Medication info

Roafen S Soft Capsule

OTC medicationSoft capsule경구Approval withdrawn
Ingredient · strength
Acetaminophen›150mg / 1 capsuleEthenzamide›100mg / 1 capsuleAnhydrous Caffeine›25mg / 1 capsule
Manufacturer / importer
(주)서흥
Appearance
Yellow oval soft capsules containing white contents
Packaging
PTP - 10 capsules/PTP
Approval status
Approval withdrawn

MFDS item code 202006566 · Notified 2020.09.23

This product's status changed to Approval withdrawn on 2025.06.23. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of pain (such as headache, toothache) and fever
Who takes it
Adults · Children
Adult dose
Ages 15 and older: 2 capsules per dose, up to 3 times a day. Avoid taking on an empty stomach, and maintain a dosing interval of at least 4 hours.
Child dose
Children over 7 years to under 15 years: 1 capsule per dose, up to 3 times a day. Avoid taking on an empty stomach, and maintain a dosing interval of at least 4 hours.

Ingredients

Manufacturer
(주)서흥

Efficacy & effects

Relief of pain (such as headache, toothache) and fever

  • Headache
  • toothache
  • postoperative pain
  • sore throat
  • ear pain
  • joint pain
  • neuralgia
  • back pain
  • muscle pain
  • shoulder pain
  • contusion pain
  • fracture pain
View approved original text

This medication is used to relieve pain in various areas such as headache, toothache, sore throat, as well as muscle pain, joint pain, back pain, menstrual pain, and other types of pain. It is also effective in reducing chills and fever symptoms. Thus, it helps to alleviate discomfort due to pain and fever, improving the quality of life.

How to take

Adult dose

Ages 15 and older: 2 capsules per dose, up to 3 times a day. Avoid taking on an empty stomach, and maintain a dosing interval of at least 4 hours.

Child dose

Children over 7 years to under 15 years: 1 capsule per dose, up to 3 times a day. Avoid taking on an empty stomach, and maintain a dosing interval of at least 4 hours.

Precautions

This medication can put stress on the liver, so individuals who regularly consume more than three drinks per day should consult a doctor or pharmacist before taking it. During the use of this medication, severe reactions such as rash or blisters may occur on the skin. If such symptoms appear, stop taking the medication immediately and consult a professional. As it contains acetaminophen, care must be taken not to exceed the maximum daily dosage, and it should not be taken in conjunction with other acetaminophen-containing medications. Individuals allergic to this drug or its components, those who have experienced asthma or allergic reactions to this drug in the past, and infants under 3 months old should not take it. It should not be taken with other antipyretic analgesics, cold medicines, or sedatives. If you are taking other medications, you should consult a doctor or pharmacist. Children under 15 years old with suspected chickenpox or flu, people with specific allergic conditions, liver or kidney disease, elderly individuals, and women who are pregnant or breastfeeding should always consult a professional before use. If symptoms such as rash, itching, vomiting, dizziness, hearing abnormalities, or swelling occur after ingestion, stop taking the medication immediately and consult medical personnel. Emergency treatment should be sought immediately if severe allergic reactions or skin disorder symptoms occur. Strictly adhere to the prescribed dosage and duration and avoid prolonged use, and refrain from alcohol consumption during treatment. Keep this medication out of the reach of children and store it in a cool, dry place, avoiding direct sunlight and moisture. Additionally, it is crucial not to transfer this medication to a different container to maintain its quality.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor → severe allergic reaction
  • High fever accompanied by severe rash, blisters, skin peeling, pain in mouth/eye mucosa → severe skin adverse reactions
  • Asthma
  • Yellowing of the skin or eyes (jaundice), severe lethargy throughout the body → liver dysfunction (jaundice)

Mild side effects

  • Rash
  • redness (erythema)
  • itching
  • nausea
  • vomiting
  • loss of appetite
  • constipation
  • stomach pain
  • gastrointestinal bleeding
  • discomfort in the upper abdomen
Show 4 more
  • dizziness
  • hearing loss (deafness)
  • swelling (edema)
  • tinnitus (ringing in the ears)

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

Storage

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. The storage temperature should be maintained between 1°C and 30°C at room temperature.

Appearance and packaging

Appearance

Yellow oval soft capsules containing white contents

Package unit

PTP - 10 capsules/PTP

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.

Related searches

Search tags

Suggested searches

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.