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Pseudoephedrine in Japan (the ingredient of Sudafed): products and rules

Pseudoephedrine: how it is named on Japanese boxes, the 2 products in this database that contain it, how their doses compare with US labels, and the rules for bringing it into Japan and taking it home. On 3 October 2026, PMDA's search of OTC package inserts returned 85 products containing pseudoephedrine.

Updated

85OTC products in PMDA search
2In this database

要確認 ingredient

What it is called on Japanese boxes

How pseudoephedrine is written on Japanese boxes, with the official English name from the JAN database or the Japanese Pharmacopoeia.

Pseudoephedrine: official names in Japan (JAN database and Japanese Pharmacopoeia, checked 3 October 2026)
Official English nameName on Japanese boxesListed in
Pseudoephedrine Hydrochloride塩酸プソイドエフェドリンMinistry specification

Pseudoephedrine in Japanese products

The amount of pseudoephedrine per dose and per day, as each package insert sets it.

On 3 October 2026, PMDA's search of OTC package inserts returned 85 products containing pseudoephedrine.

Pseudoephedrine in Japanese OTC medicines in this database, from each package insert (PMDA, checked 3 October 2026)
ProductAmountMost a day for adultsClass on the box
Pabron Rhinitis Capsules Sα60 mg per dose of 2 capsules120 mg (2 doses a day)第②類医薬品
Allegra FX Premium120 mg per dose of 2 tablets240 mg (2 doses a day)要指導医薬品

Most a day for adults, by the package insert (mg)

Pabron Rhinitis Capsules Sα120 mg
Allegra FX Premium240 mg

Each package insert sets its own dose. Follow the directions and dosage on the box you buy.

Japanese doses and US labels

US doses come from the OTC labels on DailyMed.

Pseudoephedrine: Japanese package inserts and US OTC labels side by side (PMDA and DailyMed, checked 3 October 2026)
ProductWhereAmountMost a day for adults
Pabron Rhinitis Capsules SαJapan, package insert60 mg per dose of 2 capsules120 mg (2 doses a day)
Allegra FX PremiumJapan, package insert120 mg per dose of 2 tablets240 mg (2 doses a day)
Sudafed Sinus CongestionUS, OTC label30 mg per tablet240 mg (8 tablets in 24 hours)
Sudafed Sinus Congestion 12 HourUS, OTC label120 mg per tablet240 mg (2 tablets in 24 hours)

Follow the directions and dosage exactly.That is the wording of the Japanese package inserts. The table lines up what each product's own directions say; it is not a guide to how much to take.

US Food and Drug AdministrationThe sale of cold medicine containing pseudoephedrine is limited to behind the counter. The amount of pseudoephedrine that an individual can purchase each month is limited and individuals are required to present photo identification to purchase products containing pseudoephedrine.FDA

The directions on the US labels, as printed

Sudafed Sinus Congestion: directions for adults (DailyMed, US label)adults and children 12 years and over: take 2 tablets every 4 to 6 hours / do not take more than 8 tablets in 24 hoursDailyMed
Sudafed Sinus Congestion 12 Hour: directions for adults (DailyMed, US label)adults and children 12 years and over: take 1 tablet every 12 hours / do not take more than 2 tablets in 24 hoursDailyMed

Bought with a check in Japan (要確認)

From 1 May 2026, medicines taken by mouth that contain pseudoephedrine are designated abuse-prevention medicines (指定濫用防止医薬品).

Bringing it into Japan

Japan lists pseudoephedrine as a stimulants' raw material. Substances containing 10% or less are excluded from the list; medicine above that needs a prescription and permission obtained before you enter Japan.

Taking it home

What the official customs pages say about pseudoephedrine. Check them before you fly.

  • South Korea: Single-ingredient medicines containing ephedrine, norephedrine or pseudoephedrine need a requirement check even within the 6-bottle allowance.

Source: Korea Customs Service (National Law Information Center) — Notice on import clearance, Annex 11 (수입통관 사무처리에 관한 고시 별표 11), in force 17 December 2025

Frequently asked questions

Is pseudoephedrine sold over the counter in Japan?

On 3 October 2026, PMDA's search of OTC package inserts returned 85 products containing pseudoephedrine. In this database: Pabron Rhinitis Capsules Sα, Allegra FX Premium.

How much Pseudoephedrine Hydrochloride is in Pabron Rhinitis Capsules Sα?

60 mg per dose of 2 capsules, and at most 120 mg (2 doses a day) by its package insert.

How does Pabron Rhinitis Capsules Sα compare with Sudafed Sinus Congestion?

Pabron Rhinitis Capsules Sα: 60 mg per dose of 2 capsules, at most 120 mg (2 doses a day) (Japanese package insert). Sudafed Sinus Congestion: 30 mg per tablet, at most 240 mg (8 tablets in 24 hours) (US label). Each product's directions apply only to that product.

Can I bring pseudoephedrine into Japan?

Japan lists pseudoephedrine as a stimulants' raw material. Substances containing 10% or less are excluded from the list; medicine above that needs a prescription and permission obtained before you enter Japan.

Why does a Japanese shop check before selling pseudoephedrine?

From 1 May 2026, medicines containing any of 8 ingredients are designated abuse-prevention medicines (指定濫用防止医薬品): ephedrine, codeine, dihydrocodeine, diphenhydramine, dextromethorphan, pseudoephedrine, bromovalerylurea and methylephedrine, with their hydrates and salts. Medicines for external use are not included.

Related items

PMDA package insert search (Japanese)

Sources for this page

Back to Japanese OTC medicine

Compiled by Japan Japan !! · Updated October 3, 2026