Caution: The following texts are translated from the Japanese original. We cannot take responsibility for ambiguity in the translation.

Designated Category 2 OTC medicine

ストナアイビージェルEX  STONA IB GEL EX

Product features

●Cold medicine formulated with tranexamic acid and ibuprofen, which is effective for various cold symptoms such as sore throat.
●Bromhexine hydrochloride helps thin phlegm in the throat.
●Made with an easy-to-swallow soft capsule that contains liquid.

Indication

Relief of various symptoms of a common cold: running nose, stuffy nose, sneezing, sore throat, cough, sputum, chills , fever, headache, joint pain, and muscle pain.

Dosage and administration

Take the following amount of medicine within 30 minutes after a meal.

<Age: single dose: number of daily doses>
Adults (over 15): 2 capsules : 3x
Under 15 years old: Do not take

Precautions of Dosage and Administration

(1)Strictly follow the prescribed dosage and administration.
(2)How to Dispense Capsules
 Using a finger, push the convex portion of the PTP sheet containing capsules to break the aluminum foil on the back.
 (Can lead to unforeseen consequences such as piercing the esophageal mucosa if mistakenly swallowed.)

Ingredient and amount

In 6 capsules
Ibuprofen:600mg:Alleviates fever, chills, sore throat, joint pain, and headache.
Tranexamic acid: 750mg: Alleviates inflammation through antiplasmin action for efficacy against symptoms of cold such as sore throat.
Bromhexine hydrochloride:12mg: Increases respiratory tract secretion and softens phlegm in the throat, easing its expectoration.
Dihydrocodeine phosphate : 24mg: Works at the heart of coughs to alleviate coughing.
dl-Methylephedrine hydrochloride:60mg:Opens up bronchial tubes to alleviate coughing and ease expectoration.
d-Chlorpheniramine maleate:3.5mg: Alleviates symptoms such as runny nose, stuffy nose, and sneezing.
Anhydrous caffeine:75mg: Aids the efficacy of components that reduce fever and pain.

Precautions

■When not to use the product
(If you do not follow these instructions, the current symptoms may worsen or adverse reactions/incidents are more likely to occur.)

1.This product should not be taken by the following persons.
(1)Those who have experienced allergic symptoms to this medication or any of its ingredients.
(2)Patients who have experienced asthma from taking this drug, other cold remedies, antipyretic analgesics.
(3)Children under 15 years old.
(4)Pregnant women who are expected to given birth within 12 weeks.
(5) A person who is receiving treatment or medication for the following illness at a medical institution.
Those who are taking stomach/duodenal ulcer, blood disease, liver disease, kidney disease, heart disease, hypertension, zidovudine (retrovir, etc.)
2.This drug should not be taken together with the following drugs:
Other cold medicines, antipyretics/analgesics, sedatives, expectorants, internal medicine, etc. containing antihistamines (internal medicine for rhinitis, medicine for motion sickness, medicine for allergies, etc.)
3.After taking this drug, do not drive a car or operate machinery (sleepiness may occur).
4.Nursing women should either not take this medicine or stop nursing while taking this medicine.
5.Do not drink alcohol before/after taking this medicine
6.Do not take this medicine for more than 5 days

■Consultation
1.The following persons should contact a physician, pharmacist, or registered salesperson for a consultation before administration.
(1)Patients undergoing medical treatment from a physician or dentist.
(2)Pregnant women or women suspected of being pregnant.
(3)The elderly.
(4)Patients who have experienced allergic symptoms associated with drugs, etc.
(5)Persons with the following symptoms:
hyperthermia, urination difficulty
(6) Person who has the following diagnosis or person who has had the disease.
Gastroduodenal ulcer, blood disease, liver disease, kidney disease, heart disease, hypertension, bronchial asthma, systemic lupus erythematosus, mixed connective tissue disease, ulcerative colitis, Crohn's disease, thyroid dysfunction, diabetes, glaucoma, thrombosis People with cerebral thrombosis, myocardial infarction, thrombophlebitis, people who may develop thrombosis, respiratory dysfunction, obstructive sleep apnea, obesity
2.If the following symptoms are observed after taking this drug, these may be adverse reactions, so immediately discontinue the use of this drug, and show this document to your physician, pharmacist, or registered salesperson for a consultation.

Skin:rash/redness, itching, bruised
Gastrointestinal system: nausea and vomiting, loss of appetite, stomach ache, feeling of discomfort in the stomach, stomatitis, heartburn, stomach heaviness, gastrointestinal bleeding,abdominal pain, diarrhea, bloody stool,
Neuropsychiatric system:dizziness, insomnia, mood swings
Cardiovascular system: palpitations
Respiratory system: shortness of breath
Urinary system: urination difficulty
Other: blurred vision, ear ringing, swelling, nose bleeds, bleeding of the gums, difficult to stop bleeding, bleeding, , back pain, excessive temperature decrease, general malaise

The following serious symptoms may occur in rare cases. In such cases, immediately seek medical aid:

<Symptom name: Symptoms>
Shock (anaphylaxis): Symptoms, such as itching of skin, urticaria, hoarseness, sneezing, itchy throat, breathing difficulties, palpitations, and clouding of consciousness may occur immediately after take.
Oculomucocutaneous syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis: Hyperthermia, ocular hyperaemia, eye discharge, lip erosion, pain throat, widespread skin rash/redness, etc. may persist or suddenly worsen.
Digestive disorders: Blackened stools, bloody stools, bloody stools, mucous stools (soft stools containing blood, mucus, pus), etc.
Hepatic function failure: Symptoms, such as fever, itching, rash, jaundice (yellowing of skin and white of eyes), brown urine, general malaise, loss of appetite, etc. may occur.
Kidney disorders: Symptoms, such as fever, rash, reduced urinary volume, general oedema, general malaise, arthralgia (painful joints) and diarrhea, etc. may occur.
Interstitial pneumonia: Shortness and/or difficulties of breath when go upstairs or overwork, sudden dry cough and/or fever and its continuance
Aseptic meningitis: Symptoms, such as severe headache with a tight sensation along the neck, fever and feeling nausea/vomiting, etc. may occur. (these symptoms are frequently reported particularly in patients under treatment for systemic lupus erythematosus or mixed connective tissue disease. )
Asthma: Symptoms, such as wheezing or hissing when breathing, and difficult breathing, etc. may occur.
Aplastic anemia: Symptoms, such as bruises, nose bleeds, bleeding gums, fever, pale appearance of skin and mucosa, fatigue, palpitations, shortness of breath, becoming dizzy from feeling sick and blood in the urine, etc. may occur.
Agranulocytosis: Symptoms, such as acute high fever, chills and sore throat, etc. may occur.
Respiratory depression: May cause shortness of breath, breathing difficulties, etc.
3.The following symptoms may be observed after taking this drug. If these symptoms persist or worsen , discontinue the use of this drug, and show this document to your physician, pharmacist, or registered salesperson for a consultation.
constipation, dry mouth, drowsiness
4.When symptoms do not improve even after taking the medicine 5 to 6 times(Especially when the fever lasts more than 3 days or the fever repeats), stop taking this medicine and consult a physician, pharmacist or registered salesperson, being sure to take this instruction leaflet with you.

Additive

Polysorbate 80, Na lauryl sulfate, Glycerin fatty acid ester, Medium chain fatty acid triglyceride, K hydroxide, Gelatin, Succinated gelatin, Glycerin, Titanium oxide, Carmine

Precautions for storage and handling

(1)Store in a cool, low humidity place away from direct sunlight.
(2)Keep out of reach of children.
(3)Do not transfer the medicine to a different container. (It may lead to misuse or alter the quality of the drug. )
(4)Do not consume products past their expiration date.

Brand Site

* Click on the logo below to go to the brand homepage.

Disclaimer on Multilingual Product Information

・This product is a pharmaceutical product approved under a Japanese law, the Law for Ensuring the Quality, Efficacy and Safety of Drugs and Medical Devices, with a view to its sale and use in Japan.

・Multilingual product information is a translation of the product labeling written in Japanese and provided for your information only. It does not warrant that its contents and the product itself conforms to laws and regulations in countries other than Japan.

・Multilingual product information is a tentative translation by Our Company, and may be modified or altered without notice.

・Our Company assumes no responsibility for any occurred problem attributable to the contents of the multilingual product information.