Stonarhini

Stonarhini
SPL v6
SPL
SPL Set ID cc353280-0b4c-418c-93fe-850125955009
Route
ORAL
Published
Effective Date 2015-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (2 mg) Phenylephrine (5 mg)
Inactive Ingredients
Aspartame Silicon Dioxide Fd&c Red No. 40 Hydroxypropyl Cellulose (type El) Magnesium Stearate Mannitol Aluminum Oxide

Identifiers & Packaging

Pill Appearance
Imprint: S10 Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2001-11-16

Description

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


Medication Information

Indications and 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

Dosage and 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

Description

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

Section 50565-1

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.

Section 50566-9

Stop use and ask a doctor if

■ symptoms do not improve within seven days

■ symptoms are accompanied by fever

Section 50567-7

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.

Section 50568-5

Ask a doctor or pharmacist before use

■ if you are taking sedatives or tranquilizers

Section 50569-3

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

Section 50570-1

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.

Section 51727-6

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

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Chlorpheniramine Maleate    Antihistamine

Phenylephrine HCl        Nasal decongestant

Section 55106-9

Active ingredients (In each tablet)        

Chlorpheniramine Maleate 2 mg    

Phenylephrine HCl 5 mg

Warnings

Enter section text here


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

■ symptoms do not improve within seven days

■ symptoms are accompanied by fever

Section 50567-7 (50567-7)

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.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use

■ if you are taking sedatives or tranquilizers

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Chlorpheniramine Maleate    Antihistamine

Phenylephrine HCl        Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (In each tablet)        

Chlorpheniramine Maleate 2 mg    

Phenylephrine HCl 5 mg

Warnings

Enter section text here


Advanced Ingredient Data


Raw Label Data

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