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

Designated Category 2 OTC medicine

ストナプラスジェルEX STONA PLUS GEL EX

Product features

● Cold medicine formulated with L-carbocysteine and bromhexine hydrochloride for high efficacy against phlegm.
● Formulated with noscapine to soothe painful cough.
● With a cream-colored soft capsule, the contents are 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 capsule : 3x
Age 12 to 14: 1 capsule: 3x
Under 12 years old: Do not take

Precautions of Dosage and Administration

(1)Strictly follow the prescribed dosage and administration.
(2)When allowing children to take the medicine, a guardian must be present to watch and tell such them how to take it.
(3)How to Dispense Capsules
 Using a finger, push the convex portion of the PTP sheet containing tablets 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
L-carbocysteine:750mg:Regulates respiratory tract secretions, reduces viscosity of phlegm,and makes expectoration easier.
Bromhexine hydrochloride:12mg:Increases respiratory tract secretions and softens phlegm in the throat, easing its expectoration.
dl-Methylephedrine hydrochloride:60mg: Effective against coughing and phlegm.
Dihydrocodeine phosphate :24mg:Effective for cough
Noscapine hydrochloride:48mg:Effective for cough
Acetaminophen:900mg: Effective against fever, chills, headache, sore throat, and joint pain.
Diphenylpyraline hydrochloride: 4mg: Effective against runny nose, stuffy nose, and sneezing.
Anhydrous caffeine:50mg:Aids the efficacy of components that reduce fever and pain..
Riboflavin:12mg:Vitamins that are easily consumed during colds
Hesperidin; 90mg; A type of vitamin P contained in citrus fruits.

<Precautions relating to ingredient and amount>
Urine may turn yellow when taking this product as it contains Riboflavin (vitamin B2).

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 12 years old.
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 a long time

■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)Those who have been diagnosed with the following.
  thyroid disease, diabetes, heart disease, hypertension, liver disease, kidney disease,gastric/duodenal ulcer, glaucoma, respiratory dysfunction, obstructive sleep apnea syndrome, 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
Gastrointestinal system: nausea and vomiting, loss of appetite,
Neuropsychiatric system:dizziness
Urinary system:urination difficulty
Other:excessive temperature decrease

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.
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
Asthma: Symptoms, such as wheezing or hissing when breathing, and difficult breathing, 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, stop taking this medicine and consult a physician, pharmacist or registered salesperson, being sure to take this instruction leaflet with you.

Additive

Polysorbate 80, glycerin fatty acid ester, propylene glycol fatty acid ester, medium chain fatty acid triglyceride, gelatin, succinated gelatin, glycerin, paraben, titanium oxide, ferric oxide

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

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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.