Pabron Ace Pro-X Tablets 36 Tablets [Designated Class 2 OTC Drug]

Product Information

For distressing sore throat, cough, runny nose and fever

◆Pabron Ace Pro-X Tablets is a cold medicine that contains 7 active ingredients, including ibuprofen, L-carbocisteine, ambroxol hydrochloride and pseudoephedrine hydrochloride, and is effective against 11 distressing cold symptoms such as sore throat, cough, runny nose and fever.

Deviating from the specified dosage and administration of a medicine leads 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.

●Precautions for Use
■■Things You Must Not Do■■
(Failure to follow these instructions may worsen current symptoms or increase the risk of side effects or accidents)
1. The following persons must not take this medicine
(1) Persons who have had allergic symptoms caused by this medicine or its ingredients.
(2) Persons who have experienced asthma after taking this medicine or other cold medicines or antipyretic analgesics.
(3) Children under 15 years of age.
(4) Pregnant women within 12 weeks of their expected delivery date.
(5) Persons receiving treatment for the following diseases or being administered the following medicines at a medical institution.
Gastric/duodenal ulcer, blood disease, liver disease, kidney disease, heart disease, hypertension, persons being administered zidovudine (Retrovir, etc.)
(6) Persons with the following symptoms.
Difficulty urinating due to prostatic hypertrophy
(7) Persons who have received the following diagnoses.
Hypertension, heart disease, thyroid dysfunction, diabetes
2. Do not use any of the following medicines while taking this medicine
Other cold medicines, antipyretic analgesics, sedatives, antitussive and expectorant medicines, oral medicines containing antihistamines, etc. (oral medicines for rhinitis, motion sickness medicines, allergy medicines, etc.)
3. Do not drive a vehicle or operate machinery after taking this medicine
(Symptoms such as drowsiness may occur)
4. If you are breastfeeding, do not take this medicine, or avoid breastfeeding while taking this medicine
(Transfer into breast milk has been observed in animal studies)
5. Do not drink alcohol before or after taking this medicine
6. Do not take this medicine 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 who have experienced insomnia, dizziness, weakness, tremors or palpitations caused by cold medicines, antitussive and expectorant medicines, oral medicines for rhinitis, etc.
(6) Persons with the following symptoms.
High fever, difficulty urinating
(7) Persons who have received the following diagnoses or who have had these diseases.
Gastric/duodenal ulcer, blood disease, liver disease, kidney disease, bronchial asthma, systemic lupus erythematosus, mixed connective tissue disease, ulcerative colitis, Crohn's disease, glaucoma, respiratory dysfunction, obstructive sleep apnea syndrome, obesity
(8) Persons receiving treatment with a monoamine oxidase inhibitor (selegiline hydrochloride, etc.).
(Selegiline hydrochloride is used to treat Parkinson's 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 these instructions with you

Relevant Area – Symptoms
Skin – Rash/redness, itching, edema, bruising
Digestive system – Nausea/vomiting, loss of appetite, stomach discomfort, stomach pain, mouth ulcers, heartburn, stomach heaviness, gastrointestinal bleeding, abdominal pain, diarrhea, bloody stool, stomach/abdominal bloating
Neuropsychiatric system – Dizziness, numbness, insomnia, depressed mood, nervousness, convulsions
Circulatory system – Palpitations
Respiratory system – Shortness of breath
Urinary system – Difficulty urinating
Other – Blurred vision, ringing in the ears, swelling, nosebleeds, bleeding gums, bleeding that is difficult to stop, bleeding, back pain, excessive drop in body temperature, general fatigue

The following serious symptoms may occur rarely.
In such cases, see a doctor immediately.

Symptom Name – Symptoms
Shock (anaphylaxis) – Immediately after taking this medicine, symptoms such as itching of the skin, hives, hoarseness, sneezing, itchy throat, difficulty breathing, palpitations, and clouding of consciousness may occur.

Blood disorder – Symptoms such as bruising easily, sudden high fever, chills, sore throat, bleeding easily (bleeding gums, nosebleeds, etc.), and bleeding that is difficult to stop may occur.

Digestive disorder – Symptoms such as black stool, vomiting of blood, bloody stool, and mucous bloody stool (soft stool mixed with blood, mucus and pus) may occur.

Mucocutaneous ocular syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis, acute generalized exanthematous pustulosis – Symptoms such as high fever, bloodshot eyes, eye discharge, lip sores, sore throat, widespread skin rash/redness, small bumps (small pustules) appearing on reddened skin, general fatigue, and loss of appetite may persist or suddenly worsen.

Liver dysfunction – Symptoms such as fever, itching, rash, jaundice (yellowing of the skin and whites of the eyes), brown urine, general fatigue, and loss of appetite may occur.

Renal disorder – Symptoms such as fever, rash, decreased urine output, generalized swelling, general fatigue, joint pain (aching joints), and diarrhea may occur.

Aseptic meningitis – Symptoms such as severe headache accompanied by a stiff neck, fever, and nausea/vomiting may occur. (Such symptoms have been reported particularly often in persons receiving treatment for systemic lupus erythematosus or mixed connective tissue disease.)

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

Cerebrovascular disorder – Symptoms such as reduced or lost consciousness, difficulty moving the limbs on one side, headache, vomiting, dizziness, difficulty speaking, and difficulty forming words may appear suddenly.

Interstitial pneumonia – Symptoms such as shortness of breath or difficulty breathing when climbing stairs or exerting oneself slightly, dry cough, and fever may occur. These symptoms may appear suddenly or persist.

Asthma – Symptoms such as wheezing or whistling sounds when breathing and difficulty breathing may occur.

Aplastic anemia – Symptoms such as bruising, nosebleeds, bleeding gums, fever, pale-looking skin and mucous membranes, fatigue, palpitations, shortness of breath, feeling unwell with lightheadedness, and blood in the urine may occur.

Agranulocytosis – Symptoms such as sudden high fever, chills, and sore throat may occur.

Respiratory depression – Symptoms such as shortness of breath and difficulty breathing may occur.

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

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



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



●Dosage and Administration
Take the following dose with water or lukewarm water, preferably within 30 minutes after meals.
Age – Single Dose – Number of Doses
Adults (15 years of age or older) – 3 tablets – 3 times a day
Under 15 years of age – Do not take this medicine

[Note]
(1) Strictly follow the specified 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 remove the tablet and take it. (If the sheet is accidentally swallowed as is, it may lead to unexpected accidents such as piercing the esophageal mucosa)



●Ingredients and Amounts
Per 3 tablets
Ibuprofen – 200 mg
– Acts on the source of inflammation and pain to relieve sore throat and fever.

L-Carbocisteine – 250 mg
– Brings the airway mucus and mucous membranes closer to a normal state and makes phlegm easier to expel.

Ambroxol hydrochloride – 15 mg
– Activates the ciliary movement of the airway mucosa and smooths the mucosal surface, making it easier to expel phlegm, one of the causes of throat symptoms.

Dihydrocodeine phosphate – 8 mg
– Acts on the cough center to calm coughing.

Pseudoephedrine hydrochloride – 45 mg
– Suppresses congestion and swelling of the nasal mucosa through its vasoconstrictive action, improving nasal congestion.

Chlorpheniramine maleate – 2.5 mg
– Suppresses the symptoms of sneezing, runny nose and nasal congestion.

Riboflavin (vitamin B2) – 4 mg
– Replenishes vitamins that are easily depleted during a cold.

Additives: cellulose, anhydrous silicic acid, Mg aluminometasilicate, Na starch glycolate, hypromellose, Ca hydrogen phosphate, hydroxypropylcellulose, Mg stearate, talc

[Note]
Taking this medicine may cause the urine to turn yellow, but this is due to the vitamin B2 in this medicine and is no cause for concern.



●Precautions for Storage and Handling
(1) Store in a cool, dry place out of direct sunlight.
(2) Keep out of reach of children.
(3) Do not transfer to another container.
(This may result in misuse or a change in quality)
(4) Do not take this product after the expiration date.
Even within the expiration date, take this medicine within 6 months after opening.
(To maintain quality)



●Contact Information
Direct inquiries about this product to the store where you purchased it or to the contact below.
Contact: Taisho Pharmaceutical Co., Ltd. "Customer Service Office 0120-721-800"
Hours 8:30–17:00 (excluding Saturdays, Sundays, and public holidays)
※For details of the hours, check the Taisho Pharmaceutical website

Taisho Pharmaceutical Co., Ltd.
3-24-1 Takada, Toshima-ku, Tokyo

Contact for the Adverse Drug Reaction Relief System
Pharmaceuticals and Medical Devices Agency (PMDA)
Phone: 0120-149-931 (toll-free)

Translation Notice

• This product is manufactured and labeled for sale and use in Japan in accordance with Japanese laws and regulations.
• This English product information is a translation of the original Japanese product information and is provided for reference only. It does not guarantee that the product or this information conforms to the laws and regulations of any country other than Japan.
• The translation may contain errors or omissions and may be revised without notice. If there is any discrepancy between this translation and the original Japanese text, the original Japanese text takes precedence. The original is available on the Japanese version of this page.