Sinus Congestion Relief

Drug Facts

Composition & Product

Active Ingredients

Phenylephrine (10 mg)

Inactive Ingredients

Silicon Dioxide D&c Yellow No. 10 Aluminum Lake Fd&c Blue No. 1 Fd&c Red No. 40 Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Starch, Potato Sodium Starch Glycolate Type A Potato Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

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

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-05-30

Medication Information

Purpose

Nasal decongestant

Description

Phenylephrine HCl 10 mg

Uses

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

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • symptoms do not improve within 7 days or occur with a fever

Section 50567-7

When using this product do not exceed recommended dose

Section 50569-3

Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes

• trouble urinating due to an enlarged prostate gland

Section 50570-1

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.

Section 53414-9

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

Directions

adults & children 12 years & over	take 1 tablet every 4 hours do not take more than 6 tablets in 24 hours
children under 12 years	ask a doctor

Drug Facts

Other Information

• store between 20-25°C (68-77°F)

Inactive Ingredients

colloidal silicon dioxide, D&C yellow#10 aluminum lake, FD&C Blue#1, FD&C Red #40, hypromellose, magnesium stearate, microcrytalline cellulose, polyethylene glycol, starch, sodium starch glycolate, talc, titanium dioxide

Questions Or Comments?

1-888-333-9792

Principal Display Panel

Compare to active

ingredient in Sudafed PE®

Sinus Congestion†

NDC 82501-1577-1

Good now

Sinus Congestion Relief PE

Phenylephrine HCl Tablets, 10 mg

24 TABLETS

Nasal Decongestant

Relief of

Nasal & Sinus Congestion

Sinus Pressure

Active Ingredient (in Each Tablet)

Phenylephrine HCl 10 mg

Structured Label Content

Uses

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

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. (1-800-222-1222)

Section 50566-9 (50566-9)

Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • symptoms do not improve within 7 days or occur with a fever

Section 50567-7 (50567-7)

When using this product do not exceed recommended dose

Section 50569-3 (50569-3)

Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes

• trouble urinating due to an enlarged prostate gland

Section 50570-1 (50570-1)

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.

Section 53414-9 (53414-9)

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

Purpose

Nasal decongestant

Directions

adults & children 12 years & over	take 1 tablet every 4 hours do not take more than 6 tablets in 24 hours
children under 12 years	ask a doctor

Drug Facts

Other Information (Other information)

• store between 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, D&C yellow#10 aluminum lake, FD&C Blue#1, FD&C Red #40, hypromellose, magnesium stearate, microcrytalline cellulose, polyethylene glycol, starch, sodium starch glycolate, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Compare to active

ingredient in Sudafed PE®

Sinus Congestion†

NDC 82501-1577-1

Good now

Sinus Congestion Relief PE

Phenylephrine HCl Tablets, 10 mg

24 TABLETS

Nasal Decongestant

Relief of

Nasal & Sinus Congestion

Sinus Pressure

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Phenylephrine HCl 10 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "• temporarily relieves sinus congestion and pressure • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)", "50566-9": "Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • symptoms do not improve within 7 days or occur with a fever", "50567-7": "When using this product do not exceed recommended dose", "50569-3": "Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland", "50570-1": "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.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Nasal decongestant", "Directions": "adults & children 12 years & 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": "• store between 20-25°C (68-77°F)", "Inactive ingredients": "colloidal silicon dioxide, D&C yellow#10 aluminum lake, FD&C Blue#1, FD&C Red #40, hypromellose, magnesium stearate, microcrytalline cellulose, polyethylene glycol, starch, sodium starch glycolate, talc, titanium dioxide", "Questions or comments?": "1-888-333-9792", "PRINCIPAL DISPLAY PANEL": "Compare to active ingredient in Sudafed PE® Sinus Congestion† NDC 82501-1577-1 Good now Sinus Congestion Relief PE Phenylephrine HCl Tablets, 10 mg 24 TABLETS Nasal Decongestant Relief of Nasal & Sinus Congestion Sinus Pressure", "Active Ingredient (in each tablet)": "Phenylephrine HCl 10 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information