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

STONA-S (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE [SATO PHARMACEUTICAL CO., LTD.]
PDF | XML

NDC 49873-113-01
Set ID 2f4c2791-76ec-4f95-a50b-a1eb8dbc9bc1
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 capsule)    
    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 capsules 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 capsules every 4 hours, while symptoms
      persist, not to exceed 6 doses (12 capsules) 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)
    ■each capsule contains calcium 10 mg

  • INACTIVE INGREDIENT

    Inactive ingredients
    dibasic calcium phosphate, FD and C Blue No. 2 Alminum lake, FD and C Yellow No. 6, FD and C
    Yellow No. 6 Aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose,
    polysorbate 80, starch, talc, titanium dioxide, and wild cherry extract.

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    STONA-S 
    acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-113
    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
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colororange, brown (pale yellow-brown) Scoreno score
    ShapeCAPSULESize19mm
    FlavorCHERRY (WILD CHERRY EXTRACT) Imprint Code SATO;SATO
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49873-113-011 in 1 CARTON04/25/2014
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/27/2004
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-113) , label(49873-113) , pack(49873-113)

Related Drugs