement in Australia: what TGO 116 requires

The main label

The main label is "the label, or part of the label, that is most likely to be displayed, presented, shown, or examined under ordinary or customary conditions of display". On the primary pack and the container it must show:

• the name of the medicine;
• the name of each active ingredient;
• the quantity or proportion of each active ingredient;
• the name of the dosage form; and
• the quantity of the medicine in the container or pack.

The name, the active ingredients and their quantities form a "cohesive unit": the actives and their quantities sit together on separate lines immediately below the name (or beside it, if that would disrupt or obscure the trade mark), not separated by other text or graphics except as the order allows. Everything the main label must carry runs in the same direction.

Two allowances suit supplements. A listed medicine with two or more active ingredients (other than a sunscreen) may show them on another part of the label instead, with the same cohesive-unit rules, except that the block needn't include the name or sit on the main label. And a listed medicine's main label may drop the salt, hydrate or solvate from an active's name if the full Australian Approved Name appears elsewhere on the label, the strength isn't based on the salt, hydrate or solvate, and it doesn't matter to safety or efficacy.

The AUST L number comes from the Therapeutic Goods Regulations rather than TGO 116, as a note to the order explains: it goes on the main label, or on a securely fixed sticker beside it, in characters at least 1 mm high. More on the number in our ARTG guide.

Everything else the label must show

The label on the container and on the primary pack must also include:

Information	What TGO 116 says
Batch number	With the batch number identifier
Expiry date	With the expiry date identifier
Storage conditions	For the medicine
The sponsor	Its name and contact details: an Australian phone number or a current email address, or a website that gives one; an address, if given, is the principal place of business in Australia, not a post office (such as a PO box) or other code address
Declared substances	Each Schedule 1 substance the medicine contains, for the routes and thresholds Schedule 1 sets, under the name it gives and with any statement it requires: allergens such as peanuts, tree nuts, milk, egg, fish, crustacea, molluscs, sesame, soya and wheat, and others such as lactose, sugars, sulfites, aspartame, alcohol (with its percentage), propolis and royal jelly
Warning statements	Those that apply to the medicine (below), immediately below the heading "Warnings" or straight after the prefix "Warnings"
Directions for use	On the label, unless there isn't enough space, in which case they can go on the package or in a package insert, with the label saying where
The indications	What the medicine is for

Some ingredients bring their own lines. Gluten, or an ingredient from a gluten-containing grain at 20 ppm or more, is declared as "gluten". An oral medicine whose sugar alcohols total more than 2 g in the maximum recommended daily dose must state that quantity and, unless the sugar alcohol is glycerol, carry "Products containing [name of sugar alcohol] may have a laxative effect or cause diarrhoea", worth checking on a sugar-free gummy. An oral mineral supplement may show the name and quantity of the element it supplies alongside the name and quantity of the active ingredient.

Text size, contrast and small packs

Everything the order requires must be in English, clearly legible, durable, in text at least 1.5 mm high unless the order or the Regulations say otherwise, and in a colour that contrasts strongly with the background (an embossed batch number or expiry date is exempt from the colour rule). The larger sizes for active ingredients, and the critical health information panel, apply to registered medicines, not listed ones.

• Small containers. A container of 25 mL or less inside a primary pack. Its label must carry, in text at least 1.5 mm high, the name of a listed medicine, the name and quantity of each active, the dosage form, the quantity, the batch number, the expiry date and the sponsor's name as on the primary pack, or a registered trade mark that readily identifies the sponsor.
• Blister and strip packs. They carry the name, the actives and their quantities, the batch, the expiry and the sponsor (or a registered trade mark that readily identifies it). A listed medicine with two or more actives can leave the actives off. Where segments tear off, at least every second segment carries the name, plus the active and its quantity if there is only one active.
• Many actives, little space. Where a listed medicine's actives sit off the main label and it is in a small or medium container, or has 10 or more actives and too little space, they needn't go on separate lines, but their names must be in bold.

Large tablets and capsules

A capsule more than 24.1 mm long or 9.5 mm wide, a round tablet more than 13 mm across, or a non-round tablet more than 22.4 mm long or 10.5 mm wide is a large dosage form. Its directions must include "Swallow with water" or words to that effect. A transparent pack or a medium container instead carries "Warning: large [name of dosage form]. Swallow with water". Other packs also need, on the main label or a lid sticker, an image of the tablet or capsule at actual size, with "actual size" and "Warning: large [name of dosage form]" right beside it. None of this applies if the primary pack is a small container, or if the medicine isn't meant to be swallowed whole, such as a chewable, and its directions say how to take it. It is worth checking before the artwork is locked: a large softgel changes the main label.

Where the warnings come from

TGO 116's "warning statements" gather the statements from several places: any standard that applies to the medicine, those required as a condition of listing, the current Poisons Standard, the instruments that set requirements for ingredients, the statements required for an indication shown on the label, and the advisory statements specified for medicines under the Act.

Many come from the Therapeutic Goods (Medicines Advisory Statements) Specification 2021, in force since 1 January 2022, whose schedule is the Required Advisory Statements for Medicine Labels (RASML No. 6). It ties each statement to an ingredient, in the circumstances it sets, and the wording can be varied only "in a manner that does not change the intent". Folic acid in a preparation indicated for reducing the risk of having a child with spina bifida or a neural tube defect, for example, carries "Do not exceed the stated dose except on medical advice." and "If you have had a baby with a neural tube defect/spina bifida, seek specific medical advice."

The TGA consulted on changes for a RASML No. 7 from 27 July to 4 September 2026; until a new instrument is made, No. 6 applies. A medicine for oral use with an active ingredient in category B1, B2, B3 or C of the TGA's Prescribing medicines in pregnancy database, and no other pregnancy warning, carries "If pregnant or likely to become pregnant, consult a pharmacist or a doctor before use" or words to that effect.

What a label can't say

• Beyond the ARTG. The TGA counts it as unacceptable presentation where "statements or pictures suggest that the product has uses or actions different from, or in addition to, the indications for use included in the ARTG", and a listed medicine with unacceptable presentation can be cancelled from the ARTG.
• Advertising rules apply. The label must comply with all relevant legislation, the TGA says, "including advertising requirements": more in our advertising guide.
• Websites and QR codes. A website on a label is acceptable only where its information is consistent with the ARTG entry. A QR code must link to information the sponsor controls, or the TGA's information about the medicine; it must not contradict the label or the medicine's product details, must not ask for a login, personal details or a payment, and can't replace anything the label must carry unless the order allows it.
• "TGA assessed". Only an assessed listed medicine, or a registered complementary medicine whose efficacy the TGA assessed before market, can carry it: see our assessed listed medicines guide.

The packaging rules beside TGO 116

• Child-resistant packaging. TGO 95 requires it for listed and registered medicines containing certain substances in set strengths or pack sizes, and for any medicine whose label or pack says or implies it is child-resistant. Iron is on the list: a pack with more than 250 mg of elemental iron in total, unless each dose unit has 5 mg or less and the iron is combined with other actives. TGO 95 is due to sunset on 1 April 2028.
• Tamper evidence. The TGA's code of practice for tamper-evident packaging isn't mandatory, but some industry associations make it a condition of membership, and goods sold in tamper-evident packaging must say so on the pack.

The transition

TGO 116 commenced in full on 30 September 2026. A medicine released for supply before 1 October 2031 may follow TGO 92 instead, or TGO 92 with the TGO 116 provisions listed in the order's table in place of their TGO 92 equivalents. From 1 October 2031, every medicine released for supply follows TGO 116 in full. The test is the date of release for supply, not the date of sale.

So a label in use today can stay as it is for now, and a new label is best written to TGO 116 from the start, to save a second round of artwork before 2031. The TGA's guidance for the TGO 92 route is "Labelling medicines to comply with TGO 91 and TGO 92" (version 2.5, December 2024), and it said in August 2026 that it would publish guidance for each new order "as soon as practicable after registration".

Where we come in

We draft and review the label with the listing, from the design brief to print-ready artwork, checking every claim, ingredient and mandatory statement against the labelling order that applies. On Arxi's prenatal chewable, our label review caught two errors before print; for The Belly Solution we drafted and reviewed the label of a travel gut-health powder; for Your Skin Scan, label compliance came with the listing. More on packaging and labelling, or book a call.