添付文書

● Features
This is a comprehensive cold medicine that exhibits excellent effects by double blending total alkaloids of belladonna and clemastine fumarate, which are effective for cold symptoms accompanied by severe runny nose and nasal congestion.
1. The nasal discharge suppressant ingredient, total alkaloids of belladonna, quickly dissolves after administration and exerts effects on nasal symptoms of colds such as runny nose.
2. The sustained antihistamine ingredient clemastine fumarate is also blended simultaneously. It continuously suppresses allergic symptoms of colds (runny nose, nasal congestion, etc.).
3. The anti-inflammatory ingredient ibuprofen exhibits excellent effects on sore throat and fever.
4. The expectorant ingredient bromhexine hydrochloride makes it easier to expel phlegm that causes cough, and dihydrocodeine phosphate and dl-methyl ephedrine hydrochloride suppress severe cough.
5. Convenient PTP packaging for portability.

【Designated Class 2 OTC Drug】

● Efficacy/Effects
Relief of various cold symptoms (runny nose, nasal congestion, sore throat, cough, phlegm, fever, chills, sneezing, headache, joint pain, muscle pain)

<Precautions related to Efficacy/Effects>

● Dosage and Administration
Take the following amount with water or hot water.
[Age: Single dose: Number of doses per day]
Adults (15 years and older): 2 tablets: 3 times a day. Take preferably within 30 minutes after meals.
Under 15 years old: Do not take.

<Precautions related to Dosage and Administration>
(1) Strictly follow the dosage and administration instructions.
(2) How to remove tablets
Press strongly with your fingertip on the convex part of the PTP sheet containing the tablets to break the aluminum foil on the back, then take out and take the tablet. (If swallowed as is by mistake, it may cause unexpected accidents such as piercing the esophageal mucosa.)

● Ingredients/Quantity
Per 6 tablets
Ibuprofen 450mg
Total alkaloids of belladonna 0.3mg
Clemastine fumarate 1.34mg
Bromhexine hydrochloride 12mg
Dihydrocodeine phosphate 24mg
dl-Methyl ephedrine hydrochloride 60mg
Anhydrous caffeine 75mg
Benfotiamine 25mg
Riboflavin 12mg

〔Additives〕
Corn starch, lactose, cellulose, croscarmellose sodium (cross CMC-Na), hydroxypropyl cellulose, magnesium stearate, polyvinyl alcohol-acrylic acid-methyl methacrylate copolymer, talc, titanium oxide, hypromellose (hydroxypropyl methylcellulose), carnauba wax

<Precautions related to Ingredients/Quantity>
Riboflavin (vitamin B2) contained in this medicine may cause urine to turn yellow.

● Dosage Form
Film-coated tablets (oral tablets)

● Precautions for Use
■Do not do (Contraindications)
(If not followed, current symptoms may worsen or side effects/accidents may occur more easily)
1. Do not take if you fall under any of the following:
(1) Those who have had allergic reactions to this medicine or its ingredients
(2) Those who have had asthma caused by this medicine or other cold medicines, antipyretic analgesics
(3) Children under 15 years old
(4) Pregnant women within 12 weeks before the expected delivery date
2. Do not use any of the following medicines while taking this medicine:
Other cold medicines, antipyretic analgesics, sedatives, antitussive expectorants, oral medicines containing antihistamines (oral medicines for rhinitis, motion sickness medicines, allergy medicines, etc.), gastrointestinal analgesics and antispasmodics
3. Do not drive vehicles or operate machinery after taking this medicine.
(Symptoms such as drowsiness, blurred vision, abnormal glare may appear)
4. Nursing mothers should either not take this medicine or avoid breastfeeding while taking it.
5. Do not drink alcohol before or after taking this medicine.
6. Do not take for more than 5 days.
■Consult
1. Consult a doctor, pharmacist, or registered seller before taking if you fall under any of the following:
(1) Those receiving treatment from a doctor or dentist
(2) Pregnant women or those who may be pregnant
(3) Elderly people
(4) Those who have had allergic reactions to drugs, etc.
(5) Those with the following symptoms: high fever, difficulty urinating
(6) Those diagnosed with the following: thyroid dysfunction, diabetes, heart disease, hypertension, liver disease, kidney disease, glaucoma, systemic lupus erythematosus, mixed connective tissue disease, respiratory dysfunction, obstructive sleep apnea syndrome, obesity
(7) Those who have had the following diseases: gastric/duodenal ulcer, ulcerative colitis, Crohn's disease
2. If the following symptoms appear after taking this medicine, they may be side effects. Stop taking immediately and consult a doctor, pharmacist, or registered seller with this document.
[Affected area: Symptoms]
Skin: rash, redness, itching, bruising
Digestive system: nausea, vomiting, loss of appetite, stomach discomfort, stomach pain, stomatitis, heartburn, indigestion, gastrointestinal bleeding, abdominal pain, diarrhea, bloody stool
Nervous system: dizziness, headache, excitement, convulsions
Circulatory system: palpitations
Respiratory system: shortness of breath
Urinary system: difficulty urinating
Others: blurred vision, tinnitus, swelling, nosebleed, bleeding gums, bleeding that is hard to stop, bleeding, back pain, excessive body temperature drop, fatigue, facial flushing, abnormal glare
Rarely, the following serious symptoms may occur. In such cases, seek medical attention immediately.
[Name of Symptom: Symptom]
Shock (anaphylaxis): Immediately after taking, itching of the skin, hives, hoarseness, sneezing, itching of the throat, difficulty breathing, palpitations, clouding of consciousness, etc. appear.
Stevens-Johnson syndrome (skin mucous membrane eye syndrome): High fever, eye redness, eye discharge, lip erosion, sore throat, widespread rash/redness of the skin persist or rapidly worsen.
Toxic epidermal necrolysis: High fever, eye redness, eye discharge, lip erosion, sore throat, widespread rash/redness of the skin persist or rapidly worsen.
Liver dysfunction: Fever, itching, rash, jaundice (yellowing of skin and whites of eyes), dark urine, general fatigue, loss of appetite, etc. appear.
Kidney disorder: Fever, rash, decreased urine output, generalized swelling, general fatigue, joint pain, diarrhea, etc. appear.
Aseptic meningitis: Severe headache with neck stiffness, fever, nausea, vomiting, etc. appear. (These symptoms are frequently reported especially in those receiving treatment for systemic lupus erythematosus or mixed connective tissue disease.)
Interstitial pneumonia: Shortness of breath or difficulty breathing when climbing stairs or exerting slightly, dry cough, fever, etc. appear suddenly or persist.
Asthma: Wheezing or whistling sounds when breathing, difficulty breathing, etc. appear.
Aplastic anemia: Bruising, nosebleeds, bleeding gums, fever, pale skin and mucous membranes, fatigue, palpitations, shortness of breath, dizziness, hematuria, etc. appear.
Agranulocytosis: Sudden high fever, chills, sore throat, etc. appear.
Respiratory depression: Shortness of breath, difficulty breathing, etc. appear.
3. The following symptoms may appear after taking this medicine. If these symptoms persist or worsen, stop taking and consult a doctor, pharmacist, or registered seller with this document.
Constipation, dry mouth, drowsiness
4. If symptoms do not improve after 5 to 6 doses, stop taking and consult a doctor, pharmacist, or registered seller with this document.
(Especially if fever lasts more than 3 days or recurs)

●Precautions for Storage and Handling
(1) Store in a cool, dry place away from direct sunlight.
(2) Keep out of reach of children.
(3) Do not transfer to other containers. (This may cause misuse or quality changes.)
(4) Do not use products past the indicated expiration date. Also, use within 9 months after opening the aluminum bag.
(5) Write the date of opening the aluminum bag in the "Opening Date" section on the box.