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.

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 overdose or use for extended periods
■ 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.
Related parts: Symptoms
○ Skin: rash/redness, itching
○ Gastrointestinal system: nausea/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, acute generalised exanthematous pustulosis: hyperthermia, ocular hyperaemia, eye discharge, lip erosion, pain throat, widespread skin rash/redness, small pimples (small pustules) on reddened skin, general malaise, anorexia, etc. may persist or suddenly worsen.
○ Drug-induced hypersensitivity syndrome: Symptoms such as widespread redness of the skin, generalised rash, fever, malaise, and swelling of lymph nodes (neck, armpit, groin, etc.) may occur.
○ 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.
○ 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.
○ 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 consult your physician, pharmacist, or registered salesperson.
　dry mouth, drowsiness
4. When symptoms do not improve even after taking the medicine 5 to 6 times, stop taking this medicine and consult your physician, pharmacist or registered salesperson, being sure to take this document with you.
※ Although this medication is for children, general precautions established for cold medication are described here.

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 single dose by chewing or dissolving in the mouth, preferably within 30 minutes after a meal.
[Age: Single dose: Number of times per day]
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 Dispense Tablets
Using your 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. )
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: 2.3 mg: Suppresses symptoms such as sneezing, runny nose, and nasal congestion.
dl-Methylephedrine hydrochloride: 40mg: Relieves cough symptoms.
Noscapine: 32mg: Relieves cough symptoms.

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 tightly sealed 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 take the product after its expiration date.

Customer Service Center

For inquiries about this product, please contact the store where you purchased it or the following:
Customer Service Center [Sato Pharmaceutical Co., Ltd. ]
Tel: 03-5412-7393 Reception hours: 9:00-17:00 (excluding Saturdays, Sundays, and holidays)
Telephone inquiries are only available in Japanese as a language.

Manufacturing and sales company

Sato Pharmaceutical Co., Ltd.
1-5-27 Motoakasaka, Minato-ku, Tokyo

Dosage form

Tablet

Pharmaceutical classification

Over the counter drug

Version No.

4

Contact details for the Adverse Reaction Relief System

Pharmaceuticals and Medical Devices Agency
https://www.pmda.go.jp/kenkouhigai_camp/index.html
Tel: 0120-149-931 (toll-free)