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  5. Label Information: Stonarhini

FDA Label for Stonarhini

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS​
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - WHEN USING
    9. OTC - STOP USE
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DOSAGE & ADMINISTRATION
    13. INACTIVE INGREDIENT
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Stonarhini Product Label

The following document was submitted to the FDA by the labeler of this product Sato Pharmaceutical Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



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


Otc - 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


Otc - Do Not Use



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.


Otc - Ask Doctor



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


Otc - Ask Doctor/Pharmacist



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


Otc - When Using



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.


Otc - Stop Use



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


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 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.


Package Label.Principal Display Panel



CARTON - StonarCartV2

CARTON - StonarCartV2


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