Medication Guide App

Stonarhini

Dosage form: tablet
Ingredients: CHLORPHENIRAMINE MALEATE 2mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Sato Pharmaceutical Co., Ltd.
NDC Code: 49873-109

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

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 our 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 8 hours, not to exceed 6 tablets in 24 hours
children under 12 years of age:  ask a doctor

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

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STONARHINI 
chlorpheniramine maleate, phenylephrine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-109
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
SILICON DIOXIDE 
FD&C RED NO. 40 
HYDROXYPROPYL CELLULOSE 
MAGNESIUM STEARATE 
MANNITOL 
ALUMINUM OXIDE 
Product Characteristics
Colorred (pale red) Scoreno score
ShapeROUNDSize10mm
FlavorMENTHOLImprint CodeS10
Contains    
Packaging
#Item CodePackage Description
1NDC:49873-109-014 BLISTER PACK (BLISTER PACK) in 1 CARTON
16 TABLET (TABLET) in 1 BLISTER PACK
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/FEIOperations
Sato Pharmaceutical Co., Ltd.715699133manufacture, label, pack

Revised: 01/2012
 
Sato Pharmaceutical Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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