drug facts

drug facts

SPL v13

SPL

SPL Set ID a8fc41c7-4425-41b8-b1c6-eb22ac054734

Route

nasal

Published

Effective Date 2025-11-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

phenylephrine (10 mg)

Inactive Ingredients

benzalkonium chloride benzyl alcohol boric acid water sodium borate

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2010-01-01

Purpose

Nasal Decongestant

Description

Phenylephrine hydrochloride 1%

Medication Information

Uses

temporarily relieves nasal congestion due to:
- common cold
- hay fever
- upper respiratory allergies

Purpose

Nasal Decongestant

Directions

adults and children 12 years and over: 2 or 3 sprays in each nostril not more often than every 4 hours
children under 12 years: ask a doctor
Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.

Other Information

store at 20°-25°C (68°-77°F)

Inactive Ingredients

benzalkonium chloride solution, benzyl alcohol, boric acid, purified water, sodium borate

Description

Phenylephrine hydrochloride 1%

Active Ingredient

Phenylephrine hydrochloride 1%

Principal Display

4 way

Phenylephrine Hydrochloride 1%

Nasal Decongestant

Fast Acting

Fast Relief of:

Nasal Congestion
Swollen Nasal Membranes
Sinus Congestion
Sinus Pressure

Nasal Spray

1 fl oz (29.6 mL)

Additional Information

READ ALL PRODUCT INFORMATION BEFORE USING.

KEEP CARTON FOR IMPORTANT INFORMATION.

DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING

Questions Or Comments?

1-855-297-3031

When Using This Product

do not use more than directed
do not use for more than 3 days. Frequent or prolonged use may cause nasal congestion to come back or get worse.
use only as directed
temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
use of this container by more than one person may spread infection

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Ask A Doctor Before Use If You Have

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

Structured Label Content

Uses

temporarily relieves nasal congestion due to:
- common cold
- hay fever
- upper respiratory allergies

Purpose

Nasal Decongestant

Directions

adults and children 12 years and over: 2 or 3 sprays in each nostril not more often than every 4 hours
children under 12 years: ask a doctor
Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.

Other Information (Other information)

store at 20°-25°C (68°-77°F)

Inactive Ingredients (Inactive ingredients)

benzalkonium chloride solution, benzyl alcohol, boric acid, purified water, sodium borate

Active Ingredient (Active ingredient)

Phenylephrine hydrochloride 1%

Principal Display

4 way

Phenylephrine Hydrochloride 1%

Nasal Decongestant

Fast Acting

Fast Relief of:

Nasal Congestion
Swollen Nasal Membranes
Sinus Congestion
Sinus Pressure

Nasal Spray

1 fl oz (29.6 mL)

Additional Information

READ ALL PRODUCT INFORMATION BEFORE USING.

KEEP CARTON FOR IMPORTANT INFORMATION.

DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING

Questions Or Comments? (Questions or comments?)

1-855-297-3031

When Using This Product (When using this product)

do not use more than directed
do not use for more than 3 days. Frequent or prolonged use may cause nasal congestion to come back or get worse.
use only as directed
temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
use of this container by more than one person may spread infection

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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

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

Advanced Ingredient Data

[{"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BORIC ACID", "unii": "R57ZHV85D4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BORATE", "unii": "91MBZ8H3QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies", "Purpose": "Nasal Decongestant", "Directions": "adults and children 12 years and over: 2 or 3 sprays in each nostril not more often than every 4 hours children under 12 years: ask a doctor Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.", "Active ingredient": "Phenylephrine hydrochloride 1%", "Other information": "store at 20°-25°C (68°-77°F)", "Principal Display": "4 way Phenylephrine Hydrochloride 1% Nasal Decongestant Fast Acting Fast Relief of : Nasal Congestion Swollen Nasal Membranes Sinus Congestion Sinus Pressure Nasal Spray 1 fl oz (29.6 mL)", "Inactive ingredients": "benzalkonium chloride solution, benzyl alcohol, boric acid, purified water, sodium borate", "Additional Information": "READ ALL PRODUCT INFORMATION BEFORE USING. KEEP CARTON FOR IMPORTANT INFORMATION. DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING", "Questions or comments?": "1-855-297-3031", "When using this product": "do not use more than directed do not use for more than 3 days. Frequent or prolonged use may cause nasal congestion to come back or get worse. use only as directed temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur use of this container by more than one person may spread infection", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)", "Ask a doctor before use if you have": "heart disease diabetes thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:33.832455 · Updated: 2026-03-14T23:13:37.162375