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

Designated Category 2 OTC medicine

ストナメルティ小児用  STONA MELTY FOR CHILDREN

Product features

● A comprehensive cold medicine for children that dissolves quickly without water.
● Strawberry-flavored chewable tablet that children above the age of 5 can take.
● Also recommended for children who dislike taking tablets.

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

Chew or orally dissolve the following dose within 30 minutes after a meal.

<Age: single dose: number of daily doses>
Age 11 to 14: 4 tablets: 3x
Age 7 to 10: 3 tablets: 3x
Age 5 to 6: 2 tablets: 3x
Under 5 years: Do not use this product

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 remove tablets from the package.
Push the convex part of the PTP sheet containing the tablets with your fingertips to break the aluminum foil on the back, remove it and take.
(If accidentally swallowed without removing the packag, it will lead to unexpected accidents such as piercing the esophageal mucosa.)
This medication breaks easily, so use the pad of your finger rather than the nail when removing it from the PTP sheet. Additionally, aluminum foil may come off in round pieces when removing medication from the PTP sheet, so please be careful not to ingest this with the medication.
(4)This medication may crack or chip, but the efficacy remains unchanged. Be sure to consume the cracked or chipped portions as well. Also, be sure to consume the dispensed tablets as soon as possible.
(5)This medicine can be taken with water.

Ingredient and amount

In 12 tablets
Acetaminophen, 600mg: Reduces fever and alleviates pain.
d-Chlorpheniramine maleate:2.3mg: Alleviates symptoms such as sneezing , runny nose, and stuffy nose.
dl-Methylephedrine hydrochloride:40mg: Relieves cough symptoms.
Noscapine:32mg: Relieves cough symptoms.

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.
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.Do not drink alcohol before/after taking this medicine
5.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)Nursing women.
(4)The elderly
(5)Patients who have experienced allergic symptoms associated with drugs, etc.
(6)Persons with the following symptoms:
hyperthermia, urination difficulty
(7) Those who have been diagnosed with the following.
  thyroid disease, diabetes, heart disease, hypertension, liver disease, kidney disease,gastric/duodenal ulcer, glaucoma
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.
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.
Kidney disorders: Symptoms, such as fever, rash, reduced urinary volume, general oedema, general malaise, arthralgia (painful joints) and diarrhea, 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.
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.
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
※.Although this medication is for children, general precautions established for cold medication are described here.

Additive

Acesulfame K, talc, erythritol, D-mannitol, hydroxypropyl cellulose, aspartame (L-phenylalanine compound), ferric oxide, flavor (starch partial hydrolyzate, propylene glycol, glycerin, ethanol, vanillin, ethyl vanillin, l-menthol Including 2), other 2 ingredients

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.