Stona Tablet
FDA Label NDC 49873-114

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sato Pharmaceutical Co., Ltd. for the product Stona (NDC 49873-114). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

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

Otc - Purpose

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

Indications & Usage

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

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

Otc - Do Not Use

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

Otc - Ask Doctor

Ask a doctor before use if you have
■ liver disease    ■ heart disease    ■ high blood pressure    ■ diabetes
■ thyroid disease    ■ glaucoma    ■ difficulty in urination due to enlargement of the prostate gland
■ a breathing problem such as emphysema or chronic bronchitis
■ a persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)    

Otc - Ask Doctor/Pharmacist

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

Otc - When Using

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

Otc - Stop Use

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
■ 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, rash, nausea or vomiting
    ■ redness or swelling is present

    ■ new symptoms occur
    ■ cough comes back or occurs with rash or headache that lasts

General Precautions

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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.

Dosage & Administration

Directions  ■ adults and children 12 years of age and older:  2 tablets every 4 hours, 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 Safety Information

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

Inactive Ingredient

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

Package Label.Principal Display Panel

Carton (Stonatabcart V3)

Carton (Stonatabcart V3)

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