Australian approved name (AAN):Plantago lanceolata
Common names and synonyms: English plantain; Narrowleaf plantain; Psyllium; Ribwort plantain
Warnings and Restrictions: The medicine requires the following warning statement on the medicine label:
CHILD5 – Use in children under 3 years is not recommended.
The requirement specified in paragraph (a) below applies to a medicine that contains the ingredient that:
– is listed in the Register on or after 2 March 2020; or
– is supplied after 2 March 2021.
(a) When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:
PSYLL1 – Should only be used for children on medical advice (or words to that effect).
The requirement specified in paragraph (b) below applies in relation to a medicine that contains the ingredient that:
– is listed in the Register before 2 March 2020; and
– is supplied before 2 March 2021; and
– does not have the warning statement (PSYLL1) on the label.
(b) When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:
PSYLL – On medical advice (or words to that effect).
Allowable purpose of the ingredient: Active. Excipient. Homeopathic