6ARequirements relating to warning statements on labels

6A Requirements relating to warning statements on labels

Where more than one ingredient in a medicine (the relevant ingredients) must comply with a requirement, specified in column 4 of the table in Schedule 1 in relation to the ingredient, that a warning statement must be stated on the medicine label (the specified warning statement) in the form of either: (a) “In [rare/very rare] cases, [ingredient] may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching”; or (b) “In [rare/very rare] cases, [ingredient] may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain or dark urine”; the warning statement may be stated only once on the label of the medicine (the combined warning statement), provided that: (c) the combined warning statement lists all the relevant ingredients; and (d) if the specified warning statement for at least one of the relevant ingredients includes the words ‘in rare cases’—the combined warning statement includes the words ‘in rare cases’ instead of the words ‘in very rare cases’; and (e) if the specified warning statement for at least one of the relevant ingredients is in the form mentioned in paragraph (a)—the combined warning statement must be in the form mentioned in paragraph (a).