STONARHINI- chlorpheniramine maleate, phenylephrine tablet

Stonarhini by

Drug Labeling and Warnings

Stonarhini by is a Otc medication manufactured, distributed, or labeled by Sato Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

STONARHINI 
chlorpheniramine maleate, phenylephrine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49873-109
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	red (pale red)	Score	no score
Shape	ROUND	Size	10mm
Flavor	MENTHOL	Imprint Code	S10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49873-109-01	4 in 1 CARTON	11/16/2001
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/16/2001

Labeler - Sato Pharmaceutical Co., Ltd. (690575642)

Establishment
Name	Address	ID/FEI	Business Operations
Sato Pharmaceutical Co., Ltd.		715699133	manufacture(49873-109) , label(49873-109) , pack(49873-109)