Calonal Tablet 500 [Class 1 Drugs]

Reported adverse reactions include cyanosis (skin, lips and nails turning blueish purple), decrease of platelet function (prolongation of bleeding time), nausea/vomiting, loss of appetite and hypersensitivity (eruption). If any of these symptoms occur, consult with your doctor or pharmacist.

The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.

• breathing difficulty, generalized flushing, hives [shock, anaphylaxis]
• high fever, eruptions or blisters on skin or mucosa, bloodshot eyes[toxic epidermal necrolysis, Stevens-Johnson syndrome, and acute generalized exanthematous pustulosis]
• breathing difficulty, wheezing (whistling sound)[induction of asthma attacks]
• malaise, loss of appetite, yellowing in skin and white of eyes[fulminant hepatitis, liver dysfunction, jaundice]
• sore throat, fever[granulocytopenia]
• breathing difficulty, cough, fever[interstitial pneumonia]
• fever, rash, joint pain[interstitial nephritis, acute renal dysfunction]
• extensive skin redness, generalized rash, fever[drug-induced hypersensitivity syndrome]

The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

• Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))
• For analgesia in various diseases and symptoms: In general, for adults, take 300 to 1,000 mg of the active ingredient at a time. The dosage interval should be longer than 4 to 6 hours. The maximum daily dose is up to 4,000 mg. Avoid taking this medicine on an empty stomach.
  For antipyresis and pain relief in acute upper respiratory inflammation: In general, for adults, take 300 to 500 mg of the active ingredient at a time as needed. As a rule, up to twice a day and the maximum daily dose is up to 1,500 mg. Avoid taking this medicine on an empty stomach.
  For antipyresis and pain relief in pediatric diseases: In general, for infants and children, take 10 to 15 mg of the active ingredient per kilogram of the body weight at a time. The dosage interval should be longer than 4 to 6 hours. The maximum daily dose is up to 60 mg per kilogram of the body weight. However, the dosage should not exceed the adult dosage (the maximum single dose is up to 500 mg and the maximum daily dose is up to 1,500 mg). Avoid taking this medicine on an empty stomach.
  In any case, the dosage may be adjusted according to age or symptoms. This preparation contains 500mg of the active ingredient in a tablet. The maximum single dose is 300 mg of acetaminophen for patients with have aspirin asthma or have a history of it. Strictly follow the instructions.
• If you miss a dose, take the missed dose as soon as possible. However, if it is almost time for the next dose (no more than 4 hours), skip the missed dose and follow your regular dosing schedule. You should never take two doses at one time.
• If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
• Do not stop taking this medicine unless your doctor instructs you to do so.

• If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines or foods.
• If you have: liver disorder, aspirin-induced asthma or its history.
• If you are pregnant or breastfeeding.
• If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

• Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
• Discard the remainder. Do not store them. If you don’t know how to discard, consult your pharmacy or medical institution about how to discard them. Do not give this medicine to anyone else.