Colgen Kowa IB Tablets TX Alpha

Colgen Kowa IB Tablets TX Alpha

コルゲンコーワIB錠TXα

Cold Medicine
Designated Class 2 — Use with special caution
Abuse-Prevention Designated · 指定濫用防止医薬品
Drug Type

Cold medicine

Form

Tablets 45 tablets

Indication

Relief of cold symptoms: sore throat, fever, chills, headache, cough, phlegm, runny nose, nasal congestion, sneezing, joint pain, and muscle pain

Active Ingredients (per 9 tablets (daily dose))

Ibuprofen 600 mg
Tranexamic acid 750 mg
Ambroxol hydrochloride 45 mg
d-Chlorpheniramine maleate 3.5 mg
Dihydrocodeine phosphate 24 mg
dl-Methylephedrine hydrochloride 60 mg
Anhydrous caffeine 75 mg

Inactive Ingredients

Anhydrous silicic acid, hypromellose, citric acid, lactose, calcium silicate, hydroxypropyl cellulose, carmellose calcium, magnesium stearate, triacetin, talc, titanium oxide, yellow No. 5, carnauba wax

Instructions for Use

  • ✓Take within 30 minutes after meals with water or warm water.
Age Dose per use Times per day
Adults (15 years and older) 3 tablets 3 times a day
Under 15 years Do not use —
  • ✓When removing tablets from the PTP sheet, press the convex side firmly to break the foil on the back. Do not swallow the PTP sheet, as it may puncture the esophageal lining and cause serious injury.
  • ✕Do not use this product if you:
  • Have had an allergic reaction to this product or any of its ingredients.
  • Have had asthma caused by this product, other cold medicines, or pain relievers.
  • Are under 15 years of age.
  • Are currently being treated at a medical facility for gastric or duodenal ulcer, blood disorder, liver disease, kidney disease, heart disease, or high blood pressure, or are taking zidovudine (Retrovir).
  • Are within 12 weeks of your expected delivery date.
  • ✕Do not use any of the following medicines while taking this product: other cold medicines, pain relievers, sedatives, cough and phlegm medicines, medicines containing antihistamines (nasal allergy medicines, motion sickness medicines, allergy medicines), or medicines containing tranexamic acid.
  • ✕Do not drive or operate machinery after taking this product (may cause drowsiness).
  • ✓If breastfeeding, do not take this product, or avoid breastfeeding while taking it.
  • ✕Do not drink alcohol before or after taking this product.
  • ✕Do not use for more than 5 days.
  • ✕Do not exceed the recommended dose.
  • ✓Seek immediate medical attention if any of the following serious symptoms appear:
  • • Shock (anaphylaxis): Itching of skin, hives, hoarseness, sneezing, itchy throat, difficulty breathing, palpitations, or clouding of consciousness immediately after use.
  • • Stevens-Johnson syndrome / toxic epidermal necrolysis: High fever, redness of eyes, eye discharge, sores on lips, sore throat, or widespread rash or redness on skin that persists or rapidly worsens.
  • • Liver disorder: Fever, itching, rash, jaundice (yellowing of the skin or whites of the eyes), dark urine, general fatigue, or loss of appetite.
  • • Kidney disorder: Fever, rash, decreased urine output, swelling throughout the body, general fatigue, joint pain, or diarrhea.
  • • Aseptic meningitis: Severe headache with stiff neck, fever, nausea, or vomiting. (More commonly reported in people being treated for systemic lupus erythematosus or mixed connective tissue disease.)
  • • Myocardial infarction: Tightening chest pain, difficulty breathing, or cold sweats.
  • • Cerebrovascular disorder: Sudden onset of decreased or loss of consciousness, difficulty moving one side of the body, headache, vomiting, dizziness, or difficulty speaking.
  • • Interstitial pneumonia: Shortness of breath or difficulty breathing with exertion, dry cough, or fever that appears suddenly or persists.
  • • Asthma: Wheezing or difficulty breathing.
  • • Blood disorder: Sore throat, fever, general fatigue, pale face or inner eyelids, or easy bleeding (bleeding gums or nosebleeds).
  • • Digestive disorder: Black stools, vomiting blood, bloody stools, or mucus- and blood-mixed soft stools.
  • • Respiratory depression: Shortness of breath or difficulty breathing.
  • ⚠Consult a doctor, pharmacist, or registered salesperson before use if you:
  • (1) Are under the care of a physician or dentist.
  • (2) Are pregnant or may be pregnant.
  • (3) Are elderly.
  • (4) Have ever had an allergic reaction to a medicine.
  • (5) Have any of the following symptoms: high fever, or difficulty urinating.
  • (6) Have been diagnosed with: thyroid disorder, diabetes, glaucoma, systemic lupus erythematosus (SLE), mixed connective tissue disease, thrombosis (cerebral thrombosis, myocardial infarction, or thrombophlebitis) or risk of thrombosis, bronchial asthma, respiratory impairment, obstructive sleep apnea syndrome, or obesity.
  • (7) Have a history of: gastric or duodenal ulcer, ulcerative colitis, Crohn's disease, blood disorder, liver disease, or kidney disease.
  • ✓Stop use and consult a doctor, pharmacist, or registered salesperson — bringing this package insert with you — if any of the following symptoms appear after taking this product, as they may be side effects:
  • Skin: Rash, redness, or itching
  • Gastrointestinal: Nausea/vomiting, loss of appetite, stomach discomfort, stomach pain, mouth sores, heartburn, stomach heaviness, gastrointestinal bleeding, abdominal pain, diarrhea, or abdominal bloating
  • Nervous system: Dizziness, insomnia, or low mood
  • Cardiovascular: Palpitations
  • Respiratory: Shortness of breath
  • Urinary: Difficulty urinating
  • Other: Blurred vision, ringing in ears, swelling, back pain, or numbness
  • ✓Stop use immediately and consult a doctor, pharmacist, or registered salesperson if you experience excessive decrease in body temperature, extreme weakness, or cold hands and feet after taking this product.
  • ✓Stop use and consult a doctor, pharmacist, or registered salesperson if the following symptoms persist or worsen: constipation, dry mouth, or drowsiness.
  • ✓Stop use and consult a doctor, pharmacist, or registered salesperson if symptoms do not improve after 5 to 6 doses — especially if fever persists for 3 or more days or keeps recurring.

Abuse-Prevention Designated Medicine 指定濫用防止医薬品

  • Purchase is limited to 1 unit per person per transaction, both in-store and online
  • A pharmacist or registered salesperson must confirm appropriate use before the sale is completed
  • Additional restrictions apply for buyers under 18
  • Do not exceed the prescribed dose — taking more than directed may cause serious adverse effects

Sources & Documents

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For informational purposes only. Always consult a doctor or pharmacist before taking any medication.