Stona Ivy Gel EX 24 Capsules [Designated Class 2 OTC Drug]

Product Information

Works on sore throat and fever

●A cold medicine containing ibuprofen, which is effective for cold symptoms such as sore throat, and tranexamic acid.
●Bromhexine hydrochloride thins phlegm caught in the throat.
●Easy-to-take soft capsules with liquid contents.

Deviating from the specified dosage and administration of a medicine can lead 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.

About the Sale of Medicines

●Precautions for Use
■■Things You Must Not Do■■ (If not observed, current symptoms may worsen or side effects/accidents may become more likely to occur)
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 had asthma caused by taking this medicine or other cold medicines or antipyretic analgesics.
(3) Children under 15 years.
(4) Pregnant women within 12 weeks of their expected delivery date.
(5) Persons receiving treatment for the following diseases or administration of medicines at a medical institution.
Gastric or duodenal ulcer, blood disease, liver disease, kidney disease, heart disease, high blood pressure, persons receiving zidovudine (Retrovir, etc.)
2. While taking this medicine, do not use any of the following medicines: other cold medicines, antipyretic analgesics, sedatives, antitussive and expectorants, 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 (drowsiness, etc. may occur).
4. Persons who are breastfeeding should not take this medicine, or if taking this medicine, should avoid breastfeeding
5. Do not drink alcohol before or after taking this medicine
6. Do not take 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 with the following symptoms.
High fever, difficulty urinating
(6) Persons who have received the following diagnoses or who have had the following diseases.
Gastric or duodenal ulcer, blood disease, liver disease, kidney disease, heart disease, high blood pressure, bronchial asthma, systemic lupus erythematosus, mixed connective tissue disease, ulcerative colitis, Crohn's disease, thyroid dysfunction, diabetes, glaucoma, persons with blood clots (cerebral thrombosis, myocardial infarction, thrombophlebitis), persons at risk of developing thrombosis, respiratory dysfunction, obstructive sleep apnea syndrome, obesity
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 this document with you

Relevant Area – Symptoms
Skin – Rash/redness, itching, bruising
Digestive system – Nausea/vomiting, loss of appetite, stomach discomfort, stomach pain, mouth ulcers, heartburn, heavy stomach, gastrointestinal bleeding, abdominal pain, diarrhea, bloody stools
Psychiatric/nervous system – Dizziness, insomnia, depressed mood
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, fatigue

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

Symptom Name – Symptoms
Shock (anaphylaxis) – Immediately after taking the medicine, itching of the skin, hives, hoarseness, sneezing, itching of the throat, difficulty breathing, palpitations, clouding of consciousness, etc. appear.

Oculomucocutaneous syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis – High fever, red eyes, eye discharge, sores on the lips, sore throat, widespread rash/redness of the skin, etc. persist or rapidly worsen.

Digestive tract disorder – Black stools, vomiting blood, bloody stools, mucous bloody stools (soft stools mixed with blood, mucus, and pus), etc. appear.

Liver dysfunction – Fever, itching, rash, jaundice (yellowing of the skin or the whites of the eyes), brown urine, general fatigue, loss of appetite, etc. appear.

Kidney damage – Fever, rash, decreased urine output, swelling of the whole body, general fatigue, joint pain (aching joints), diarrhea, etc. appear.

Aseptic meningitis – Severe headache accompanied by stiffness of the neck, fever, nausea/vomiting, etc. appear. (Such symptoms have been reported especially often in persons receiving treatment for systemic lupus erythematosus or mixed connective tissue disease.)

Myocardial infarction – Squeezing chest pain, difficulty breathing, cold sweats.

Cerebrovascular disorder – Decreased or lost consciousness, difficulty moving the arm and leg on one side, headache, vomiting, dizziness, difficulty speaking, difficulty getting words out, etc. appear suddenly.

Interstitial pneumonia – Shortness of breath or difficulty breathing when climbing stairs or exerting yourself slightly, dry cough, fever, etc. appear suddenly or persist.

Asthma – Wheezing or whistling sounds when breathing, difficulty breathing, etc. appear.

Aplastic anemia – Bruises, nosebleeds, bleeding from the gums, fever, pale-looking skin and mucous membranes, fatigue, palpitations, shortness of breath, feeling unwell and light-headed, blood in the urine, etc. appear.

Agranulocytosis – Sudden high fever, chills, sore throat, etc. appear.

Respiratory depression – Shortness of breath, difficulty breathing, etc. appear.

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

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



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



●Dosage and Administration
Take the following single dose after meals, within 30 minutes if possible.
Age – Single dose – Times per day
Adults (15 years and older) – 2 capsules – 3 times
Under 15 years – Do not take.

<Precautions related to dosage and administration>
(1) Strictly follow the specified dosage and administration.
(2) How to remove the capsules: Press the raised part of the PTP sheet containing the capsule firmly with your fingertip to break the aluminum foil on the back, take out the capsule, and then take it. (Accidentally swallowing the capsule still in the sheet may lead to unexpected accidents, such as the sheet piercing the mucous membrane of the esophagus.)



●Ingredients and Amounts
In 6 capsules
Ingredient – Amount – Action
Ibuprofen – 600 mg
– Suppresses fever, chills, sore throat, joint pain, headache, etc.

Tranexamic acid – 750 mg
– Suppresses inflammation through its antiplasmin action and is effective for cold symptoms such as sore throat.

Bromhexine hydrochloride – 12 mg
– Increases airway secretions and thins phlegm caught in the throat, making it easier to expel.

Dihydrocodeine phosphate – 24 mg
– Acts on the cough center and calms coughing.

dl-Methylephedrine hydrochloride – 60 mg
– Dilates the bronchi, calms coughing, and makes phlegm easier to expel.

d-Chlorpheniramine maleate – 3.5 mg
– Suppresses symptoms such as runny nose, nasal congestion, and sneezing.

Anhydrous caffeine – 75 mg
– Supports the action of the ingredients that relieve fever and pain.

Contains the following additives: polysorbate 80, sodium lauryl sulfate, glyceryl fatty acid ester, medium-chain fatty acid triglycerides, potassium hydroxide, gelatin, succinylated gelatin, glycerin, titanium oxide, carmine.



●Precautions for Storage and Handling
(1) Store in a cool place with low humidity, away from direct sunlight.
(2) Store out of the reach of children.
(3) Do not transfer to another container.
(This may cause misuse or change the quality.)
(4) Do not take the product after the expiration date.



●Contact Information
For inquiries about this product, please contact the store where you purchased it or the following.
Sato Pharmaceutical Co., Ltd. Customer Consultation Desk
Tel. 03-5412-7393
Hours: 9:00 to 17:00 (excluding Saturdays, Sundays, and public holidays)

Manufacturer and Distributor
Sato Pharmaceutical Co., Ltd.
東京都港区赤坂1丁目5番27

Contact for the Relief System for Sufferers from Adverse Drug Reactions: Pharmaceuticals and Medical Devices Agency (PMDA) Tel. 0120-149-931 (toll-free)