**Product Overview**Manufacturer: Taisho Pharmaceutical Co., Ltd.Product Name: Pabron Ace Pro-X Tablets, 36 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, CapsulesContent Quantity: 36 TabletsProduct Description: This cold medicine contains 7 active ingredients and is effective against 11 symptoms of the common cold, including sore throat, cough, runny nose, and fever.
**Expiration Date**At the time of shipment, the product has at least one year remaining before expiration.JAN Code: 4987306053380Product Code: 079514059
**Initial and Revision Dates of the Package Insert**Initial Creation: —Revised: —Please be sure to read this instruction leaflet before use. Keep it accessible for future reference.
**Features**Pabron Ace Pro-X Tablets contain 7 active ingredients, including ibuprofen, L-carbocisteine, ambroxol hydrochloride, and pseudoephedrine hydrochloride, and are effective against 11 cold symptoms such as sore throat, cough, runny nose, and fever.
**Warnings and Precautions***(Failure to follow may worsen current symptoms or increase the risk of side effects)*1. Do not take this medication if you are:- Someone who has had allergic reactions to this drug or its ingredients.- Someone who has experienced asthma triggered by this drug or other cold or pain relief medicines.- Children under 15 years old.- Pregnant women within 12 weeks of expected delivery.- Receiving treatment or medication for conditions such as gastric or duodenal ulcers, blood disorders, liver disease, kidney disease, heart disease, hypertension, or taking drugs like zidovudine (e.g., retrovir).- Experiencing symptoms like difficulty urinating due to prostate enlargement.- Diagnosed with hypertension, heart disease, thyroid dysfunction, or diabetes.
2. While taking this medication, do not use other medicines containing:- Other cold medicines, antipyretic analgesics, sedatives, cough suppressants, expectorants, antihistamines (including oral allergy medications, motion sickness drugs, etc.).
3. Do not operate vehicles or machinery after taking this medication (drowsiness or dizziness may occur).
4. If breastfeeding, do not take this medication or avoid breastfeeding during treatment (animal tests show transfer into breast milk).
5. Do not consume alcohol before or after taking the medication.
6. Do not use for more than 5 days continuously.
**Consultation Before Use**1. Consult a doctor, pharmacist, or registered seller before use if you are:- Under medical or dental treatment.- Pregnant or suspect pregnancy.- Elderly.- Have experienced allergic reactions to medicines.- Have experienced side effects like insomnia, dizziness, weakness, tremors, or palpitations from cold medicines, cough suppressants, or nasal medications.- Have symptoms such as high fever or difficulty urinating.- Diagnosed with or have had conditions like gastric/duodenal ulcers, blood disorders, liver or kidney disease, bronchial asthma, systemic lupus erythematosus, mixed connective tissue disease, ulcerative colitis, Crohn’s disease, glaucoma, respiratory impairment, obstructive sleep apnea, or obesity.- Under treatment with monoamine oxidase inhibitors (e.g., selegiline hydrochloride, used for Parkinson’s disease).
2. If any of the following symptoms appear after taking the medication, stop immediately and consult a healthcare professional:- Skin: Rash, redness, itching, swelling, bruising.- Digestive system: Nausea, vomiting, loss of appetite, stomach discomfort, stomach pain, stomatitis, heartburn, indigestion, gastrointestinal bleeding, abdominal pain, diarrhea, bloody stool, bloating.- Nervous system: Dizziness, numbness, insomnia, mood depression, nervousness, seizures.- Circulatory system: Palpitations.- Respiratory system: Shortness of breath.- Urinary system: Difficult urination.- Others: Blurred vision, tinnitus, swelling, nosebleed, gum bleeding, bleeding that is hard to stop, bleeding, back pain, excessive hypothermia, fatigue.
In rare cases, severe symptoms such as the following may occur. Seek immediate medical attention:- **Shock (Anaphylaxis):** Symptoms include itching, hives, hoarseness, sneezing, throat itching, difficulty breathing, palpitations, altered consciousness immediately after taking the drug.- **Blood Disorders:** Easy bruising, sudden high fever, chills, sore throat, bleeding tendencies (gum bleeding, nosebleeds), difficulty stopping bleeding.- **Gastrointestinal Disorders:** Black stools, vomiting blood, bloody or mucus-containing diarrhea.- **Serious Skin Reactions:** Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis. Symptoms include high fever, conjunctival redness, eye discharge, lip sores, sore throat, widespread rash and redness, small pustules on red skin, fatigue, loss of appetite.- **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. Common in patients treated for systemic lupus erythematosus or mixed connective tissue disease.- **Interstitial Pneumonia:** Shortness of breath or difficulty breathing when climbing stairs or exerting, cough, fever, sudden or persistent symptoms.- **Asthma:** Wheezing, whistling sounds, difficulty breathing.- **Aplastic Anemia:** Bruising, nosebleeds, gum bleeding, fever, pallor, fatigue, palpitations, shortness of breath, dizziness, hematuria.- **Agranulocytosis:** Sudden high fever, chills, sore throat.- **Respiratory Depression:** Shortness of breath, difficulty breathing.
3. If any of the following symptoms persist or worsen, stop taking the medication and consult a healthcare professional:- Constipation, dry mouth, drowsiness.
4. If symptoms do not improve after 5-6 days of use, discontinue and consult a healthcare professional (especially if fever persists for 3 days or recurs).
**Efficacy and Effects**Relieves symptoms of the common cold such as sore throat, cough, phlegm, runny nose, nasal congestion, sneezing, fever, chills, headache, joint pain, and muscle pain.
**Usage and Dosage**Take the following amount with water or lukewarm water within 30 minutes after meals:- Adults (15 years and older): 3 tablets per dose, 3 times daily.- Under 15 years: Do not use.
**Note:**- Strictly adhere to the prescribed usage and dosage.- How to take tablets:Press the protruding part of the PTP sheet with your fingertips to break the aluminum foil on the back, then take out the tablet. Do not swallow the tablet directly without breaking, as it may cause injury to the esophageal mucosa or other accidents.
**Ingredients and Amounts (per 3 tablets)**- Ibuprofen 200 mg: Acts on inflammation and pain, relieves sore throat and fever.- L-Carbocisteine 250 mg: Normalizes airway mucus and mucous membranes, making phlegm easier to expel.- Ambroxol Hydrochloride 15 mg: Activates ciliary movement in airway mucosa, smooths mucous surface, facilitating phlegm expulsion.- Dihydrocodeine Phosphate 8 mg: Acts on the central cough center to suppress cough.- Pseudoephedrine Hydrochloride 45 mg: Vasoconstrictive effect reduces nasal congestion and swelling.- Chlorpheniramine Maleate 2.5 mg: Suppresses sneezing, runny nose, and nasal congestion.- Riboflavin (Vitamin B2) 4 mg: Supplements vitamins that are easily depleted during a cold.
Additives: Cellulose, anhydrous silica, magnesium metasilicate, sodium glycyrrhizinate, hypromellose, calcium hydrogen phosphate, hydroxypropyl cellulose, magnesium stearate, talc.
**Note:**The medication may cause urine to turn yellow due to vitamin B2, which is normal and not a cause for concern.
**Storage and Handling Precautions**- Store in a cool, dry place away from direct sunlight.- Keep out of reach of children.- Do not transfer to other containers to prevent misuse or quality deterioration.- Do not use after the expiration date. Once opened, use within 6 months for quality preservation.
**Contact Information**For inquiries about this product, please contact the store where purchased or the following:Taisho Pharmaceutical Co., Ltd. Customer Service 119Address: 3-24-1 Takada, Toshima-ku, TokyoPhone: 03-3985-1800 (9:30 AM – 5:00 PM, excluding weekends and holidays)For adverse reaction relief system inquiries:Phone: 0120-149-931 (Toll-free)[PMDA (Pharmaceuticals and Medical Devices Agency)](https://www.pmda.go.jp/kenkouhigai_camp/index.html)
Taisho Pharmaceutical Co., Ltd. Product Information Site:https://brand.taisho.co.jp/pabron/
**Manufacturer**Taisho Pharmaceutical Co., Ltd.
**Content Quantity**36 Tablets
**Suggested Retail Price**2,178 yen (tax included)
**OTC Drug Classification**Designated Class 2 OTC Drug
**Poison and Quasi-Drug Category**Not classified as poison or quasi-drug
**Agricultural and Veterinary Drug Category**Not classified as agricultural or veterinary drug
**Dosage Form Category**Tablet
**Pediatric Use Category**For Adults only (adult dosage and instructions only)
**Product Category**OTC Medicine
**Disclaimer**【Caution】- The above product description excludes price information and is 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**Eligible for self-medication tax deduction.
| Product # | PH079514059 |
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