Estac EX Neo

Estac EX Neo

エスタックEXネオ

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

Multi-symptom cold relief (ibuprofen-based)

Form

Tablets 36 tablets

Indication

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

Active Ingredients (per 6 tablets (daily dose))

Ibuprofen 600 mg
Isopropamide iodide 6 mg
Chlorpheniramine maleate 7.5 mg
Ambroxol hydrochloride 45 mg
Dihydrocodeine phosphate 24 mg
dl-Methylephedrine hydrochloride 60 mg
Magnesium oxide 300 mg
Anhydrous caffeine 75 mg

Inactive Ingredients

Anhydrous silicic acid, cellulose, lactose, hydroxypropylcellulose, hypromellose, crospovidone, macrogol, D-mannitol, magnesium stearate, talc, titanium oxide, corn starch, polyvinyl alcohol-acrylic acid-methyl methacrylate copolymer

Instructions for Use

  • Take within 30 minutes after meals with water or lukewarm water.
Age Dose per use Times per day
Adults (15 years and older) 2 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:
  • (1) You have ever had an allergic reaction to this product or any of its ingredients.
  • (2) You have ever experienced asthma after taking this product, another cold medicine, or a pain reliever/fever reducer.
  • (3) The person is under 15 years of age.
  • (4) You are within 12 weeks of your expected delivery date.
  • (5) You are currently being treated at a medical institution for gastric or duodenal ulcer, a blood disorder, liver disease, kidney disease, heart disease, or high blood pressure, or are receiving zidovudine (e.g., Retrovir).
  • Do not use any of the following medicines while taking this product: other cold medicines, pain relievers/fever reducers, sedatives, cough and phlegm medicines, or oral medicines containing antihistamines (such as medicines for rhinitis, motion sickness, allergy, or sleep aids), or stomach cramp medicines.
  • Do not drive or operate machinery after taking this product (drowsiness, blurred vision, or abnormal glare/light sensitivity may occur).
  • If you are breastfeeding, do not take this product. If you must take this product, avoid breastfeeding.
  • Do not drink alcohol before or after taking this product.
  • Do not use for more than 5 days.
  • Do not take more than 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. (This symptom has been reported more frequently in patients being treated for systemic lupus erythematosus or mixed connective tissue disease.)
  • • Myocardial infarction: Squeezing chest pain, difficulty breathing, or cold sweats.
  • • Cerebrovascular disorder (such as stroke): Decreased or loss of consciousness, weakness or inability to move one side of the body, headache, vomiting, dizziness, difficulty speaking, or inability to find words.
  • • Interstitial pneumonia: Shortness of breath with climbing stairs or slight exertion, dry cough, fever, or other symptoms that appear suddenly or persist.
  • • Asthma: Wheezing or whistling breath sounds, or difficulty breathing.
  • • Blood disorders: Sore throat, fever, general fatigue, pallor of the face or inner eyelids, tendency to bleed (such as bleeding gums or nosebleed), or bruising that does not fade with pressure.
  • • Gastrointestinal disorders: Black stool, vomiting blood, bloody stool, or mucous bloody stool (soft stool mixed with blood, mucus, and pus).
  • • 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 disease, diabetes, glaucoma, systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), bronchial asthma, respiratory dysfunction, obstructive sleep apnea syndrome, or obesity.
  • (7) Have a history of gastric or duodenal ulcer, ulcerative colitis, Crohn's disease, a 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 or redness, itching
  • Gastrointestinal: Nausea/vomiting, loss of appetite, stomach discomfort, stomach pain, mouth sores, heartburn, bloating, gastrointestinal bleeding, abdominal pain, diarrhea, or stomach/abdominal bloating
  • Nervous system: Dizziness, insomnia, low mood, or headache
  • Cardiovascular: Palpitations
  • Respiratory: Shortness of breath
  • Urinary: Difficulty urinating
  • Other: Blurred vision, ringing in the ears, swelling, numbness, back pain, excessive drop in body temperature, facial flushing, or abnormal glare/light sensitivity
  • 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 — bringing this package insert with you — if symptoms do not improve after 5 to 6 doses, especially if fever persists for 3 or more days or recurs.

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.