PMDA drug package insert

アセトアミノフェン坐剤小児用50mg「シオエ」

PMDA Prescription drug · 日本新薬株式会社 · package insert Aug 25, 2026

Key facts

Brand names アセトアミノフェン坐剤小児用50mg「シオエ」, アセトアミノフェン坐剤小児用100mg「シオエ」, アセトアミノフェン坐剤小児用200mg「シオエ」
Nonproprietary names アセトアミノフェン
Companies 製造販売元/シオエ製薬株式会社 販売 /日本新薬株式会社
Product type Prescription drug
Therapeutic category 小児用解熱鎮痛剤
Therapeutic category codes 871141
YJ codes 1141700J1134, 1141700J2203, 1141700J3170
Approval numbers 30200AMX00730, 30200AMX00728, 30200AMX00729
Package insert edition 第3版
Package insert date Aug 25, 2026
PMDA document key 340013_1141700J1134_1
PMDA company code 340013

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None Safety communications
  • No PMDA review report published
  • No Risk management plan (RMP)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMDA approved drugs and package inserts (Japan)

Japan's PMDA publishes the package insert (添付文書) of every prescription drug, OTC drug and regenerative medical product, with brand and nonproprietary names, YJ codes and approval numbers. Names appear in Japanese as published.

Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, package insert database · Source date:

Browse all PMDA approved drugs and package inserts (Japan)