Document ID: chunk:federal_register_of_legislation:F2025L00049:schedule:3:p4
Version: federal_register_of_legislation:F2025L00049
Segment Type: schedule
Provision Reference: sch 3 (pt 4/8)
Character Range: 168591–171506

for oral use with a recommended single dose not exceeding 20 mg of hyoscine butylbromide in a pack containing 100 mg or less of hyoscine butylbromide when labelled for adults and children 6 years and over.
IBUPROFEN when:
 (a) either:

          (i) in divided preparations, each containing 400 mg or less of ibuprofen, in a primary pack containing not more than 50 dosage units; or

          (ii) in a modified release dosage form, each containing 600 mg of ibuprofen, in a primary pack containing not more than 32 dosage units; and
 (b) labelled:

          (i) with a recommended daily dose of 1200 mg or less of ibuprofen; and

          (ii) not for the treatment of children under 12 years;
 except when:
 (c) included in Schedule 2; or
 (d) in preparations for oral use that are labelled with a recommended daily dose of 1200 mg or less of ibuprofen in divided preparations, each containing 200 mg or less of ibuprofen, in a pack containing not more than 100 dosage units when:

          (i) ibuprofen is the only therapeutically active constitutent, other than phenylephrine or when combined with an effervescent agent; and

          (ii) packed in a blister or strip packaging or in a container with a child-resistant closure; and

          (iii) in a primary pack containing not more than 25 dosage units; and

          (iv) compliant with the requirements of the required advisory statements for medicine labels; and

          (v) not labelled for the treatment of children 6 years or under; and

          (vi) when combined with phenylephrine—not labelled for the treatment of children under 12 years.
INOSITOL NICOTINATE.
ISOCONAZOLE in preparations for vaginal use.
ISOSORBIDE DINITRATE in oral preparations containing 10 mg or less of isosorbide dinitrate per dosage unit.
KETOPROFEN in divided preparations for oral use containing 25 mg or less of ketoprofen per dosage unit in a pack containing 30 or less dosage units.
LANSOPRAZOLE in oral preparations containing 15 mg or less of lansoprazole per dosage unit for the relief of heartburn and other symptoms of gastro‑oesophageal reflux disease, in packs containing not more than 14 days' supply except when included in Schedule 2.
LEVONORGESTREL for emergency post‑coital contraception.
MACROGOLS in preparations for oral use for bowel cleansing prior to diagnostic, medical or surgical procedures.
MAGNESIUM SULFATE for human therapeutic use in divided oral preparations except when containing 1.5 g or less of magnesium sulfate per recommended daily dose.
MALATHION in preparations for human external use except in preparations containing 2% or less of malathion.
MANNITYL HEXANITRATE for therapeutic use.
MELATONIN in:
 (a) modified release tablets containing 2 mg or less of melatonin for monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep for adults aged 55 or over, in packs containing