Package insert

● Features
● Exhibits excellent effects on severe allergy symptoms such as runny nose, nasal congestion, and sneezing caused by pollen and house dust for children (ages 7 to 14).
● This allergy-specific rhinitis medication is less likely to affect the brain, so it rarely causes drowsiness.
● It is a medicine that is also less likely to cause impaired performance such as decreased concentration, judgment, and work efficiency, which are hard to notice.
● With twice-daily dosing, the effect lasts for 24 hours.
● Can be taken on an empty stomach.
● Small and easy-to-swallow tablets.
* When used for seasonal allergic rhinitis symptoms such as pollen allergies, it is effective to start taking it early from the predicted pollen dispersal day or as soon as symptoms begin.

【Class 2 OTC Drug】

● Efficacy/Effects
Relief of the following nasal allergy symptoms caused by pollen, house dust (indoor dust), etc.: sneezing, runny nose, nasal congestion

<Precautions related to Efficacy/Effects>

● Dosage and Administration
Take the following amounts.
[Age: Dose per time: Frequency]
Children 7 to 11 years old: 1 tablet, twice daily (morning and evening)
Children 12 to 14 years old: 2 tablets, twice daily (morning and evening)
Children under 7 years old: Do not take

<Precautions related to Dosage and Administration>
(1) Strictly follow the prescribed dosage and administration.
(2) When giving to children, administer under the guidance and supervision of a guardian.
(3) When used for seasonal allergic rhinitis symptoms such as pollen allergies, it is effective to start taking it early from the predicted pollen dispersal day or as soon as symptoms begin.
(4) If symptoms do not improve after 3 to 4 days of use, discontinue use and consult a doctor, pharmacist, or registered seller. Also, if symptoms improve but use continues for more than 2 weeks, consult a doctor, pharmacist, or registered seller.
(5) How to remove tablets:
Press firmly on the raised part of the sheet containing the tablets with your fingertip to break the backing film and take out the tablet before taking it. (Swallowing the tablet while still in the sheet may cause unexpected accidents such as piercing the esophageal mucosa.)

● Ingredients/Quantity
Per 2 tablets:
Fexofenadine Hydrochloride 60 mg

〔Additives〕
Crystalline cellulose, partially alpha-starch hydrolysate, croscarmellose sodium (cross CMC-Na), magnesium stearate, light anhydrous silicic acid, hypromellose (hydroxypropyl methylcellulose), povidone, titanium dioxide, macrogol 400, ferric oxide black, ferric oxide yellow

<Precautions related to Ingredients/Quantity>

● Dosage Form
Tablet (oral tablet)

● Precautions for Use
This product is for children, but general precautions for oral rhinitis medications are described.
■Do not do (Contraindications)
(Not following these may worsen current symptoms or increase the risk of side effects or accidents.)
1. Do not take if:
 (1) You have had allergic reactions to this product or its ingredients.
 (2) You are under 7 years old.
2. Do not use any of the following medications while taking this product:
 Other allergy medications (including those for skin diseases and oral rhinitis), oral medications containing antihistamines (cold medicines, cough suppressants and expectorants, motion sickness drugs, hypnotics and sedatives, etc.), preparations containing aluminum hydroxide or magnesium hydroxide (antacids), erythromycin (antibiotic), apalutamide (prostate cancer treatment).
3. Do not drink alcohol before or after taking this medication.
4. Nursing mothers should either avoid taking this medication or avoid breastfeeding while taking it.
 (Animal studies have shown transfer into milk.)
■Consult
1. Consult a doctor, pharmacist, or registered seller before taking if:
 (1) You are receiving medical treatment.
 (2) You are unsure whether your symptoms are allergic rhinitis or caused by a cold or other reasons.
 (3) You have been diagnosed with other allergic diseases such as bronchial asthma or atopic dermatitis.
 (4) You have severe nasal congestion.
 (5) You are pregnant or think you may be pregnant.
 (6) You are elderly.
 (7) You have had allergic reactions to medications.
2. If the following symptoms appear after taking, stop use immediately and consult a doctor, pharmacist, or registered seller with this document as these may be side effects.
[Affected area: Symptoms]
Skin: swelling of throat, eyelids, lips, rash, itching, hives, redness of skin
Digestive system: nausea, vomiting, abdominal pain, indigestion
Central nervous system: numbness, headache, fatigue, malaise, dizziness, insomnia, nervousness, nightmares, sleep disorders
Urinary system: frequent urination, difficulty urinating
Others: palpitations, taste abnormalities, edema, chest pain, difficulty breathing, increased blood pressure, menstrual irregularities
 Rarely, the following serious symptoms may occur. In such cases, seek immediate medical attention.
[Name of Symptom: Symptoms]
Shock (anaphylaxis): Immediately after taking, itching skin, hives, hoarseness, sneezing, throat itching, difficulty breathing, palpitations, confusion of consciousness, etc.
Liver dysfunction: fever, itching, rash, jaundice (yellowing of skin or whites of eyes), dark urine, general fatigue, loss of appetite, etc.
Agranulocytosis: sudden high fever, chills, sore throat, etc.
Leukopenia: sudden high fever, chills, sore throat, etc.
Neutropenia: sudden high fever, chills, sore throat, etc.
3. The following symptoms may appear after taking; if these symptoms persist or worsen, stop use and consult a doctor, pharmacist, or registered seller:
Dry mouth, constipation, diarrhea, drowsiness

● Precautions for Storage and Handling
(1) Store in a cool, dry place away from direct sunlight.
(2) Keep out of reach of children.
(3) Do not transfer to another container. (This may cause misuse or quality changes.)
(4) Do not use products past the expiration date.