Stona Gel Sinus EX 30 Capsules [Designated Class 2 OTC Drug]

Product Information

Cold medicine
Works on runny nose and nasal congestion

Stona Gel Sinus EX:
●A cold medicine containing belladonna total alkaloids and diphenylpyraline hydrochloride, which are highly effective for the runny nose of a cold.
●Acetaminophen reduces fever and relieves pain such as headache.
●Easy-to-take soft capsules with liquid contents.

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.
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.), gastrointestinal analgesic and antispasmodic medicines
3. Do not drive a vehicle or operate machinery after taking this medicine
(Symptoms such as drowsiness, blurred vision, and abnormal sensitivity to light may occur.)
4. If you are breastfeeding, do not take this medicine, or avoid breastfeeding while taking this medicine
5. Do not drink alcohol before or after taking this medicine
6. Do not use continuously for a long period
■■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.
Thyroid dysfunction, diabetes, heart disease, hypertension, liver disease, kidney disease,
Gastric/duodenal ulcer, glaucoma, 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
Digestive system – Nausea/vomiting, loss of appetite, stomach discomfort, stomach pain, abdominal pain, bloating of the stomach/abdomen, heartburn, diarrhea
Neuropsychiatric system – Dizziness, headache, numbness
Urinary system – Difficulty urinating
Other – Excessive drop in body temperature, facial flushing, abnormal sensitivity to light, swelling

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.

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.

Drug-induced hypersensitivity syndrome – Symptoms such as widespread redness of the skin, generalized rash, fever, general fatigue, and swelling of the lymph nodes (neck, armpits, groin, etc.) may occur.

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.

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.

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 this document with you
Constipation, dry mouth, drowsiness, blurred vision

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 this document with you



●Indications
Relief of the various symptoms of a cold (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 preferably within 30 minutes after meals.
Age – Single Dose – Doses per Day
Adults (15 years of age or older) – 2 capsules – 3 times
Under 15 years of age – Do not take this medicine.

<Precautions Concerning 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, then remove the capsule 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 6 capsules
Ingredient – Amount – Action
Belladonna total alkaloids – 0.6 mg
– Acts on the parasympathetic nerves to suppress runny nose.

Diphenylpyraline hydrochloride – 4 mg
– Suppresses symptoms such as runny nose, nasal congestion and sneezing.

Acetaminophen – 900 mg
– Effective for fever, chills, headache, sore throat and joint pain.

dl-Methylephedrine hydrochloride – 60 mg
– Effective for cough and phlegm.

Dihydrocodeine phosphate – 24 mg
– Relieves cough symptoms.

Noscapine – 48 mg
– Relieves cough symptoms.

Ambroxol hydrochloride – 45 mg
– Makes phlegm easier to expel.

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

Riboflavin – 12 mg
– Replenishes vitamins that tend to be lacking during a cold.

Contains as additives Na lauryl sulfate, polysorbate 80,
propylene glycol fatty acid ester, glycerin fatty acid ester, gelatin, succinylated gelatin, glycerin, D-sorbitol, titanium oxide and parabens.

<Precautions Concerning Ingredients and Amounts>
Because this medicine contains riboflavin (vitamin B2), taking it may cause the urine to turn yellow.



●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.



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

Manufacturer and Distributor
Sato Pharmaceutical Co., Ltd.
1-5-27 Moto-Akasaka, Minato-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.