Medication info

Acetophen Soft Capsule

OTC medicationSoft capsule경구Approval withdrawn
Ingredient · strength
Acetaminophen›500mg / 1 capsuleRiboflavin Butyrate›6mg / 1 capsule
Manufacturer / importer
(주)알피바이오
Appearance
A reddish-brown soft capsule containing yellow contents.
Packaging
For domestic use - 10 capsules/box [10 capsules/PTP x 1]
Approval status
Approval withdrawn

MFDS item code 202302028 · Notified 2023.07.03

This product's status changed to Approval withdrawn on 2026.01.06. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Pain relief for headaches, toothaches, and antipyretic effect for fevers.
Who takes it
Adults
Adult dose
For individuals aged 15 years and older, take 1 capsule 1 to 2 times a day. The interval between doses must be at least 6 hours. Avoid taking on an empty stomach.

Ingredients

Manufacturer
(주)알피바이오

Efficacy & effects

Pain relief for headaches, toothaches, and antipyretic effect for fevers.

  • Headaches
  • toothaches
  • pain after tooth extraction
  • sore throat
  • ear pain
  • joint pain
  • neuralgia
  • lower back pain
  • muscle pain
  • shoulder pain
  • bruising pain
  • fracture pain
View approved original text

This medication is effective for relieving various types of pain, including headaches, toothaches, pain after tooth extraction, sore throat, ear pain, joint pain, neuralgia, lower back pain, and muscle pain. It also reduces pain from bruises, fractures, sprains, menstrual cramps, and traumatic injuries. It improves symptoms of chills and fever through its antipyretic action. It is used for a variety of pain and fever symptoms.

How to take

Adult dose

For individuals aged 15 years and older, take 1 capsule 1 to 2 times a day. The interval between doses must be at least 6 hours. Avoid taking on an empty stomach.

Precautions

This medication should be used with caution in individuals who regularly consume more than three drinks a day, as it may cause liver damage; you must consult a doctor or pharmacist before use. Additionally, if severe rashes or blistering symptoms appear during treatment, you should stop taking the medication immediately and consult a specialist. This medication contains acetaminophen, so care must be taken not to exceed the maximum daily dose of 4,000 mg, and it should not be taken with other acetaminophen-containing products. People with allergies to this medication or any of its ingredients, those who have experienced asthma attacks, and infants under the age of 3 months should not take this medication. During treatment, it is safer to avoid combining with other antipyretic analgesics, cold medications, or sedatives. Children suspected of having chickenpox or influenza, people with allergic conditions, liver, kidney, or heart disease, elderly patients, pregnant or breastfeeding women must consult a specialist before taking this medication. If symptoms such as rashes, vomiting, dizziness, or swelling occur during use, you should stop taking it immediately and consult a doctor or pharmacist, especially if there are severe allergic reactions, mucosal skin symptoms, asthma attacks, or liver function abnormalities; immediate medical attention should be sought. Children under 2 years old are generally prohibited from taking this medication, and if absolutely necessary, a physician's assessment is required. Adhere strictly to the dosage and duration, do not use for extended periods, and avoid alcohol during use. Also, as interactions with certain medications may increase the risk of side effects, it is important to consult a specialist.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (edema), chest tightness, cold sweat, paleness → severe allergic reactions
  • High fever with severe rashes, blisters, peeling skin, pain in mucous membranes of the mouth/eyes → severe skin adverse reactions
  • Shortness of breath or difficulty breathing, asthma attacks, abnormal respiratory symptoms with cough + fever
  • Yellowing of the skin or eyes (jaundice), profound fatigue throughout the body → liver damage (jaundice)

Mild side effects

Rash, redness (hyperemia), itching, nausea, vomiting, loss of appetite, constipation, dizziness, swelling, high anion gap metabolic acidosis (HAGMA)

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

Storage

This medication should be stored in a sealed container to prevent exposure to air or moisture. It is best kept at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

A reddish-brown soft capsule containing yellow contents.

Package unit

For domestic use - 10 capsules/box [10 capsules/PTP x 1]

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

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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.