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Medicine labels: Guidance on TGO 91 and TGO 92

Version 2.1, July 2019

15 July 2019

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4. Tabulated display of CHI

Certain registered non-prescription medicines must comply with the requirements of subsection 8(2) of TGO 92. This prescribes the presentation of tabulated Critical Health Information (CHI) for these medicines. To allow sponsors some flexibility in design, not all aspects of its presentation are subject to mandatory requirements.

However, it is important that all aspects are considered when designing the label, and therefore both mandatory requirements and best practice guidance have been co-located in this section for ease of reference.

Mandatory requirements are described using must.

4.1 Critical Health Information - CHI

Critical health information (CHI) is information that is important for the safe use of non-prescription medicines. It should be easy for consumers to find and understand this information when they read a medicine label.

4.1.1 What information does it cover?

Section 6 of TGO 92 defines which of the information required under subsection 8(1) is considered CHI.

CHI comprises:

  • the names of all active ingredients in the medicine
  • the quantity or proportion of all active ingredients in the medicine
  • intended purpose of the medicine
  • relevant warning statements
  • substances required to be declared on a label and any associated statements (Schedule 1 to the Orders)
  • directions for use.
'Other information'

To provide flexibility in designing the table of CHI and the label, some 'other information' can be included in the table. This information is not mandatory to include in the tabulated format.

Paragraph 8(2)(e) of TGO 92 details the 'other information' that is not 'critical health information' but may be of importance to some consumers. This information should also be easy to locate and understand. This 'other information' comprises:

  • storage conditions (such as safe storage advice e.g. keep out of reach of children or mandatory temperature information e.g. store below 25°C)
  • any tamper evident features of the pack/container
  • sponsor or distributor contact details
  • a full list of the medicine's ingredients.

If you choose to include a full list of ingredients under this heading, any substances required to be declared under Schedule 1 must still appear under the 'Warnings' heading.

If you decide not to include the 'other information' heading in the table of CHI, you must include any mandatory information, such as storage conditions, elsewhere on the label.

4.1.2 Display of CHI - Mandatory requirements

You must include the critical health information (CHI) in a consistent location and format on the labels of most registered non-prescription medicines.

Subsection 8(2) of TGO 92 specifies certain requirements for displaying CHI.

You must display CHI in a tabulated format and the information must:

  • be under relevant headings
  • be in a particular order
  • have a white or other contrasting background
  • be in only one colour (both text and associated punctuation)
  • be black or another dark colour

The table containing CHI must not:

  • contain any additional information, other than that specified
  • use fonts, bolding or colours to highlight parts of the CHI (except for headings/subheadings or when it is mandatory)
  • contain logos or graphics that break up or interfere with the CHI
  • include marketing information, such as 'free from' claims

There are only a few mandatory formatting requirements for the tabulated display of CHI. You have flexibility to design a format that suits medicines supplied in different types of packs and pack sizes and use colour palettes that are consistent with branding or have been developed as part of user-testing performed during product development.

Medicines not required to use tabulated CHI display

Medicines that are exempt from using the tabulated CHI display on their labels are specified in subsection 8(3) of TGO 92.

Options within tabulated CHI display

You have the option to include some additional information within the tabulated display of CHI.

Paragraphs 8(2)(d) and (e) of TGO 92 specify types of information that are not required by the Order but can be included in the table.

These are:

  • Words describing the pharmacological category or principal intended actions of the active ingredient(s)
  • Safety related information such as:
    • allergen advice
    • advice about keeping the medicine out of reach of children
    • non-mandatory cautions or warnings
Headings

You must present the CHI under appropriate headings.

You can choose the words to use in each heading, however they must have the same meaning as the headings described in paragraph 8(2)(b) of TGO 92.

Headings should be of sufficient prominence to distinguish them from the critical health information text. Headings do not have the same formatting requirements as the CHI but must contrast strongly with the background. You can use bolding, different coloured background or text to present the headings).

Order of CHI

You must display the CHI headings in the following order (specified in subsection 8(2) of TGO 92):

  • Name and quantity of the active ingredient(s)
  • Indications
  • Warnings
  • Directions for use
  • Other information (this section of the CHI is optional).
Warnings

You must include all mandated warnings and advisory statements that apply to your medicine under this heading in the CHI tabulated display. This includes declarations of substances identified in Schedule 1 to TGO 92.

If you must include multiple statements, these can be grouped under sub-headings to improve readability.

Advisory statements such as 'drink plenty of water' can be included under this heading.

Schedule 1 declarations, such as declaration of allergens, must be included under the warnings heading, even if the ingredient appears in a full list of ingredients elsewhere in the table.

Signal headings required by the Poisons Standard do not need to be included in the table.

Directions for use

Directions for use are critical to ensure the safe use of medicines for different target populations using the same medicine, or people using the same medicine for different purposes.

Directions for use must include information on:

  • appropriate doses of the medicine
  • the method of administration or use of the medicine
  • the frequency and duration of treatment for each statement of purpose or indication for the medicine
  • the use of the medicine by people of particular ages or those with particular medical conditions.

If required, the approved dosage directions must include additional information such as the maximum daily dose for each age group or frequency and duration for each target population to ensure safe use of your medicine.

Warnings specifically about the directions for use, such as the duration of use or patient age, may appear under this heading.

Dosing for liquid, solid or semi-solid medicines

You:

  • must label the dose of your medicine in metric units (e.g. 5 mL, 10 g).
  • must state the equivalent metric units if your dosage instructions use a calibrated or standardised measuring implement that is included with your medicine.
  • must not state the dosage in terms of culinary spoonsful (e.g. teaspoon, tablespoon, etc.); these spoons are not standardised or calibrated.
Lengthy directions

If you cannot fit your directions for use into the display of CHI, you must include these on a package insert.

Consistent with section 8 of TGO 92, if you do this, you must include a statement under the 'directions for use' heading that refers consumers to the package insert, e.g. 'please refer to package insert for instructions on how to use this medicine' or words to that effect.

4.1.3 Different ways to name active ingredients on the main label

If your medicine label includes CHI in the tabulated display, you are not required to use the full Australian Approved Name (AAN) to identify the active ingredients on the main label. You may choose to use an abbreviated name instead.

Many approved names are lengthy because they include chemical components (such as waters of hydration or salts) in addition to the therapeutically relevant moiety. To assist readability for consumers, this additional scientific information can be omitted from the main label of your medicine if the full approved name is displayed as CHI.

You can only use the active moiety in place of the full approved name if the moiety is part of the approved name.

Therefore, this approach is associated with chemical ingredients that use an 'Australian Approved Name', and is not relevant to complex complementary medicine substances.

For example, if your medicine contains 'oxymetazoline hydrochloride' as an active ingredient, the main label could state 'oxymetazoline' immediately under or next to the medicine name. If you choose to do this, you must not include any quantity information with the abbreviated name on the main label (full AAN and the quantity will need be included in the table of CHI).

If your medicine contains more than one active ingredient and one of those is identified using the active moiety without quantity information, you must not include quantity information for any of the active ingredients on the main label.

4.1.4 Display of CHI - Best practice

If your medicine is in a container that is supplied in an outer pack (i.e. primary pack) that meets the requirements of subsection 8(2), you do not have to duplicate the CHI tabulated display on the container label (inner label).

  • Where space permits we recommend also using the specified CHI presentation on the container label.
  • Where there is insufficient space on the container label and the information cannot be presented in a tabulated form, we recommend that you present the information in the same order as in the CHI on the primary pack.
Simple language

We recommend wording your CHI succinctly and in plain English wherever specific wording is not mandated.

Title

We recommend using the heading Medicine information (in larger text) for the table containing the CHI.

Border

We recommend techniques to highlight the information and improve readability such as:

  • box-borders (if space permits)
  • colour shades in or around the table.
Headings

We recommend that you highlight your headings using techniques such as:

  • bold fonts ( appropriate size)
  • shading
  • shaded coloured bars or text boxes across the width of the panel
  • different colours on a strongly contrasting background
  • bullet points (in the same colour as the heading text)
  • Do not use narrow letters or narrow word spacing
  • Do not use multiple colours or colours that are dark as the back ground for the CHI panel
  • Do not use white text on dark coloured background for the CHI (except for the headings/subheadings).
Use of sentences and capital letters

We recommend using sentences to present the CHI. Use a mix of upper and lower-case letters, starting sentences with a capital letter.

Do not use all-capital text. A mix of upper and lowercase characters is easier to read.

The exception is when capital letters are mandated by other regulatory requirements, such as RASML.

Active ingredient purpose

The pharmacological category or principal intended action of the active ingredients (the active ingredient purpose, e.g. 'antihistamine' or 'analgesic') can be included in the table of CHI. This is not to be confused with the medicine purpose or indications.

Grouping warnings

We strongly recommend you group warnings under subheadings such as:

  • 'Do not use if'
  • 'Ask a doctor or pharmacist before use if you'
  • 'Stop use and ask a doctor if'.
Text and font for warnings

For subheadings under the Warnings section, we recommend using bold font and text size that is not bigger than the heading.

You can present the subheading and warning as a continuous sentence (instead of a bullet) with the subheading in bold font when there is only one warning under a subheading. For example, 'Do not use if you are pregnant'.

RASML requirements

Make sure the meaning of the RASML warning does not change when you group warnings under a subheading.

You may need to make minor changes to either the subheadings or the warning statements to comply with RASML.

Directions for use

We recommend:

  • Using the 'Directions for use' section for advisories about dose or directions for use.
Specifying age groups

You can express the directions for use as a sentence unless there are different dosages for different age groups.

You should use a table format when there are more than two dosages or age groups recommended for your medicine.

If your medicine is not for use in children, we recommend that you:

  • specify that the dose is an adult dose (e.g. 'Adult dose: 10 mL')
  • include the statement 'For adults only' or words appropriate for your medicine.
Directions for symptomatic relief

Include the following qualifiers if the medicine is for symptomatic relief (e.g. cough and cold preparations) and does not require a course of treatment:

  • 'when necessary'
  • 'as required'
Continuation of CHI presentation

The CHI presentation should be a single panel in one field of view.

If this is not possible because of the packaging (e.g. smaller packs, cartons for tube presentations), you can use more than one table, column or panel for the required information but you must retain the order of information required by TGO 92.

We recommend:

  • Highlighting the table on each panel with techniques such as boxed borders or shading.
  • Placing the word 'continued...' at the right bottom corner of the first panel.
  • Titling the subsequent tables 'Medicine Information (continued)'

If you use more than one panel, we recommend using arrow heads (▷ or ◁) at the end of 'continued...' to mark the direction of the continuation.

4.2 Examples of CHI presentation

The following examples, using common OTC active ingredients, are intended to show how the CHI tables can be set out. Different presentations include:

  • Absence or use of borders
  • use of coloured backgrounds
  • use of coloured texts for headings
  • continuation of CHI when more than one table is required

The 'indications' under the 'Uses' heading in some examples below are only intended to show how they can be organised. Of course, indications included under this section on your medicine must be consistent with the ARTG entry.

The examples below only include the mandatory statements required for each relevant active ingredient at the time of preparing this guidance document. The CHI tables are permitted to include warning/advisory statements that are not mandated in RASML. In some instances the TGA may request the inclusion of additional warning/advisory statements. As warning/advisory statements and scheduling status of medicines change regularly, you must consult the latest publications to ensure that your medicines labels meet all applicable regulatory requirements.

Paracetamol tablets (showing the optional 'Purpose' of the active ingredient):

Screenshot of Paracetamol tablets example

Paracetamol and phenylephrine hydrochloride combination (showing the optional 'purpose' of the active ingredients):

Screenshot of paracetamol and phenylephrine hydrochloride combination example

Hydrocortisone and clotrimazole cream (the CHI table is continued on the other panels of the carton and the CHI table is without the optional Other Information section):

Screenshot of hydrocortisone and clotrimazole cream example

Paracetamol, phenylephrine and diphenhydramine combination (showing the optional 'purpose of the active ingredients'):

Screenshot of Paracetamol, phenylephrine and diphenhydramine combination (showing the optional 'purpose of the active ingredients') example

Ibuprofen for oral use:

Screenshot of Ibuprofen for oral use example

Ibuprofen and paracetamol combinations:

Screenshot of Ibuprofen and paracetamol combinations example

Aspirin for pain relief:

Screenshot of Aspirin for pain relief example

Aspirin for prevention of cardiovascular disease or inhibition of platelet aggregation:

Screenshot of aspirin for prevention of cardiovascular disease or inhibition of platelet aggregation example

Diclofenac (oral):

Screenshot of diclofenac (oral) example

Diclofenac (dermal):

Screenshot of diclofenac (dermal) example

Doxylamine combined with paracetamol and phenylephrine hydrochloride:

Screenshot of doxylamine combined with paracetamol and phenylephrine hydrochloride example

Antihistamines (such as diphenhydramine hydrochloride, promethazine hydrochloride and doxylamine succinate) as a sleep aid:

Screenshot of Antihistamines (such as diphenhydramine hydrochloride, promethazine hydrochloride and doxylamine succinate) as a sleep aid

Loperamide hydrochloride:

Screenshot of Loperamide hydrochloride

Naproxen/Naproxen sodium:

Screenshot of Naproxen/Naproxen sodium

Phenylephrine/pseudoephedrine for oral use:

Screenshot of phenylephrine/pseudoephedrine for oral user

Topical nasal decongestant preparations such as those containing the following active ingredients:

  • Naphazoline
  • Oxymetazoline
  • Phenylephrine
  • Xylometazoline.

Screenshot of topical nasal decongestant preparations

Vasoconstrictor eye drops including

  • Naphazoline
  • Oxymetazoline
  • Phenylephrine
  • Tetrahydrozoline
  • Tramazoline
  • Tymazoline
  • Xylometazoline.

Screenshot of vasoconstrictor eye drops

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