maximum strength nasal decongestant

SPL v4

SPL

SPL Set ID 4e1621cb-5c72-4ebb-a331-e96005dffbc0

Route

oral

Published

Effective Date 2023-02-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

phenylephrine (10 mg)

Inactive Ingredients

carnauba wax silicon dioxide croscarmellose sodium d&c yellow no. 10 aluminum lake calcium phosphate fd&c blue no. 1 fd&c red no. 40 fd&c yellow no. 6 hypromelloses lactose monohydrate magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified sodium starch glycolate type a starch, potato stearic acid 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 2023-02-10

Purpose

Nasal decongestant

Description

Phenylephrine Hydrochloride 10 mg

Medication Information

Warnings

Uses

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

Purpose

Nasal decongestant

Directions

adults & children12 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

Carnauba wax*, colloidal silicon dioxide*, croscarmellose sodium*, D&C yellow#10 aluminum lake*, dicalcium phosphate*, FD&C Blue#1*, FD&C Red #40 , FD&C Yellow#6*, hypromellose, lactose*, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate*, starch*, stearic acid*, talc*, *contains one or more of these ingredients

Description

Phenylephrine Hydrochloride 10 mg

Carton

Section 42229-5

Distributed By:

Spirit Pharmaceuticals, LLC

Ronkonkoma, NY 11779

Made in India

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.

Drug Facts

Questions Or Comments?

1-888-333-9792

Active Ingredient (in Each Tablet)

Phenylephrine Hydrochloride 10 mg

Structured Label Content

Warnings

Uses

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

Purpose

Nasal decongestant

Directions

adults & children12 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 (Other information)

• store between 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

Carton

Section 42229-5 (42229-5)

Distributed By:

Spirit Pharmaceuticals, LLC

Ronkonkoma, NY 11779

Made in India

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)

Section 53414-9 (53414-9)

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

Drug Facts

Questions Or Comments? (Questions or comments?)

1-888-333-9792

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

Phenylephrine Hydrochloride 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", "42229-5": "Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779 Made in India", "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 & children12 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": "Carnauba wax*, colloidal silicon dioxide*, croscarmellose sodium*, D&C yellow#10 aluminum lake*, dicalcium phosphate*, FD&C Blue#1*, FD&C Red #40 , FD&C Yellow#6*, hypromellose, lactose*, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate*, starch*, stearic acid*, talc*, *contains one or more of these ingredients", "Questions or comments?": "1-888-333-9792", "Active Ingredient (in each tablet)": "Phenylephrine Hydrochloride 10 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:48.375851 · Updated: 2026-03-14T23:05:48.377821