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Category 2 OTC medicines

BENZA BLOCK IP PREMIUM DX JO
ベンザブロックIPプレミアムDX錠

CHARACTERISTICS

  • Two antipyretic analgesic ingredients, ibuprofen and acetaminophen, relieve sore throat and reduce fever.
  • Thiamine nitrate promotes the recovery from exhaustion caused by a cold.
  • Calcium ascorbate supplements vitamin C, which tends to be depleted when you have a cold.
  • Contains 9 ingredients to relieve various cold symptoms.
  • Easy-to-take, small, light yellowish‑brown round tablet.

USES

Relief of various cold symptoms: fever, feeling cold (chills due to fever), headache, sore throat, joint pain, runny nose, stuffy nose, muscle pain, cough, phlegm, and sneezing.

DOSAGE AND DIRECTIONS

Age One dose Daily dose
15 years or over 3 tablets 3 times
Under 15 years Do not take

Precautions regarding dosage and directions

Please follow the recommended dosage and directions.

INGREDIENTS

In 9 tablets (daily dose)

ACTIONS INGREDIENTS CONTENTS
Reduces fever and chills and relieves pain Acetaminophen 180mg
Ibuprofen 360mg
Relieves runny nose and sneezing Mequitazine 4mg
Relieves cough Dextromethorphan hydrobromide hydrate 48mg
Relieves cough and phlegm dl-Methylephedrine hydrochloride 60mg
Suppresses inflammation of the throat and relieves pain Glycyrrhizinate 39mg
Relieves headaches Anhydrous caffeine 75mg
Vitamin Thiamine nitrate 25mg
Vitamin Calcium ascorbate 500mg

Inactive ingredients:

Corn starch, maltitol syrup, tartaric acid, cellulose, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, anhydrous silicic acid, erythritol, partially hydrolyzed polyvinyl alcohol, talc, titanium oxide, red ferric oxide

PRECAUTIONS FOR USE

What you should NOT do

(If you do not follow the precautions, it may worsen your symptoms, or you may be at an increased risk of side effects and accidents.)

  1. The following persons should not take this medicine:
    1. Persons who have experienced allergic reactions to this medicine or any of its ingredients.
    2. Persons who have experienced asthma after taking this medicine or other cold medications or antipyretic analgesics.
    3. Children under 15 years of age.
    4. Pregnant women within 12 weeks of the expected delivery date.
  2. Do not use any of the following medications while you take this medicine:
    Other cold medicines, antipyretic analgesics, sedating drugs, cough and expectorant drugs, oral remedies containing an antihistamine agent (such as oral remedies for rhinitis, motion sickness drugs, medicines for allergies, and sedative hypnotics), etc.
  3. After taking this medicine, do not operate vehicles or machinery. (Drowsiness or other symptoms may occur.)
  4. Do not drink alcohol before or after taking this medicine.
  5. Do not take this medicine continuously for more than 5 days.

Who should seek consultation

  1. The following persons should consult a physician, pharmacist, or registered salesperson before taking this medicine:
    1. Persons currently receiving treatment from a physician or dentist.
    2. Women who are or may be pregnant.
    3. Breastfeeding women.
    4. Elderly persons.
    5. Persons who have experienced allergic reactions to medicines or other substances.
    6. Persons with the following symptoms: high fever, difficulty in urination.
    7. Persons diagnosed with the following conditions: Thyroid dysfunction, diabetes, heart diseases, hypertension, liver diseases, kidney diseases, glaucoma, systemic lupus erythematosus, mixed connective tissue disease.
    8. Persons who have had the following diseases: Gastroduodenal ulcer, ulcerative colitis, Crohn's disease.
  2. Stop taking this medicine immediately and consult a physician, pharmacist, or registered salesperson if the following symptoms appear after taking this medicine because they might be side effects of the medicine. Take this leaflet with you.
    Affected area Symptoms
    Skin Rashes, redness, itching, and bruising
    Digestive organs Nausea and vomiting, loss of appetite, stomach discomfort, stomach pain, stomatitis, heartburn, feeling of heaviness in the stomach, gastrointestinal bleeding, abdominal pain, diarrhea, bloody stools
    Neuropsychiatric system Dizziness
    Circulatory system Palpitation
    Respiratory system Shortness of breath, breathing difficulties
    Urinary system Difficulty in urination
    Others Blurred vision, buzzing in the ear, swelling, nose bleeding, bleeding of the gums, difficulty in stopping bleeding, bleeding, back pain, excessive body temperature decrease, heaviness of the body

    In rare cases, serious symptoms might occur. In such a case, immediately consult a physician.

    Name of symptoms Symptoms
    Shock
    (Anaphylaxis)
    Symptoms such as itching of the skin, hives, hoarseness, sneezing, itching of the throat, shortness of breath, palpitations, and clouding of consciousness occurring immediately after taking this medicine.
    Mucocutaneous ocular syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis, acute generalized exanthematous pustulosis Symptoms such as high fever, hyperemia of the eyes, eye discharge, ulceration of the lips, sore throat, rashes and redness of a large area of the skin, small rashes (small pustules) on reddened skin, heaviness of the whole body, and no appetite persist or suddenly worsen.
    Drug-induced hypersensitivity syndrome Symptoms such as widespread skin redness, generalized rash, fever, general malaise, and swelling of lymph nodes (in the neck, armpits, groin, etc.)
    Hepatic function disorder Symptoms such as fever, itching, rashes, jaundice (yellowing of the skin and white part of the eye), brown urine, heaviness of the whole body, and loss of appetite will appear.
    Renal disorder Symptoms such as fever, rashes, reduced urine output, swelling of the whole body, heaviness of the whole body, joint pain (feeling pain in the joints), and diarrhea will appear.
    Aseptic meningitis Symptoms such as severe headache with stiffness of the neck, fever, and nausea and vomitin. (These symptoms have been particularly reported in persons being treated for systemic lupus erythematosus or mixed connective tissue disease.)
    Myocardial infarction Symptoms such as crushing chest pain, shortness of breath, and cold sweats.
    Cerebrovascular disorders Symptoms such as decreased or loss of consciousness, difficulty moving one side of the body, headache, vomiting, dizziness, difficulty speaking, and difficulty finding words may suddenly occur.
    Interstitial pneumonia Shortness of breath or difficulty breathing may occur when climbing stairs or with slight exertion. Dry cough and fever may also appear, and these symptoms may occur suddenly or persist.
    Asthma Symptoms such as wheezing (whistling sounds when breathing) and difficulty breathing.
    Aplastic anemia Symptoms such as bruising, nosebleeds, bleeding gums, fever, pale appearance of the skin or mucous membranes, fatigue, palpitations, shortness of breath, feeling unwell or dizzy, and hematuria.
    Agranulocytosis Symptoms such as sudden high fever, chills, and sore throat.
    Decrease in platelets Bleeding symptoms such as nose bleed, bleeding of the gums, and bruise will appear by the decreased number of platelets, which are blood components.
  3. Stop taking this medicine and consult a physician, pharmacist. or registered sales person if the following symptoms appear after taking this medicine and continue or worsen. Take this leaflet with you.
    Constipation, dry mouth, drowsiness.
  4. Stop taking this medicine and consult a physician, pharmacist, or registered salesperson if symptoms do not improve after taking this medicine 5 to 6 times (especially if a fever persists three days or longer or repeats). Take this leaflet with you.

PRECAUTIONS FOR STORAGE AND HANDLING

  1. Store the medicine in its box in a dry, cool place away from direct sunlight.
  2. Keep out of the reach of children.
  3. To prevent improper use or loss of quality, do not transfer the medicine to another container.
  4. Once the bottle is opened, throw away the filler in the bottle. (Putting the filler back into the bottle may change the quality by absorbing moisture. The filler in the bottle protects the tablets from breakage during transportation.)
  5. Be sure to close the cap tightly after each use. (Failure to tightly close the bottle may result in loss of the quality of the medicine due to moisture.)
  6. Do not take this medicine after the expiration date.
  7. Fill in the date when the bottle was opened in the column provided on the box and bottle.
  8. Once the bottle is opened, take this medicine within about 6 months to maintain quality.