添付文書

Features

Quick! Effective against cold symptoms. Suitable for children aged 7 and over.
For those who want to take action quickly, those who want ingredients that are gentle on the stomach*1, and those who want to use it as a regular medicine for the whole family (ages 7 and over). Contains no codeine. *1 Acetaminophen
● ACE prescription comprehensive cold medicine
A comprehensive cold medicine formulated with the ACE formula, which contains two types of antipyretics and analgesics (acetaminophen and ethenzamide) and caffeine. It is effective against fever, sore throat, headache, and joint pain.
● For runny nose, stuffy nose, and sneezing
Contains the antihistamine chlorpheniramine maleate, which helps relieve runny nose, stuffy nose, and sneezing.
●Excellent effect on "cough" and "phlegm"
Contains dl-methylephedrine hydrochloride, a bronchodilator, which suppresses coughing and helps expel phlegm.




[Designated Category 2 OTC drug]




Efficacy and effectiveness

Relief of cold symptoms (fever, sore throat, cough, runny nose, stuffy nose, phlegm, sneezing, chills, headache, joint pain, muscle pain)




<Notes regarding efficacy and effectiveness>




Dosage and Administration

Take the next dose with water or lukewarm water, preferably within 30 minutes after a meal.
[Age: Single dose: Number of times per day]
Adults (15 years and older): 2 capsules, 3 times a day
Ages 7 to 15: 1 capsule, 3 times
Under 7 years old: Do not take





<Caution regarding usage and dosage>

(1) Please strictly follow the usage and dosage instructions.
(2) If the medicine is to be taken by a child between 7 and 14 years of age, it should be taken under the guidance and supervision of a parent or guardian.
(3) How to remove the capsule: Press firmly with your fingertips the raised part of the PTP sheet containing the capsule to break the aluminum foil on the back, then remove the capsule and take it.
(If swallowed by mistake, it may lead to unexpected accidents such as piercing the esophageal mucosa.)




Ingredients and quantities

The following ingredients are contained in 6 capsules (daily dose for adults).
Acetaminophen 500mg
Ethenzamide 400mg
Chlorpheniramine maleate 7.5mg
dl-Methylephedrine hydrochloride 40mg
Caffeine anhydrous 120mg




[Additives]

Corn starch, lactose hydrate, hydroxypropyl cellulose, gelatin, titanium oxide, sodium lauryl sulfate




<Notes regarding ingredients and quantities>




Dosage form

Long-acting capsules (oral capsules)




Usage notes

■Things you shouldn't do
(If you do not follow these instructions, your current symptoms may worsen, or you may be more susceptible to side effects or accidents.)
1. The following people should not take this medicine:
(1) People who have experienced allergic symptoms due to this drug or its ingredients.
(2) People who have experienced asthma after taking this drug or other cold medicines or antipyretics and analgesics.
2. Do not use any of the following medicines while taking this drug.
Other cold medicines, antipyretics, analgesics, sedatives, antitussives, expectorants, internal medicines containing antihistamines (internal medicines for rhinitis, motion sickness medicine, allergy medicine, etc.)
3. Do not drive or operate machinery after taking this medicine.
(Symptoms such as drowsiness, blurred vision, and abnormal glare may occur.)
4. Do not drink alcohol before or after taking this medicine.
5. Do not use for long periods of time
■Things to consult about
1. The following people should consult a doctor, pharmacist, or registered distributor before taking this medicine.
(1) A person receiving treatment from a doctor or dentist.
(2) Pregnant women or those thought to be pregnant.
(3) People who are breastfeeding.
(4) Infants, infants and children (under 15 years of age) who have or are suspected of having chickenpox or influenza.
(5) Elderly people.
(6) People who have experienced allergic symptoms due to medication, etc.
(7) People with the following symptoms: high fever, difficulty urinating
(8) People who have been diagnosed with the following:
Thyroid disorder, diabetes, heart disease, high blood pressure, liver disease, kidney disease, gastric and duodenal ulcers, glaucoma
2. If the following symptoms occur after taking this medicine, these may be side effects, so stop taking the medicine immediately and consult a doctor, pharmacist, or registered distributor with this package insert.
[Affected area: Symptoms]
Skin: rash, redness, itching
Digestive system: Nausea, vomiting, loss of appetite
Neuropsychiatric: Dizziness
Urinary system: Difficulty urinating
Other: Excessive hypothermia
In rare cases, the following serious symptoms may occur. If this occurs, consult a doctor immediately.
[Name of symptom: Symptom]
Shock (anaphylaxis): Immediately after taking the medicine, symptoms may include itchy skin, hives, hoarseness, sneezing, itchy throat, shortness of breath, palpitations, and confusion.
Stevens-Johnson syndrome: High fever, bloodshot eyes, eye discharge, sores on the lips, sore throat, widespread skin rash and redness, etc. may persist or suddenly worsen.
Drug hypersensitivity syndrome: Symptoms include widespread redness of the skin, generalized rash, fever, fatigue, and swelling of the lymph nodes (neck, armpits, groin, etc.).
Liver dysfunction: Symptoms include fever, itching, rash, jaundice (yellowing of the skin or whites of the eyes), brown urine, general fatigue, and loss of appetite.
Kidney damage: Symptoms include fever, rash, decreased urine output, generalized swelling, general fatigue, joint pain (pain in the joints), and diarrhea.
Interstitial pneumonia: When climbing stairs or exerting yourself slightly, you may experience shortness of breath, difficulty breathing, dry cough, fever, etc. These symptoms may appear suddenly or persist.
Asthma: Symptoms include wheezing, shortness of breath, etc.
Aplastic anemia: Symptoms include bruising, nosebleeds, bleeding gums, fever, pale skin and mucous membranes, fatigue, palpitations, shortness of breath, feeling unwell and dizzy, and blood in the urine.
Agranulocytosis: Sudden high fever, chills, sore throat, etc.
3. The following symptoms may occur after taking this medicine. If these symptoms persist or worsen, discontinue use and consult a doctor, pharmacist, or registered distributor with this package insert.
Dry mouth, drowsiness
4. If symptoms do not improve after taking the medicine 5 to 6 times (especially if fever lasts for 3 days or more or recurs), discontinue use and consult a doctor, pharmacist, or registered distributor with this package insert.




Storage and handling precautions

(1) Store in a cool, dry place away from direct sunlight.
(2) Keep out of reach of children.
(3) Do not transfer the product into other containers. (This may cause misuse or change the quality.)
(4) Do not take products after the expiration date* (listed on the outer box).