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.

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) 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.
Related parts: Symptoms
○ Skin: rash/redness, itching
○ Gastrointestinal system: nausea/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, 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.
○ 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.
○ 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.

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 times per day]
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] When allowing children to take the medicine, a guardian must be present to watch and tell such them how to take it.
[3] Take the removed tablets as soon as possible.

Ingredient and amount

In 6 tablets
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: 150mg: Improves expectoration.

Additive

Ca hydrogen phosphate, CMC, hydroxypropyl cellulose, hypromellose, 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 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.

3

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)