**Product Overview**Manufacturer: KowaProduct Name: Kowa Corgen IB Tablets TXα 45 TabletsDrug Classification: Designated Class 2 OTC DrugCategory: OTC MedicinePediatric Use Category: For Adults (only adult dosage and usage instructions are available)Dosage Form: Tablets, Round Tablets, CapsulesContents: 45 TabletsProduct Description: For sore throat colds and severe fever colds**[Expiration Date]**At the time of shipment, the expiration date is at least one year away.**JAN Code:** 4987067254408**Product Code:** 050410969
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**Initial Package Insert Creation Date and Revision Date, Version Number**Initial creation: October 2017Revisions: NoneVersion: E7KPlease read this package insert carefully before use and keep it in a safe place.
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**Features**This medication is a comprehensive cold remedy containing 600 mg of the antipyretic and analgesic ingredient "Ibuprofen" (daily dose).It is effective against sore throat colds and severe fever colds.When taken, seven active ingredients, including the anti-inflammatory component "Tranexamic Acid" and expectorant "Ambroxol Hydrochloride," work effectively to alleviate various severe cold symptoms, making you feel better and more comfortable.
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**Do Not Do the Following**(Doing so may worsen current symptoms or increase the risk of side effects or accidents)
1. Do not take if you are:- (1) Someone who has had allergic reactions to this medication or its ingredients.- (2) Someone who has experienced asthma after taking this or other cold or pain relief medicines.- (3) Children under 15 years old.- (4) Someone undergoing treatment or medication for the following conditions at a medical facility:- Stomach or duodenal ulcers, blood disorders, liver disease, kidney disease, heart disease, hypertension, or currently taking Zidovudine (Retrovir).- (5) Pregnant women within 12 weeks of expected delivery.
2. Do not use other medications containing:- Other cold remedies, antipyretics, sedatives, cough suppressants or expectorants, antihistamines (including nasal allergy medications, motion sickness drugs, allergy medications), or oral tranexamic acid while taking this medication.
3. Do not operate vehicles or machinery after taking this medication (drowsiness or other effects may occur).
4. Breastfeeding women should not take this medication or should avoid breastfeeding during use.
5. Do not consume alcohol before or after taking this medication.
6. Do not take for more than 5 days.
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**Consultation Before Use**1. Consult a doctor, pharmacist, or registered seller before taking if you are:- (1) Under medical or dental treatment.- (2) Pregnant or suspect pregnancy.- (3) Elderly.- (4) Have experienced allergic reactions to medicines or other substances.- (5) Have symptoms such as high fever or difficulty urinating.- (6) Diagnosed with: thyroid dysfunction, diabetes, glaucoma, systemic lupus erythematosus, mixed connective tissue disease, blood clots (cerebral thrombosis, myocardial infarction, thrombophlebitis), risk of thrombosis, asthma, respiratory impairment, obstructive sleep apnea syndrome, obesity.- (7) Have had: stomach or duodenal ulcers, ulcerative colitis, Crohn’s disease, blood disorders, liver disease, kidney disease.
2. If any of the following symptoms appear after taking, stop immediately and consult a healthcare professional with this package insert:- [Related areas] [Symptoms]- Skin: Rash, redness, itching- Digestive system: Nausea, vomiting, loss of appetite, stomach discomfort, stomach pain, stomatitis, heartburn, indigestion, gastrointestinal bleeding, abdominal pain, diarrhea, bloating- Nervous system: Dizziness, insomnia, mood depression- Circulatory system: Palpitations- Respiratory system: Shortness of breath- Urinary system: Difficult urination- Others: Blurred vision, tinnitus, swelling, back pain, numbness
Serious adverse reactions may occur rarely. In such cases, seek medical attention immediately.- **Anaphylactic Shock (Anaphylaxis):** Symptoms appear immediately after taking, including itching, hives, hoarseness, sneezing, throat itching, difficulty breathing, palpitations, altered consciousness.- **Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis:** High fever, eye redness, eye discharge, lip sores, sore throat, widespread rash or redness that persists or worsens rapidly.- **Liver Dysfunction:** Fever, itching, rash, jaundice (yellowing of skin and eyes), dark urine, fatigue, loss of appetite.- **Kidney Damage:** Fever, rash, decreased urine output, swelling, fatigue, joint pain, diarrhea.- **Aseptic Meningitis:** Severe headache with neck stiffness, fever, nausea, vomiting (more common in those treated for systemic lupus erythematosus or mixed connective tissue disease).- **Interstitial Pneumonia:** Shortness of breath, difficulty breathing, cough, fever that appears suddenly or persists.- **Asthma:** Wheezing, whistling sounds, difficulty breathing.- **Blood Disorders:** Sore throat, fever, general fatigue, pallor, bleeding tendencies (gum bleeding, nosebleeds), bruising.- **Gastrointestinal Disorders:** Black stool, vomiting blood, bloody stool, mucus or pus in stool.- **Respiratory Depression:** Shortness of breath, difficulty breathing.
3. If symptoms such as excessive lowering of body temperature, collapse, cold extremities appear, stop use immediately and consult a healthcare professional with this package insert.
4. If symptoms such as constipation, dry mouth, drowsiness occur or worsen, stop use and consult a healthcare professional.
5. If symptoms do not improve after 5-6 days of use (especially if fever persists for more than 3 days or recurs), stop use and consult a healthcare professional.
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**Efficacy and Effects**Relieves symptoms of colds such as sore throat, fever, chills, headache, cough, phlegm, nasal discharge, nasal congestion, sneezing, joint pain, muscle pain.
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**Usage and Dosage**Take the following amount with water or warm water within 30 minutes after meals as much as possible.
- **Adults (15 years and older):**- Dose per time: 3 tablets- Frequency: 3 times a day
- **Children under 15 years:**- Do not take or administer.
**[Precautions related to usage and dosage]**- Strictly adhere to the prescribed dosage and instructions.- How to take out tablets: Press firmly on the protrusions of the blister sheet containing the tablets with your fingertips, tear open the aluminum foil on the back, and take out the tablet. (Accidentally swallowing the blister or damaging the tablet can cause injury to the esophageal mucosa or other accidents.)
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**Ingredients and Amounts (per 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]**Silicon dioxide, Hydroxypropyl cellulose, Citric acid, Lactose, Calcium silicate, Hydroxypropyl cellulose, Carboxymethyl cellulose calcium, Magnesium stearate, Triactin, Talc, Titanium dioxide, Yellow No. 5, Carnauba wax
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**Storage and Handling Precautions**- Store in a cool, dry place away from high temperatures and direct sunlight.- Keep out of reach of children.- Do not transfer to other containers (may cause misuse or deterioration).- Be careful to prevent tearing the aluminum foil of the blister or damaging the tablets during storage or transport.- Do not use products past the expiration date printed on the box.
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**Inquiries**Please contact the store where purchased or the following:Kowa Co., Ltd. Pharmaceutical Business Division Customer Consultation CenterAddress: 3-4-14 Nihonbashi Honcho, Chuo-ku, Tokyo 103-8433Phone: 03-3279-7755Hours: Monday to Friday (excluding holidays) 9:00–17:00**[Kowa Product Website]**http://hc.kowa.co.jp/otc
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**Package-specific Common JAN Code**- 27 Tablets: 4987067254309- 45 Tablets: 4987067254408
**Manufacturer:** Kowa
**Contents:** 45 Tablets × 1 bottle
**Suggested Retail Price:** 2,200 yen
**OTC Drug Classification:** Designated Class 2 OTC Drug
**Poison/Restricted Drug Category:** Not classified as poison or restricted drug
**Agricultural/Animal Drug Category:** Not classified as agricultural or veterinary drug
**Dosage Form:** Tablet
**Pediatric Use Category:** For Adults (only adult dosage and instructions available)
**Product Category:** OTC Medicine
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**Disclaimer**【Notice】- The product descriptions above, excluding price information, are provided by the manufacturer or the Self-Medication Database Center.- If you have any questions or concerns about using this medicine, consult a doctor or pharmacist.- We assume no responsibility for health damages caused by taking medicines purchased through this service.
**Self-Medication Tax Deduction**This product qualifies for the self-medication tax deduction system.