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

Category 2 OTC medicine 

ストナファミリー STONA FAMILY

Product features

● It is a comprehensive cold remedy for families that works well for 11 cold symptoms.
● Applicable to children over 7 years old to elderly people.

Indication

Relief of cold symptoms (snot, stuffy nose, sneezing, sore throat, cough, sputum, chills (fever), fever, headache, joint pain, muscle pain)

Dosage and administration

Take the following single dose within 30 minutes after meals.


Adults (15 years and older): 2 tablets: 3 times
7-14 years old: 1 tablet: 3 times
Under 7 years old: Do not take

Precautions of Dosage and Administration

(1) Strictly follow the prescribed dosage and administration.
(2) If you want to take it to children, please take it under the guidance and supervision of their parents.
(3) Take the removed tablets as soon as possible.

Ingredient and amount

In 6 capsules
Acetaminophen: 900 mg: Effective for fever, chills caused by fever, headache, sore throat, and fever pain.
Dextromethorphan hydrobromide hydrate: 45 mg: A non-narcotic antitussive that acts on the cough center to soothe cough.
Chlorpheniramine maleate: 7.5 mg: Suppresses symptoms such as runny nose and stuffy nose.
Guaifenesin: 150 mg: Improves sputum removal

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, and 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 ( May cause drowsiness, etc.)
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) Patients who have experienced allergic symptoms associated with drugs, etc.
(4) Persons with the following symptoms:
hyperthermia, urination difficulty
(5) Those who have been diagnosed with the following.
 heart disease, 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
Respiratory: shortness of breath
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.
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.
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.

Additive

Ca hydrogen phosphate, CMC, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, Mg stearate, macrogol, lactose

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.

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.