Allegra FX (アレグラFX): ingredients, dose and warnings in English
Allegra FX (アレグラFX) is sold in Japan as a class 2 medicine: the box reads 第2類医薬品. In 2 tablets: Fexofenadine Hydrochloride 120 mg. The package insert sets the adult dose at 1 tablet, twice a day, for ages 15 and over.
第2類医薬品 · Class 2
What is in Allegra FX
The package insert lists 1 active ingredient in 2 tablets. The middle column is how each one is written on the Japanese box.
| Ingredient | Name on the box | Amount |
|---|---|---|
| Fexofenadine Hydrochloride | フェキソフェナジン塩酸塩 | 120 mg |
Additives, as written on the package insert (Japanese)
結晶セルロース,部分アルファー化デンプン,クロスカルメロースナトリウム(クロスCMC-Na),ステアリン酸マグネシウム,軽質無水ケイ酸,ヒプロメロース(ヒドロキシプロピルメチルセルロース),ポビドン,酸化チタン,マクロゴール400,三二酸化鉄,黄色三二酸化鉄
Source: PMDA (Pharmaceuticals and Medical Devices Agency) — アレグラFX: package insert (添付文書)
What the package insert lists it for
The approved wording of the Japanese package insert, translated. It is what the product is sold for, not advice on what to take.
- Relief of the following nasal allergy symptoms caused by pollen, house dust (indoor dust), etc.: sneezing, runny nose, blocked nose
The dose, as written on the package insert
Translated line by line from the directions and dosage (用法・用量) section.
- Fexofenadine Hydrochloride per dose
- 60 mg
- Adult dose
- 1 tablet
- Doses a day
- 2
- Age
- 15 and over
- Adults (15 and over): take 1 tablet per dose, 2 times a day, in the morning and evening.
| Age | Single dose | Number of doses |
|---|---|---|
| Adults (15 and over) | 1 tablet | 2 times a day, morning and evening |
| Under 15 | Do not take |
Notes on the directions
- (1) Follow the directions and dosage exactly as specified.
- (2) When using it for seasonal allergic rhinitis symptoms caused by pollen etc., it is effective to start taking it from the forecast date of pollen dispersal, or early on once symptoms begin to appear.
- (3) The effect is obtained by taking it continuously.
- (4) If your symptoms do not improve after taking it for 1 week, ask a doctor, pharmacist or registered salesperson for advice. Also, if you take it for more than 2 weeks, even if your symptoms have improved, ask a doctor, pharmacist or registered salesperson for advice.
- (5) How to take out the tablets
- Press the raised part of the sheet containing the tablet firmly with your fingertip to break the film on the back, then remove the tablet and take it. (Accidentally swallowing it still in the sheet can lead to unexpected accidents, such as it piercing the mucous membrane of the oesophagus.)
Do not
The package insert opens with what you must not do.
(If you do not follow these, your current symptoms may get worse, and side effects or accidents become more likely.)
1. Do not take it if you are one of the following people.
- (1) People who have had allergic symptoms caused by this medicine or its ingredients
- (2) Children under 15
2. Do not use any of the following medicines while taking this medicine.
- Other allergy medicines (including medicines for skin diseases and oral medicines for rhinitis), oral medicines containing antihistamines, etc. (cold medicines, cough medicines, motion sickness medicines, sleep aids and sedatives, etc.), preparations containing Aluminum Hydroxide/Magnesium Hydroxide (antacids), Erythromycin (antibiotic), Apalutamide (prostate cancer treatment)
3. Do not drink alcohol before or after taking it.
4. Women who are breastfeeding: do not take this medicine, or avoid breastfeeding if you take it.
- (Animal studies have shown that it passes into milk.)
Ask a doctor, pharmacist or registered salesperson
The package insert says to ask for advice in these cases.
1. If you are one of the following people, ask a doctor, pharmacist or registered salesperson for advice before taking it.
- (1) People who are receiving treatment from a doctor
- (2) People who do not know whether it is allergic rhinitis or due to another cause such as a cold
- (3) People who have been diagnosed with another allergic disease such as bronchial asthma or atopic dermatitis
- (4) People who have severe blocked nose symptoms
- (5) Women who are pregnant or think they may be pregnant
- (6) Older people
- (7) People who have had allergic symptoms caused by medicines etc.
2. If the following symptoms appear after taking it, they may be side effects, so stop taking it immediately and ask a doctor, pharmacist or registered salesperson for advice, taking this leaflet with you.
Possible side effects, by part of the body
- Skin
- swelling of the throat, eyelids, lips, etc., rash, itching, hives, the skin turning red
- Digestive system
- nausea, vomiting, abdominal pain, indigestion
- Nervous system
- a feeling of numbness, headache, fatigue, lethargy, dizziness, sleeplessness, nervousness, nightmares, sleep disorder
- Urinary system
- frequent urination, difficulty urinating
- Other
- palpitations, taste disturbance, oedema, chest pain, breathing difficulty, increased blood pressure, menstrual abnormalities
- In rare cases the following serious symptoms may occur. If they do, see a doctor immediately.
Rare but serious symptoms: name and signs
- Shock (anaphylaxis)
- right after taking it, itchy skin, hives, hoarseness, sneezing, itchy throat, difficulty breathing, palpitations, clouding of consciousness, etc. appear.
- Liver dysfunction
- fever, itching, rash, jaundice (the skin and the whites of the eyes turn yellow), brown urine, tiredness all over the body, loss of appetite, etc. appear.
- Agranulocytosis
- sudden high fever, chills, sore throat, etc. appear.
- Decreased white blood cell count
- sudden high fever, chills, sore throat, etc. appear.
- Decreased neutrophil count
- sudden high fever, chills, sore throat, etc. appear.
3. The following symptoms may appear after taking it, so if these symptoms continue or get worse, stop taking it and ask a doctor, pharmacist or registered salesperson for advice.
- Dry mouth, constipation, diarrhoea, drowsiness
Who can sell it in Japan
The Allegra FX box carries the class 第2類医薬品, which decides who may sell it.
- On the box
- 第2類医薬品 (Class 2). The box reads 第2類医薬品.
- Who can sell it
- A pharmacist or a registered salesperson may sell it.
Source: e-Gov law search (Digital Agency, Japan) — Pharmaceutical and Medical Device Act (医薬品医療機器等法), current text · e-Gov law search (Digital Agency, Japan) — Enforcement Regulations of the Pharmaceutical and Medical Device Act (施行規則), current text
Taking it home
Frequently asked questions
How much Fexofenadine Hydrochloride is in Allegra FX?
60 mg in a dose of 1 tablet, according to the Japanese package insert. The package insert lists 120 mg in 2 tablets.
How much Allegra FX can an adult take in a day?
The package insert sets the adult dose at 1 tablet, twice a day.
Can children take Allegra FX?
No. The package insert says it is not to be taken under 15.
Do I need a pharmacist to buy Allegra FX?
Allegra FX is a class 2 medicine (第2類医薬品). A pharmacist or a registered salesperson may sell it.
What is Allegra FX called in Japanese?
アレグラFX. The Allegra FX box also carries the class 第2類医薬品.
Related items
Package insert in Japanese: PMDA
Sources for this page
- PMDA (Pharmaceuticals and Medical Devices Agency) アレグラFX: package insert (添付文書)checked October 3, 2026
- e-Gov law search (Digital Agency, Japan) Pharmaceutical and Medical Device Act (医薬品医療機器等法), current textchecked October 3, 2026
- e-Gov law search (Digital Agency, Japan) Enforcement Regulations of the Pharmaceutical and Medical Device Act (施行規則), current textchecked October 3, 2026
Compiled by Japan Japan !! · Updated October 3, 2026