Document ID: chunk:federal_register_of_legislation:F2025L00049:schedule:2:p13
Version: federal_register_of_legislation:F2025L00049
Segment Type: schedule
Provision Reference: sch 2 (pt 13/16)
Character Range: 152333–155364

than 50 tablets or capsules; or
 (d) in individually wrapped powders or sachets of granules enclosed in a primary pack containing not more than 25 wrapped powders or sachets of granules; or
 (e) in other preparations except:

          (i) when included in Schedule 3 or 4; or

          (ii) in individually wrapped powders or sachets of granules each containing 1000 mg or less of paracetamol as the only therapeutically active constituent (other than caffeine, phenylephrine and/or guaifenesin or when combined with effervescent agents) when:

             (A) enclosed in a primary pack that contains not more than 10 such powders or sachets of granules;

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

             (C) not labelled for the treatment of children 6 years of age or less; and

             (D) not labelled for the treatment of children under 12 years of age when combined with caffeine, phenylephrine and/or guaifenesin; or

          (iii) in tablets or capsules each containing 500 mg or less of paracetamol as the only therapeutically active constituent (other than caffeine, phenylephrine and/or guaifenesin or when combined with effervescent agents) when:

             (A) packed in blister or strip packaging or in a container with a child‑resistant closure;

             (B) in a primary pack containing not more than 16 tablets or capsules;

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

             (D) not labelled for the treatment of children 6 years of age or less; and

             (E) not labelled for the treatment of children under 12 years of age when combined with caffeine, phenylephrine and/or guaifenesin.
PARAFORMALDEHYDE (excluding its derivatives) for human therapeutic use except:
 (a) in oral hygiene preparations containing 0.1% or less of free formaldehyde; or
 (b) in other preparations containing 0.2% or less of free formaldehyde.
PHEDRAZINE.
PHENAZONE for human external use.
PHENIRAMINE:
 (a) in eye drops; or
 (b) when combined with one or more other therapeutically active substances in oral preparations when:

          (i) at least one of the other therapeutically active substances is a sympathomimetic decongestant; or

          (ii) in a day‑night pack containing pheniramine in the bed‑time dose where the day and night doses are in the same immediate container or immediate wrapper;
 except in preparations for the treatment of children under 2 years of age.
PHENOL, or any homologue boiling below 220°C, for human therapeutic use except:
 (a) when included in Schedule 4; or
 (b) in preparations for external use containing 1% or less of phenol and in preparations for external use containing 3% or less of cresols and xylenols and other homologues of phenol.
PHENYLEPHRINE except:
 (a) when included in Schedule 4; or
 (b) in oral preparations containing 50 mg or less of phenylephrine per recommended daily dose in packs containing 250 mg