d208cb6f-e142-4aa3-959b-e6b601df76c1

SPL v1

SPL

SPL Set ID d208cb6f-e142-4aa3-959b-e6b601df76c1

Route

oral

Published

Effective Date 2025-03-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

phenylephrine (10 mg)

Inactive Ingredients

croscarmellose sodium silicon dioxide dicalcium phosphate fd&c red no. 40 magnesium stearate microcrystalline cellulose

Identifiers & Packaging

Pill Appearance

Imprint: S08 Shape: round Color: red Size: 7 mm Score: 1

Marketing Status

otc monograph drug active Since 2025-03-01

Purpose

Nasal decongestant

Description

Phenylephrine HCl 10mg

Medication Information

Warnings

Do not use ifyou 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.

Active Ingredient

Phenylephrine HCl 10mg

Uses

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

Purpose

Nasal decongestant

Directions

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

Other Information

each tablet contains:phosphorus 10 mg
store between 20°-25°C (68°-77°F)
protect from excessive moisture
DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive Ingredients

Crosscarmellose Soidum, Colloidal Silicon Dioxide, Dicalcium Phosphate, FD&C Red 40, Magnesium Stearate, Microcrystalline Cellulose

Description

Phenylephrine HCl 10mg

Questions?

call toll free 1-844-912-4012

Section 42229-5

Distributed by:

BI-MART

Eugene, OR 97402

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800 222-1222) right away.

Section 50567-7

When using this product do not exceed recommended dose.

Section 53414-9

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

Stop Use and Ask A Doctor If

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

Principal Display Panel 36 Count

NDC 37835-651-36

Compare to the active ingredients in Sudafed PE® Sinus Congestion*

NON-DROWSY

NASAL DECONGESTANT PE

Phenylephrine HCl 10 mg

Relieves: Nasal & Sinus Congestion & Sinus Pressure

36 Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Sudafed PE ^®Sinus Congestion.

Principal Display Panel 100 Count

NDC 37835-651-01

Compare to the active ingredients in Sudafed PE® Sinus Congestion*

NON-DROWSY

NASAL DECONGESTANT PE

Phenylephrine HCl 10 mg

Relieves: Nasal & Sinus Congestion & Sinus Pressure

100 Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Sudafed PE ^®Sinus Congestion.

Ask A Doctor Before Use If You Have

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

Structured Label Content

Warnings

Active Ingredient (Active Ingredient (in each tablet))

Phenylephrine HCl 10mg

Uses

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

Purpose

Nasal decongestant

Directions

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

Other Information

each tablet contains:phosphorus 10 mg
store between 20°-25°C (68°-77°F)
protect from excessive moisture
DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive Ingredients

Crosscarmellose Soidum, Colloidal Silicon Dioxide, Dicalcium Phosphate, FD&C Red 40, Magnesium Stearate, Microcrystalline Cellulose

Questions?

call toll free 1-844-912-4012

Section 42229-5 (42229-5)

Distributed by:

BI-MART

Eugene, OR 97402

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800 222-1222) right away.

Section 50567-7 (50567-7)

When using this product do not exceed recommended dose.

Section 53414-9 (53414-9)

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

Principal Display Panel 36 Count (PRINCIPAL DISPLAY PANEL-36 Count)

NDC 37835-651-36

Compare to the active ingredients in Sudafed PE® Sinus Congestion*

NON-DROWSY

NASAL DECONGESTANT PE

Phenylephrine HCl 10 mg

Relieves: Nasal & Sinus Congestion & Sinus Pressure

36 Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Sudafed PE ^®Sinus Congestion.

Principal Display Panel 100 Count (PRINCIPAL DISPLAY PANEL-100 Count)

NDC 37835-651-01

Compare to the active ingredients in Sudafed PE® Sinus Congestion*

NON-DROWSY

NASAL DECONGESTANT PE

Phenylephrine HCl 10 mg

Relieves: Nasal & Sinus Congestion & Sinus Pressure

100 Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Sudafed PE ^®Sinus Congestion.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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

Advanced Ingredient Data

[{"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DICALCIUM PHOSPHATE", "unii": "L11K75P92J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIM", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure", "42229-5": "Distributed by: BI-MART Eugene, OR 97402", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800 222-1222) right away.", "50567-7": "When using this product do not exceed recommended dose.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Nasal decongestant", "Warnings": "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.", "Directions": "adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: ask a doctor", "Questions?": "call toll free 1-844-912-4012", "Other Information": "each tablet contains: phosphorus 10 mg store between 20°-25°C (68°-77°F) protect from excessive moisture DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED", "Inactive Ingredients": "Crosscarmellose Soidum, Colloidal Silicon Dioxide, Dicalcium Phosphate, FD&C Red 40, Magnesium Stearate, Microcrystalline Cellulose", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever.", "PRINCIPAL DISPLAY PANEL-36 Count": "NDC 37835-651-36 Compare to the active ingredients in Sudafed PE® Sinus Congestion* NON-DROWSY NASAL DECONGESTANT PE Phenylephrine HCl 10 mg Relieves: Nasal & Sinus Congestion & Sinus Pressure 36 Tablets *This product is not manufactured or distributed by the owner of the registered trademark Sudafed PE ® Sinus Congestion.", "PRINCIPAL DISPLAY PANEL-100 Count": "NDC 37835-651-01 Compare to the active ingredients in Sudafed PE® Sinus Congestion* NON-DROWSY NASAL DECONGESTANT PE Phenylephrine HCl 10 mg Relieves: Nasal & Sinus Congestion & Sinus Pressure 100 Tablets *This product is not manufactured or distributed by the owner of the registered trademark Sudafed PE ® Sinus Congestion.", "Active Ingredient (in each tablet)": "Phenylephrine HCl 10mg", "Ask a doctor before use if you have": "heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:47.605125 · Updated: 2026-03-14T23:08:06.304944