Otc - Active Ingredient
Active ingredients (In each tablet)
Chlorpheniramine Maleate 2 mg
Phenylephrine HCl 5 mg
Stonarhini Tablet
FDA Label NDC 49873-109
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sato Pharmaceutical Co., Ltd. for the product Stonarhini (NDC 49873-109). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
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