Non-drowsy Nasal Decongestant

Drug Facts

Composition & Product

Active Ingredients

Phenylephrine (10 mg)

Inactive Ingredients

Cellulose, Microcrystalline Croscarmellose Sodium Stearic Acid Polyvinyl Alcohol, Unspecified Fd&c Yellow No. 6 Fd&c Red No. 40 D&c Yellow No. 10 Dibasic Calcium Phosphate Dihydrate Magnesium Stearate Polyethylene Glycol 1000000 Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: S71 Shape: round Color: red Size: 7 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2018-02-22

Medication Information

Warnings and Precautions

*Do not use 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 drug contains an MAOI, ask a doctor or pharmacist before taking this product.

*Ask a doctor before use if you have-

heart disease
high blood pressure
diabetes
thyroid disease
trouble urinating due to an enlarged prostate gland

*When using this product do not exceed recommended dose.

*Stop use and ask a doctor if

nervousness, dizziness or sleeplessness occur
symptoms do not improve within 7 days or occur with a fever

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

*Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Indications and Usage

* temporarily relieves sinus congestion and pressure

* temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

Dosage and Administration

* take with a full glass of water

* swallow whole; do not crush, chew or dissolve

adults and children 12 years and over	1 tablet every 4 hours Do not take more than 6 tablets in 24 hours
children under 12 years	Ask a doctor

Description

Phenylephrine HCl 10mg

Section 50565-1

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6

microcrystalline cellulose, dibasic calcium phosphate, croscarmellose sodium, stearic acid, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc, FD&C yellow# 6, FD&C red #40, titanium dioxide, D&C yellow #10

Section 51945-4

Section 55105-1

Nasal Decongestant

Section 55106-9

Phenylephrine HCl 10mg

Structured Label Content

Indications and Usage (34067-9)

* temporarily relieves sinus congestion and pressure

* temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

Dosage and Administration (34068-7)

* take with a full glass of water

* swallow whole; do not crush, chew or dissolve

adults and children 12 years and over	1 tablet every 4 hours Do not take more than 6 tablets in 24 hours
children under 12 years	Ask a doctor

Warnings and Precautions (34071-1)

*Do not use 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 drug contains an MAOI, ask a doctor or pharmacist before taking this product.

*Ask a doctor before use if you have-

heart disease
high blood pressure
diabetes
thyroid disease
trouble urinating due to an enlarged prostate gland

*When using this product do not exceed recommended dose.

*Stop use and ask a doctor if

nervousness, dizziness or sleeplessness occur
symptoms do not improve within 7 days or occur with a fever

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

*Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50565-1 (50565-1)

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6 (51727-6)

microcrystalline cellulose, dibasic calcium phosphate, croscarmellose sodium, stearic acid, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc, FD&C yellow# 6, FD&C red #40, titanium dioxide, D&C yellow #10

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Nasal Decongestant

Section 55106-9 (55106-9)

Phenylephrine HCl 10mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "* temporarily relieves sinus congestion and pressure * temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies", "34068-7": "* take with a full glass of water * swallow whole; do not crush, chew or dissolve adults and children 12 years and over 1 tablet every 4 hours Do not take more than 6 tablets in 24 hours children under 12 years Ask a doctor", "34071-1": "*Do not use 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 drug contains an MAOI, ask a doctor or pharmacist before taking this product. *Ask a doctor before use if you have- heart disease high blood pressure diabetes thyroid disease trouble urinating due to an enlarged prostate gland *When using this product do not exceed recommended dose. *Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur symptoms do not improve within 7 days or occur with a fever *If pregnant or breast-feeding, ask a health professional before use. *Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "50565-1": "In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "51727-6": "microcrystalline cellulose, dibasic calcium phosphate, croscarmellose sodium, stearic acid, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc, FD&C yellow# 6, FD&C red #40, titanium dioxide, D&C yellow #10", "55105-1": "Nasal Decongestant", "55106-9": "Phenylephrine HCl 10mg"}

Non-drowsy Nasal Decongestant

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information