New Sedes Tablets

New Sedes Tablets

新セデス錠

Pain Relief
Designated Class 2 — Use with special caution
Drug Type

Combination analgesic and antipyretic (acetaminophen, ethenzamide, allylisopropylacetylurea, and caffeine)

Form

Tablets

Indication

Relief of headache, menstrual pain, toothache, neuralgia, lower back pain, traumatic pain, post-extraction pain, sore throat, earache, joint pain, muscle pain, shoulder stiffness pain, bruise pain, fracture pain, and sprain pain. Also for chills and fever.

Active Ingredients (per tablet)

Ethenzamide 200 mg
Acetaminophen 80 mg
Allylisopropylacetylurea 30 mg
Anhydrous caffeine 40 mg

Inactive Ingredients

Lactose hydrate, carmellose calcium, croscarmellose sodium, hydroxypropylcellulose, magnesium stearate

Instructions for Use

  • ✓Try to avoid taking on an empty stomach. Take with water or lukewarm water. Allow at least 4 hours between doses.
Age Dose per use Times per day
Adults (15 years and older) 2 tablets Up to 3 times daily
Children 7–14 years 1 tablet Up to 3 times daily
Under 7 years Do not use —
  • ✓Follow the recommended dosage strictly.
  • ✓Children should take under adult supervision.
  • ✓To remove a tablet, press firmly on the raised part of the blister sheet to break through the aluminum foil backing, then take the tablet out. Do not swallow the tablet while still inside the blister sheet, as it may pierce the esophageal lining and cause serious injury.
  • ✕Do not use if you have had an allergic reaction to this product or any of its ingredients.
  • ✕Do not use if you have had asthma triggered by this product, another pain reliever/fever reducer, or a cold medicine.
  • ✕Do not take together with other pain relievers/fever reducers, cold medicines, sedatives, or motion sickness medicines.
  • ✕Do not operate vehicles or machinery after taking this medicine, as drowsiness may occur.
  • ✕Do not drink alcohol before or after taking this medicine.
  • ✕Do not use long-term.
  • ✓Seek immediate medical attention if any of the following serious side effects occur:
  • • Shock (anaphylaxis): Itching, hives, hoarseness, sneezing, itchy throat, difficulty breathing, palpitations, or clouded consciousness shortly after taking.
  • • Stevens-Johnson syndrome / toxic epidermal necrolysis / acute generalized exanthematous pustulosis: High fever, eye redness, eye discharge, sores on the lips, sore throat, widespread skin rash or redness, small pustules on reddened skin, general malaise, or loss of appetite that persists or rapidly worsens.
  • • Drug-induced hypersensitivity syndrome: Widespread skin redness, generalized rash, fever, general malaise, or swollen lymph nodes in the neck, armpits, or groin.
  • • Liver dysfunction: Fever, itching, rash, jaundice (yellowing of the skin or whites of the eyes), dark urine, general malaise, or loss of appetite.
  • • Kidney disorder: Fever, rash, decreased urination, swelling throughout the body, general malaise, joint pain, or diarrhea.
  • • Interstitial pneumonia: Shortness of breath when climbing stairs or with slight exertion, difficulty breathing, dry cough, or fever that appears suddenly or persists.
  • • Asthma: Wheezing or whistling when breathing, or difficulty breathing.
  • ⚠Consult a doctor, dentist, pharmacist, or registered salesperson before use if you:
  • (1) Are under medical or dental treatment.
  • (2) Are pregnant or possibly pregnant.
  • (3) Are a child under 15 who has or may have chickenpox or influenza.
  • (4) Are elderly.
  • (5) Have had allergic reactions to medicines or other substances.
  • (6) Have been diagnosed with heart disease, kidney disease, liver disease, or gastric or duodenal ulcer.
  • ✓Stop use and consult a doctor, pharmacist, or registered salesperson, bringing this package insert with you, if any of the following occur after taking:
  • Skin: Rash, redness, itching
  • Gastrointestinal: Nausea/vomiting, loss of appetite
  • Nervous system: Dizziness
  • Other: Excessive drop in body temperature
  • ✓Drowsiness may occur after taking. If it persists or worsens, stop use and consult a doctor, pharmacist, or registered salesperson, bringing this package insert with you.
  • ✓If symptoms do not improve after 5–6 doses, stop and consult a doctor, dentist, pharmacist, or registered salesperson, bringing this package insert with you.
  • ✓Store in a cool, dry place away from direct sunlight. Keep out of reach of children. Do not transfer the tablets from the blister sheet to another container. Do not use after the expiry date.

Additional Information

A non-pyrazolone combination pain reliever and fever reducer containing four active ingredients. This medicine may cause drowsiness.

Sources & Documents

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For informational purposes only. Always consult a doctor or pharmacist before taking any medication.