STONARHINI (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE) TABLET [SATO PHARMACEUTICAL CO., LTD.]

  • Home
  • STONARHINI (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE) TABLET [SATO PHARMACEUTICAL CO., LTD.]

STONARHINI (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE) TABLET [SATO PHARMACEUTICAL CO., LTD.]
PDF | XML
NDC 49873-109-01
Set ID cc353280-0b4c-418c-93fe-850125955009
Category HUMAN OTC DRUG LABEL
Packager Sato Pharmaceutical Co., Ltd.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
View All Sections
  • ACTIVE INGREDIENT

    Active ingredients (In each tablet)        
    Chlorpheniramine Maleate 2 mg    
    Phenylephrine HCl 5 mg

  • PURPOSE

    Purpose
    Chlorpheniramine Maleate    Antihistamine
    Phenylephrine HCl        Nasal decongestant

  • INDICATIONS & USAGE

    Uses
    Temporarily relieves these symptoms due to common cold, hay fever or other upper respiratory allergies (allergic rhinitis).
    ■ sneezing        ■ runny nose    ■ itchy, watery eyes
    ■ nasal congestion, stuffy nose        ■ itchy throat

  • Warnings​

    Enter section text here

    Do not use this product
    ■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease) or for 2 weeks after stopping the MAOI drug.  If you do not know if your prescription contains an MAOI, ask a doctor or pharmacist before taking this priduct.

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

    Ask a doctor or pharmacist before use
    ■ if you are taking sedatives or tranquilizers

    When using this product
    ■ do not exceed recommended dosage.  If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor.
    ■ you may get drowsy.
    ■ may cause excitability, especially in children.
    ■ alcohol, sedatives and tranquilizers may increase the drowsiness effect.
    ■ avoid alcoholic beverages.
    ■ use caution when driving a motor vehicle or operating machinery.

    Stop use and ask a doctor if
    ■ symptoms do not improve within seven days
    ■ symptoms are accompanied by fever

  • PREGNANCY OR BREAST FEEDING

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

  • 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 attention is critical even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions
    adults and children 12 years and over:  2 tablets every 4 hours, not to exceed 12 tablets in 24 hours
    children under 12 years of age:  ask a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients  aspartame, colloidal silicone dioxide, FD&C Red No. 40 aluminum Lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol.

  • PRINCIPAL DISPLAY PANEL

    CARTON

  • INGREDIENTS AND APPEARANCE
    STONARHINI 
    chlorpheniramine maleate, phenylephrine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-109
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROXYPROPYL CELLULOSE (TYPE EL) (UNII: 8VAB711C5E)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    Colorred (pale red) Scoreno score
    ShapeROUNDSize10mm
    FlavorMENTHOLImprint Code S10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49873-109-014 in 1 CARTON11/16/2001
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/16/2001
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-109) , label(49873-109) , pack(49873-109)
View All Sections

Related Drugs

Search DailyMed Drugs