Stona

Sato Pharmaceutical Co., Ltd.

DRUG FACTS

FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredients (in each tablet)
Acetaminophen 162.5 mg
Chlorpheniramine maleate 2 mg    
Dextromethorphan hydrobromide 10mg
Phenylephrine hydrochloride 5 mg

Purpose

Purposes
Acetaminophen    Pain reliever-fever reducer
Chlorpheniramine maleate    Antihistamine
Dextromethorphan hydrobromide    Cough suppressant
Phenylephrine hydrochloride    Nasal decongestant

Uses

Uses
■ temporarily relieves these symptoms due to a cold, the flu, or hay fever:
    ■ minor aches and pains  ■ headache  ■ sore throat  ■ nasal congestion
    ■ runny nose  ■ sinus congestion and pressure
    ■ cough due to minor throat and bronchial irritation
    ■ sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever
■ temporarily reduces fever   

Warnings

 Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
    ■ more than 12 tablets in 24 hours, which is the maximum daily amount for this product
    ■ with other drugs containing acetaminophen
    ■ 3 or more alcoholic drinks everyday while using this product

Do not use
■ with any other drug containing acetaminophen (prescription or nonprescription).  If    you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain   drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease).  If you do not know whether a prescription drug contains an MAOI, ask a doctor or pharmacist.
■ for 2 weeks after stopping the MAOI drug

Ask a doctor before use if you have
■ liver disease    ■ heart disease    ■ high blood pressure    ■ diabetes
■ thyroid disease    ■ glaucoma    ■ a high fever
■ difficulty in urination due to enlargement of the prostate gland
■ a breathing problem such as emphysema or chronic bronchitis
■ a persistent cough    

Ask a doctor or pharmacist before use if you are
■ taking the blood thinning drug warfarin   ■ taking sedatives or tranquilizers    

When using this product
■ do not exceed recommended dosage
■ may cause excitability especially in children  ■ do not drive or operate machinery
■ avoid alcoholic beverages
■ may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect

Stop use and ask a doctor if
■ pain, cough, or nasal congestion gets worse or lasts more than 7 days
■ sore throat persists for more than 2 days
■ nasal congestion is accompanied by fever
■ nervousness, dizziness, or sleeplessness occur
■ any of the following occurs (these could be signs of a serious condition):
    ■ fever gets worse or or lasts more than 3 days  ■ a severe sore throat
    ■ sore throat is accompanied or followed by high fever, headache, nausea or vomiting
    ■ redness or swelling is present  ■new symptoms occur
    ■ cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache

Do not give to children under 12 years of age unless directed by a doctor.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions  ■ adults and children 12 years of age and older:  2 tablets every 4hours, while symptoms persist, not to exceed 6 doses (12 tablets) in 24 hours, or as directed by a doctor
                     ■ children under 12 years of age: ask a doctor

Other information
■ keep container tightly closed
■ protect from light
■ store between 15° to 30°C (59° to 86° F)

Inactive ingredients
carboxymethylcellulose, dibasic calcium phosphate, glycerin, hypromellose, magnesium stearate, polyethylene glycol 6000, polyvinyl alcohol, sugar, titanium dioxide, and wild cherry extract.