Medication info
Setapen 8 Hour Sustained Release Tablets 650 mg (Acetaminophen)

Setapen 8 Hour Sustained Release Tablets 650 mg (Acetaminophen)

OTC medicationTablet
Ingredient · strength
Acetaminophen›325mg / 1 tablet
Manufacturer / importer
(주)보령바이오파마
Appearance
White, oblong sustained-release film-coated tablets
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 201906975 · Approved 2019.09.30 · Insurance code 670501910

Summary

Main use
Fever reduction and relief of cold symptoms (pain, headache)
Who uses it
Adults · Children
Adult dosage
Take 2 tablets every 8 hours, not exceeding 6 tablets in a 24-hour period.
Children's dosage
Children aged 12 years and older should take 2 tablets every 8 hours, not exceeding 6 tablets in a 24-hour period.

Ingredients

Manufacturer
(주)보령바이오파마

Efficacy & effects

Fever reduction and relief of cold symptoms (pain, headache)

  • Fever reduction
  • pain due to colds
  • headache
  • toothache
  • muscle pain
  • back pain
  • menstrual cramps
  • joint pain
View approved original text

This medication is used to reduce fever and relieve pain associated with colds, including headaches, toothaches, muscle pain, back pain, menstrual cramps, and joint pain.

Dosage and Administration

Adult dosage

Take 2 tablets every 8 hours, not exceeding 6 tablets in a 24-hour period.

Children's dosage

Children aged 12 years and older should take 2 tablets every 8 hours, not exceeding 6 tablets in a 24-hour period.

Precautions

This medication carries a risk of liver damage, so individuals who regularly consume more than three alcoholic beverages daily must consult a doctor or pharmacist before use. If a rash or severe allergic reaction occurs while taking this medication, discontinue use immediately and consult a healthcare professional. The maximum daily dosage of acetaminophen included in this medication is 4,000 mg; exceeding this amount may cause serious liver damage, so it should not be taken with other products containing acetaminophen. Individuals with hypersensitivity, peptic ulcers, severe blood disorders, liver or kidney impairment, or diminished heart function should not take this medication. Individuals with a history of aspirin-induced asthma or those currently taking certain medications, as well as children under the age of 12, should not take this medication. Since this is a sustained-release formulation, do not crush, chew, or dissolve the tablets; swallow them whole, and do not alter the method of administration without medical advice. If you have liver or kidney disease, peptic ulcers, blood disorders, a tendency to bleed, asthma, are elderly, pregnant, or breastfeeding, or are taking certain medications, consult a healthcare professional before taking this medication. If symptoms such as difficulty breathing, facial swelling, severe allergic reactions, severe nausea, gastrointestinal bleeding, or skin rashes occur while taking this medication, discontinue use immediately and notify a healthcare provider. Long-term use requires regular blood tests and liver function tests; if abnormalities are found, it may be necessary to adjust or discontinue the dosage. In cases of overdose, visit a hospital promptly for liver protection treatment even if there are no symptoms. This medication should be stored in a tightly sealed container and kept in a cool place out of reach of children, and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, anaphylactic reaction, hypersensitivity, skin rash, severe allergic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis, respiratory distress, asthma attacks, jaundice (yellowing of skin or eyes), extreme fatigue, shock, acute generalized exanthematous pustulosis, severe swelling accompanied by elevated blood pressure, severe swelling, or urination issues.

Mild side effects

Nausea, vomiting, loss of appetite, pruritic (itchy) rash, rash, elevated AST, elevated ALT, fixed rash, thrombocytopenia, agranulocytosis, hemolytic anemia, methemoglobinemia, impaired platelet function (prolonged bleeding time), cyanosis, facial swelling, profuse sweating, hypotension, gastrointestinal bleeding, peptic ulcer, perforation, high-anion-gap metabolic acidosis (HAGMA), chronic liver necrosis, acute pancreatitis, chronic hepatitis, nephrotoxicity, liver, kidney

Not everyone experiences these, and they can vary from person to person.

Interactions

Drug interactions

Consult a doctor or pharmacist when taking this medication with barbiturates, tricyclic antidepressants, lithium, or thiazide diuretics.

Food interactions

Caution is required when taking this medication with alcohol.

Storage

This medication should be stored in a sealed container to prevent air from entering and kept at room temperature between 1°C and 30°C. Storing it this way will help maintain the efficacy of the medication.

Appearance and packaging

Appearance

White, oblong sustained-release film-coated tablets

Package unit

30 tablets/bottle, 500 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.