Usage and Dosage (Precautions Related to Usage and Dosage)

Adults (15 years and older): Take 2 tablets at a time, up to twice a day. When symptoms appear, take the medication preferably on an empty stomach. However, if symptoms reappear, a third dose can be taken. The interval between doses should be at least 4 hours.

Individuals under 15 years: Do not take this medication.

How to take out the tablets: As shown in the diagram, press firmly with your fingertips on the protruded part of the blister pack containing the tablets, then tear open the aluminum foil on the back and take out the tablet to take it.

(Accidentally swallowing the tablet directly may cause injury such as piercing the esophageal mucosa.)

Ingredients and Raw Materials (Nutritional Components and Allergens)

Active ingredients and amounts per 2 tablets:
- Loxoprofen sodium hydrate: 68.1 mg (as anhydrous: 60 mg)
- Peony dry extract: 36 mg (equivalent to 252 mg of raw drug)
- Hesperidin: 30 mg
- Magnesium aluminum silicate: 100 mg

Additives: D-mannitol, cellulose, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide, macrogol, ferric trioxide, carnauba wax

Precautions for Use, Storage, and Handling

1. Do not take this medication if you are:
- (1) Someone who has had allergic reactions to this drug or its ingredients
- (2) Someone who has experienced asthma after taking this drug or other antipyretic/analgesic medications or cold medicines
- (3) Children under 15 years
- (4) Someone undergoing treatment at a medical facility for conditions such as gastric or duodenal ulcers, liver disease, kidney disease, or heart disease
- (5) Someone diagnosed with blood abnormalities such as low red blood cell count (anemia), low platelet count (easy bleeding or bleeding tendency), or low white blood cell count (blood disorders)
- (6) Pregnant women within 12 weeks of expected delivery

2. Do not take any other medications (including other antipyretic/analgesic drugs, cold medicines, sedatives) while taking this drug.

3. Do not consume alcohol before or after taking this medication.

4. Do not use continuously for long periods (if pain or symptoms recur after 3-5 days of use, stop taking the medication and consult a doctor).

Consultation

1. Before taking this medication, consult a doctor, dentist, or pharmacist if you are:
- (1) Under medical or dental treatment
- (2) Pregnant or suspected to be pregnant
- (3) Breastfeeding
- (4) Elderly
- (5) Have experienced allergic reactions to medications
- (6) Diagnosed with conditions such as bronchial asthma, ulcerative colitis, Crohn’s disease, systemic lupus erythematosus, or mixed connective tissue disease
- (7) Have had illnesses such as gastric or duodenal ulcers, liver disease, kidney disease, or blood disorders

2. If any of the following symptoms appear after taking the medication, discontinue immediately and consult a doctor, dentist, or pharmacist, as these may be side effects:
- (1) Symptoms such as excessive lowering of body temperature, collapse, limb cooling, etc., after taking an antipyretic/analgesic like this drug
- (2) Development of peptic ulcers or swelling
- (3) Rarely, gastrointestinal bleeding (vomiting blood, nausea, abdominal pain, black tarry stools, bloody stools), perforation (holes in the gastrointestinal tract), or severe narrowing/obstruction of the small or large intestine (nausea, vomiting, abdominal pain, bloating) may occur. Seek medical attention immediately if these occur.
- (4) Symptoms such as:
- Skin: Rash, redness, itching
- Digestive: Abdominal pain, indigestion, loss of appetite, nausea, vomiting, bloating, heartburn, stomatitis, indigestion
- Circulatory: Elevated blood pressure, palpitations
- Nervous system: Drowsiness, numbness, dizziness, headache
- Others: Chest pain, fatigue, facial flushing, fever, anemia, hematuria

Rarely, severe symptoms such as the following may occur. Seek medical attention immediately:
- Shock (anaphylaxis): Symptoms appear immediately after taking, including itching, hives, hoarseness, sneezing, throat itching, difficulty breathing, palpitations, altered consciousness
- Blood disorders: Sore throat, fever, general malaise, paleness of face or eyelids, easy bleeding (gum bleeding, nosebleeds), bruising that does not fade
- Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, acute generalized exanthematous pustulosis: High fever, conjunctival redness, eye discharge, lip sores, sore throat, widespread skin rash/redness, blisters on red skin, small pustules on red skin, persistent or rapidly worsening fatigue, loss of appetite
- Kidney impairment: Fever, rash, decreased urine output, swelling, malaise, joint pain, diarrhea
- Congestive heart failure: Fatigue, palpitations, shortness of breath, chest discomfort, chest pain, dizziness, fainting
- Interstitial pneumonia: Shortness of breath when climbing stairs or exerting, cough, fever, sudden or persistent symptoms
- Liver dysfunction: Fever, itching, rash, jaundice (yellowing of skin and eyes), dark urine, malaise, loss of appetite
- Rhabdomyolysis: Muscle pain in limbs, shoulders, hips; numbness, weakness, stiffness, dark reddish urine
- Aseptic meningitis: Severe headache with neck stiffness, fever, nausea, vomiting (more common in those treated for systemic lupus erythematosus or mixed connective tissue disease)
- Asthma: Wheezing, whistling sounds, difficulty breathing

3. If any of the following symptoms appear or persist/worsen, stop taking the medication and consult a doctor or pharmacist:
- Dry mouth, constipation, diarrhea

4. If symptoms do not improve after 1-2 doses (other illnesses may be involved), discontinue use and consult a healthcare professional.

Storage Precautions

- Store in a cool, dry place away from direct sunlight.
- Keep out of reach of children.
- Do not transfer to other containers (may cause misuse or deterioration).
- Do not use products past the expiration date printed on the package. After opening the aluminum pouch, use within 6 months.
- Record the date of opening on the "Open Date" section of the box.

Contact Information

Daiichi Sankyo Healthcare Consultation Office

TEL: 0120-013-416

Hours: 9:00–17:00 (excluding Saturdays, Sundays, public holidays, and company holidays)

Manufacturer: Daiichi Sankyo Healthcare

Address: 3-14-10 Nihonbashi, Chuo-ku, Tokyo

Product Category: "Class 1 OTC Drug"

*Please note that package designs and other details are subject to change without notice.*