Colgen Kowa IB Tablets TXα 45 Tablets [Designated Class 2 OTC Drug]

Product Information

This medicine is a combination cold medicine containing 600 mg (daily dose) of the antipyretic analgesic ingredient "ibuprofen", effective for colds with a painful throat and colds with a distressing fever.
When you take this medicine, 7 highly effective active ingredients, including the anti-inflammatory ingredient "tranexamic acid" and the expectorant ingredient "ambroxol hydrochloride", work effectively to ease the distressing symptoms of a cold and make you feel better.

Deviating from the specified dosage and administration of a medicine can lead to serious harm to health. Always read the product instructions carefully before use and follow the dosage and administration. Even when a medicine is used correctly according to the dosage and administration, side effects may occur. If you notice anything unusual, stop use immediately and consult a doctor or pharmacist.

About the Sale of Medicines

●Precautions for Use
■■Things You Must Not Do■■ (If you do not follow these, your current symptoms may worsen, or side effects or accidents may be more likely to occur)
1. The following persons must not take this medicine
(1) Persons who have had allergic symptoms caused by this medicine or any of its ingredients.
(2) Persons who have had asthma after taking this medicine or other cold medicines or antipyretic analgesics.
(3) Children under 15 years.
(4) Persons receiving treatment for the following diseases or administration of medicines at a medical institution.
Gastric or duodenal ulcer, blood disease, liver disease, kidney disease, heart disease, high blood pressure, persons receiving zidovudine (Retrovir)
(5) Pregnant women within 12 weeks of their expected delivery date.
2. While taking this medicine, do not use any of the following medicines: other cold medicines, antipyretic analgesics, sedatives, antitussive and expectorants, oral medicines containing antihistamines, etc. (oral medicines for rhinitis, motion sickness medicines, allergy medicines, etc.), oral medicines containing tranexamic acid
3. Do not drive a vehicle or operate machinery after taking this medicine (drowsiness, etc. may occur.)
4. Persons who are breastfeeding should not take this medicine, or should avoid breastfeeding if they take it
5. Do not drink alcohol before or after taking this medicine
6. Do not take for more than 5 days
■■Things To Consult On■■
1. The following persons should consult a doctor, pharmacist, or registered salesclerk before taking this medicine
(1) Persons receiving treatment from a doctor or dentist.
(2) Persons who are pregnant or who think they may be pregnant.
(3) Elderly persons.
(4) Persons who have had allergic symptoms caused by medicines, etc.
(5) Persons with the following symptoms.
High fever, difficulty urinating
(6) Persons who have received the following diagnoses.
Thyroid dysfunction, diabetes, glaucoma, systemic lupus erythematosus, mixed connective tissue disease, persons with blood clots (cerebral thrombosis, myocardial infarction, thrombophlebitis), persons at risk of developing thrombosis, bronchial asthma, respiratory dysfunction, obstructive sleep apnea syndrome, obesity
(7) Persons who have had the following diseases.
Gastric or duodenal ulcer, ulcerative colitis, Crohn's disease, blood disease, liver disease, kidney disease
2. If any of the following symptoms appear after taking this medicine, they may be side effects. Stop taking it immediately and consult a doctor, pharmacist, or registered salesclerk, bringing this package insert with you

Relevant Area – Symptoms
Skin – Rash/redness, itching
Digestive system – Nausea/vomiting, loss of appetite, stomach discomfort, stomach pain, mouth ulcers, heartburn, heavy stomach, gastrointestinal bleeding, abdominal pain, diarrhea, bloating of the stomach/abdomen
Psychiatric/nervous system – Dizziness, insomnia, feeling depressed
Circulatory system – Palpitations
Respiratory system – Shortness of breath
Urinary system – Difficulty urinating
Other – Blurred vision, ringing in the ears, swelling, back pain, numbness

The following serious symptoms may occur rarely.
In that case, see a doctor immediately.

Symptom Name – Symptoms
Shock (anaphylaxis) – Immediately after taking the medicine, itching of the skin, hives, hoarseness, sneezing, itchy throat, difficulty breathing, palpitations, clouding of consciousness, etc. appear.

Oculomucocutaneous syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis – High fever, red eyes, eye discharge, sores on the lips, sore throat, widespread rash/redness of the skin, etc. persist or rapidly worsen.

Liver dysfunction – Fever, itching, rash, jaundice (yellowing of the skin and the whites of the eyes), brown urine, general fatigue, loss of appetite, etc. appear.

Kidney damage – Fever, rash, decreased urine output, swelling of the whole body, general fatigue, joint pain (aching joints), diarrhea, etc. appear.

Aseptic meningitis – Severe headache with stiffness of the neck, fever, nausea/vomiting, etc. appear. (These symptoms have been reported especially often in persons receiving treatment for systemic lupus erythematosus or mixed connective tissue disease.)

Myocardial infarction – Tightening chest pain, difficulty breathing, cold sweat.

Cerebrovascular disorder – Reduced or lost consciousness, difficulty moving the arm and leg on one side, headache, vomiting, dizziness, difficulty speaking, difficulty finding words, etc. appear suddenly.

Interstitial pneumonia – Shortness of breath or difficulty breathing when climbing stairs or exerting yourself a little, dry cough, fever, etc. are seen, and these appear suddenly or persist.

Asthma – Wheezing or whistling sounds when breathing, difficulty breathing, etc. appear.

Blood disorder – Sore throat, fever, general fatigue, whitish face or inner eyelids, bleeding easily (bleeding from the gums, nosebleeds, etc.), bruises (whose color does not fade when pressed), etc. appear.

Digestive tract disorder – Black stools, vomiting blood, bloody stools, mucous bloody stools (soft stools mixed with blood, mucus, and pus), etc. appear.

Respiratory depression – Shortness of breath, difficulty breathing, etc. appear.

3. If symptoms such as an excessive drop in body temperature, collapse (lack of strength), or cold extremities (cold hands and feet) appear after taking this medicine, stop taking it immediately and consult a doctor, pharmacist, or registered salesclerk, bringing this package insert with you

4. The following symptoms may appear after taking this medicine. If they persist or worsen, stop taking it and consult a doctor, pharmacist, or registered salesclerk, bringing this package insert with you
Constipation, dry mouth, drowsiness

5. If symptoms do not improve after taking this medicine 5 to 6 times (especially if fever continues for 3 days or more, or fever recurs), stop taking it and consult a doctor, pharmacist, or registered salesclerk, bringing this package insert with you



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



●Dosage and Administration
Take the following dose with water or warm water, preferably within 30 minutes after a meal.
Age – Single dose – Times per day
Adults (15 years and older) – 3 tablets – 3 times
Children under 15 years – Do not take.

<Precautions related to dosage and administration>
1. Strictly follow the dosage and administration.
2. How to remove the tablets: Press the raised part of the PTP sheet containing the tablet firmly with your fingertip to break the aluminum foil on the back, then take out the tablet and take it. (If the sheet is swallowed by mistake, it may pierce the mucous membrane of the esophagus or cause other unexpected accidents.)



●Ingredients and Amounts
In 9 tablets
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

[Additives] light anhydrous silicic acid, hypromellose, citric acid, lactose, calcium silicate, hydroxypropylcellulose, carmellose calcium, magnesium stearate, triacetin, talc, titanium oxide, Yellow No. 5, carnauba wax



●Precautions for Storage and Handling
1. Avoid high temperatures and store in a cool place with low humidity, away from direct sunlight.
2. Store out of the reach of children.
3. Do not transfer to another container. (This may cause misuse or change the quality.)
4. Take care during storage and when carrying so that the aluminum foil of the PTP sheet does not tear and the tablets inside are not damaged.
5. Do not take the product after the expiration date (shown on the outer box).



●Contact Information
Inquiries about this product: please contact the store where you purchased it or the following.
Kowa Company, Ltd. Pharmaceutical Division Customer Consultation Center
TEL 03-3279-7755 FAX 03-3279-7566
Hours: Monday to Friday (excluding public holidays) 9:00 to 17:00
●Kowa Products Website

Manufacturer and Distributor
Kowa Company, Ltd.
東京都中央区日本橋本町三丁目4-14