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TGA medicine labelling and packaging review

Consultation

24 May 2012

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Standardised information format: the Medicine Information Box

What is a Medicine Information Box?

A medicine information box is a standardised format for the information required on the labels of over-the-counter and complementary medicines. It is based on the "Drug Facts" box used by the US FDA to convey this information on over-the-counter medicines, as illustrated in Figure 6.

Figure 6: An example of a medicine information box.

Information is presented in the same format and consistent location on primary packaging and medicine containers to help consumers find the information they need to make informed decisions about their medicines.

What are the consumer health risks associated with not having a Medicine Information Box?

Currently there is no requirement for consistent placement and presentation of key medicine information that consumers need to make informed choices about the medicines they take and how to use them safely. Inconsistent placement of information such as dosage and usage instructions, precautions (including potential allergens) and storage instructions increases the risk that a medicine may be taken or stored inappropriately.

Available evidence indicates that defined and consistent formatting and presentation of information assists medicine consumers to identify and interpret the information they need to make effective decisions about their medications10.

Grouping information and the printing of the Medicine Information Box on blank space helps consumers to locate information about the medicine and allows easy comparison of different brands of medicine.

This approach also assists consumers to determine if a medicine is suitable for them as information regarding when not to take the medication and other warnings can be readily located.

Standardising information may also assist consumers to differentiate products under umbrella brands, or with names/packaging that look the same, as they will be able to easily locate the information required to identify medicines with the same active ingredients and avoid accidental overdoses.

Standardised formatting of information in this way is not intended to apply to the front of medicine packaging.

Proposed regulatory changes

4.1 Mandated information on labels and packaging of non-prescription medicines and complementary medicines is presented in a standardised Medicine Information box, based on the US FDA Drug Facts box. The mandatory headings are:

  • Active ingredient, including the amount in each dosage unit
  • Uses (indications)
  • Warnings and Allergy Information (including when the product should not be used and when to consult with a doctor or pharmacist. This section also includes information about possible side effects and substances or activities to avoid. The final lines of this section should include information about preservatives in the product.)
  • Directions/Dosage instructions
  • Storage information.

4.2 The font height for information must be no smaller than 1.5mm, with heading height at least 2mm.

4.3 The Medicine Information Box must have a white background with black text. Headings must be highlighted or bolded so they are sufficiently emphasised.

4.4 Where there is insufficient room on a single face of a package, the box may be split over more than one face. However, the overall format of the information is to remain the same. In these instances a pack insert may also be included containing the Medicine Information Box as a continuous table.

4.5 Information about the presence in the medicine of an allergen listed in Schedule 1 of TGO 69, which may be amended, must be included under the heading Warnings and Allergy Information.

4.6 For products containing more than 3 active ingredients, or products in small containers, there may be insufficient space on the medicine container or primary packaging for a complete Medicine Information Box. In these cases a complete Medicine Information Box should be included as a pack insert. The minimum information to be included on the label will include information under the following headings:

  • Directions
  • Warnings and Allergy Information.

Where space restrictions do not allow for the required information to be provided in the Medicine Information Box, an alternative arrangement or formatting of information should be provided to the TGA for assessment and approval, together with a justification for non-standardised presentation. This may include breaking the information over more than one panel, or reduction in font size.

General question on the proposed regulatory changes for Standardised Information Format: Medicine Information Box

To what extent do you think a standardised format for information on the labels of over-the-counter and complementary medicines will improve access to information for these medicines?

Are there other ways that the presentation of information could be improved?

Do you think the proposed requirements for products with more than three active ingredients (directions and warnings and allergy information), is sufficient for these products? Please propose an alternative if you don't agree with current recommendation.


Footnotes

  1. Shrank, W et al, Effect of Content and Format of Prescription Drug Labels on Medication Use; Ann Pharmacother 2007;41:783-801

Figures

Figure 6: An example of a medicine information box

*Images shown are not actual medicines or brands.

Example of the medicine information box

Figure 7: Illustration of how a medicine information box may be presented on a carton with all the required headings

*Images shown are not actual medicines or brands.

A hypothetical pharmacy medicine box illustrating the medicine information box from recommendation 4.1. The medicine information box contains the mandatory headings: Active ingredient, Uses, Directions, Warnings & allergy information, and Storage information.

Front Hypothetical pharmacy medicine box - front of box
Back Hypothetical pharmacy medicine box - back of box - Medicine Information Box, standardised format with mandatory headings
Left Hypothetical pharmacy medicine box - left side of box
Right Hypothetical pharmacy medicine box - right side of box
Top Hypothetical pharmacy medicine box - top of box
Bottom Hypothetical pharmacy medicine box - bottom of box

Figure 8: Illustration of how a medicine information box may be presented on a bottle

*Images shown are not actual medicines or brands.

A hypothetical complementary medicine bottle illustrating the medicine information box from recommendation 4.1. The medicine information box contains the mandatory headings: Active ingredient, Uses, Directions, Warnings & allergy information, and Storage information.

Front Hypothetical complementary medicine bottle - front of bottle
Back Hypothetical complementary medicine bottle  - back of bottle - standardised medicine information box with mandatory headings
Left Hypothetical complementary medicine bottle - left side of bottle - standardised medicine information box with mandatory headings
Right Hypothetical complementary medicine bottle - right side of bottle

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