STONA (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [SATO PHARMACEUTICAL CO., LTD.]

STONA (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [SATO PHARMACEUTICAL CO., LTD.]
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NDC 49873-114-01
Set ID 8b89f50d-88f8-4773-92ea-5ada61766056
Category HUMAN OTC DRUG LABEL
Packager Sato Pharmaceutical Co., Ltd.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • 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

  • 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

    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    ■ 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)    

    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
    ■ 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

    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.

  • 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.

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    STONA 
    acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-114
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN162.5 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    SUCROSE (UNII: C151H8M554)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorCHERRY (WILD CHERRY EXTRACT) Imprint Code SATO;2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49873-114-011 in 1 CARTON09/29/2004
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/29/2004
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-114)

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