STONARHINI- chlorpheniramine maleate, phenylephrine tablet 
Sato Pharmaceutical Co., Ltd.

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Stonarhini

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

Purpose
Chlorpheniramine Maleate    Antihistamine
Phenylephrine HCl        Nasal decongestant

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

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

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

CARTON

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 DrugM01211/16/2001
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIBusiness Operations
Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-109) , label(49873-109) , pack(49873-109)

Revised: 12/2023
Document Id: 0bde79c5-e52f-ea0b-e063-6294a90a0ab9
Set id: cc353280-0b4c-418c-93fe-850125955009
Version: 5
Effective Time: 20231206
 
Sato Pharmaceutical Co., Ltd.