[Product Name]Loxonin S Premium
[Indications/Effects]○ Relief of headache, menstrual pain (period pain), toothache, pain after tooth extraction, sore throat, lower back pain, joint pain, neuralgia, muscle pain, stiff shoulder pain, earache, bruise pain, fracture pain, sprain pain, and trauma pain
○ Fever reduction during chills and fever
[Storage Precautions](1) Store in a cool, dry place out of direct sunlight.
(2) Keep out of reach of children.
(3) Do not transfer to other containers. (This may cause misuse or change the quality.)
(4) Do not use products that have passed the indicated expiration date. Additionally, use within 12 months after opening the aluminum bag.
(5) Enter the date the aluminum bag was opened in the "Date of Opening" field on the box.
[Consumer Consultation Desk]Company Name: Daiichi Sankyo Healthcare Co., Ltd.
Address: 3-14-10 Nihonbashi, Chuo-ku, Tokyo 103-8234
Contact: Customer Service Department
Phone: 0120-337-336
Hours: 9:00–17:00 (excluding Saturdays, Sundays, and holidays)
Other: https://www.daiichisankyo-hc.co.jp/
[Manufacturer/Distributor]Daiichi Sankyo Healthcare

[Dosage and Administration]
AgeAmount per doseNumber of doses per day
Adults (15 years and older): 2 tablets, up to 2 times. When symptoms appear, take with water or lukewarm water, avoiding an empty stomach if possible.However, if symptoms reappear, a 3rd dose may be taken.Maintain an interval of at least 4 hours between doses. Do not use if under 15 years of age.
[Precautions for Use](1) Strictly follow the dosage and administration.(2) How to remove the tabletsPress firmly on the convex part of the PTP sheet containing the tablets with your fingertip to break the aluminum foil on the back, then remove and take the tablet. (Accidentally swallowing the sheet as is can lead to unexpected accidents such as piercing the esophageal mucosa.)
[Ingredients/Amount]In 2 tabletsLoxoprofen sodium hydrate: 68.1 mg(60 mg as anhydrous)Allylisopropylacetylurea: 60 mgAnhydrous caffeine: 50 mgMagnesium aluminometasilicate: 100 mg
[Ingredients/Additives]Lactose, cellulose, hydroxypropyl cellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, talc, ferric oxide, carnauba wax

■ Contraindications(Failure to follow these instructions may worsen current symptoms or increase the risk of side effects)
1. The following people should not take this medicine:(1) Persons who have had allergic symptoms to this drug or its ingredients.(2) Persons who have experienced asthma after taking this drug or other antipyretic analgesics or cold medicines.(3) Children under 15 years of age.(4) Persons receiving the following treatment at a medical institution:Gastric/duodenal ulcer, liver disease, kidney disease, heart disease.(5) Persons who have been pointed out by a doctor to have blood abnormalities (blood diseases) such as low red blood cell count (anemia), low platelet count (difficulty stopping bleeding, easy bleeding), or low white blood cell count.(6) Pregnant women within 12 weeks of their expected due date.
2. Do not take any of the following medicines while taking this drug:Other antipyretic analgesics, cold medicines, sedatives, motion sickness medicines.
3. Do not drive or operate machinery after taking this medicine.(Drowsiness etc. may occur)
4. Do not drink alcohol before or after taking this medicine.
5. Do not take for a long period of time.(If symptoms such as pain recur even after taking for 3 to 5 days, stop taking the medicine and seek medical attention from a doctor.)

■ Consultation
1. The following people should consult a doctor, dentist, or pharmacist before taking this medicine:(1) Persons receiving treatment from a doctor or dentist.(2) Persons who are pregnant or suspected of being pregnant.(3) Persons who are breastfeeding.(4) Elderly people.(5) Persons who have had allergic symptoms due to drugs, etc.(6) Persons who have received the following diagnosis:Bronchial asthma, ulcerative colitis, Crohn's disease, systemic lupus erythematosus, mixed connective tissue disease.(7) Persons who have had the following diseases:Gastric/duodenal ulcer, liver disease, kidney disease, blood disease.
2. If the following symptoms appear after taking this medicine, they may be side effects. Stop taking the medicine immediately and consult a doctor, dentist, or pharmacist with this document.(1) If symptoms such as excessive drop in body temperature, collapse (loss of strength), or coldness of extremities (cold hands and feet) appear after taking an antipyretic analgesic like this drug.(2) If peptic ulcer or swelling appears after taking this medicine.In rare cases, serious symptoms such as gastrointestinal bleeding (vomiting blood, nausea/vomiting, abdominal pain, black tarry stools, bloody stools, etc.), gastrointestinal perforation (a hole in the gastrointestinal tract; nausea/vomiting, severe abdominal pain, etc.), or stenosis/obstruction of the small or large intestine (nausea, vomiting, abdominal pain, abdominal bloating, etc.) may occur. In such cases, seek medical attention immediately.(3) If the following symptoms appear after taking this medicine:
Related area: SymptomsSkin: Rash/redness, itchingDigestive system: Abdominal pain, stomach discomfort, loss of appetite, nausea/vomiting, abdominal bloating, heartburn, stomatitis, indigestionCardiovascular system: Increased blood pressure, palpitationsNeuropsychiatric system: Drowsiness, numbness, dizziness, headacheOthers: Chest pain, malaise, facial flushing, fever, anemia, hematuriaIn rare cases, the following serious symptoms may occur. In such cases, seek medical attention immediately.Name of symptoms: SymptomsShock (Anaphylaxis): Itching of the skin, hives, hoarseness, sneezing, itchy throat, breathlessness, palpitations, clouding of consciousness, etc., appear immediately after taking.Blood disorder: Sore throat, fever, general malaise, paleness of the face and back of the eyelids, easy bleeding (gum bleeding, nosebleeds, etc.), bruising (color does not disappear when pressed), etc., appear.Oculo-muco-cutaneous syndrome (Stevens-Johnson syndrome): High fever, bloodshot eyes, eye discharge, lip sores, sore throat, widespread skin rash/redness, blisters appearing on red areas of the skin, small bumps (pustules) appearing on reddened skin, general malaise, loss of appetite, etc., persist or worsen rapidly.Toxic epidermal necrolysis: High fever, bloodshot eyes, eye discharge, lip sores, sore throat, widespread skin rash/redness, blisters appearing on red areas of the skin, small bumps (pustules) appearing on reddened skin, general malaise, loss of appetite, etc., persist or worsen rapidly.Erythema multiforme: High fever, bloodshot eyes, eye discharge, lip sores, sore throat, widespread skin rash/redness, blisters appearing on red areas of the skin, small bumps (pustules) appearing on reddened skin, general malaise, loss of appetite, etc., persist or worsen rapidly.Acute generalized exanthematous pustulosis: High fever, bloodshot eyes, eye discharge, lip sores, sore throat, widespread skin rash/redness, blisters appearing on red areas of the skin, small bumps (pustules) appearing on reddened skin, general malaise, loss of appetite, etc., persist or worsen rapidly.Kidney disorder: Fever, rash, decreased urine output, generalized swelling, general malaise, joint pain (aching joints), diarrhea, etc., appear.Congestive heart failure: General malaise, palpitations, shortness of breath, chest discomfort, chest pain, dizziness, fainting, etc., appear.Myocardial infarction: Tightening chest pain, breathlessness, cold sweat.Cerebrovascular disorder: Sudden appearance of decreased/loss of consciousness, difficulty moving limbs on one side, headache, vomiting, dizziness, difficulty speaking, difficulty getting words out, etc.Interstitial pneumonia: Shortness of breath/breathlessness when climbing stairs or exerting oneself slightly, dry cough, fever, etc., which appear suddenly or persist.Liver function disorder: Fever, itching, rash, jaundice (yellowing of the skin and whites of the eyes), brown urine, general malaise, loss of appetite, etc., appear.Rhabdomyolysis: Pain in muscles of the limbs, shoulders, lower back, etc., numbness in limbs, weakness, stiffness, general malaise, reddish-brown urine, etc., appear.Aseptic meningitis: Severe headache accompanied by neck stiffness, fever, nausea/vomiting, etc., appear. (Such symptoms have been reported frequently, especially in people receiving treatment for systemic lupus erythematosus or mixed connective tissue disease.)Asthma: Wheezing or whistling sounds when breathing, breathlessness, etc., appear.
3. The following symptoms may appear after taking this medicine. If such symptoms persist or intensify, stop taking the medicine and consult a doctor or pharmacist with this document.Dry mouth, constipation, diarrhea
4. If symptoms do not improve after taking 1 to 2 doses (as other diseases may be possible), stop taking the medicine and consult a doctor, dentist, or pharmacist with this document.