American Sales Company Fast Acting Nasal Spray Drug Facts

SPL v5

SPL

SPL Set ID 95b22dce-ef54-4ab5-9cc3-0e1cefa09ec5

Route

NASAL

Published

Effective Date 2024-10-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Phenylephrine (1 g)

Inactive Ingredients

Benzalkonium Chloride Benzyl Alcohol Boric Acid Sodium Borate Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-11-30

Description

Phenylephrine hydrochloride 1%

Purpose

Nasal decongestant

Medication Information

Purpose

Nasal decongestant

Description

Phenylephrine hydrochloride 1%

Uses

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

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)

Inactive Ingredients

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

Questions Or Comments?

1-800-719-9260

Principal Display Panel

CAREone^®

Compare to the active ingredient in 4-Way^®Fast Acting Nasal Spray

FAST ACTING NASAL SPRAY

Phenylephrine Hydrochloride 1% Nasal Decongestant

4hr

Relieves:

• Nasal Congestion

• Swollen Nasal Membranes

• Sinus Congestion

• Sinus Pressure

Gluten Free

1 FL OZ (30 mL)

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

Stop Use and Ask A Doctor If

symptoms persist

If Pregnant Or Breast Feeding,

ask a health professional before use.

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.

Active Ingredient (Active ingredient)

Phenylephrine hydrochloride 1%

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

Questions Or Comments? (Questions or comments?)

1-800-719-9260

Principal Display Panel

CAREone^®

Compare to the active ingredient in 4-Way^®Fast Acting Nasal Spray

FAST ACTING NASAL SPRAY

Phenylephrine Hydrochloride 1% Nasal Decongestant

4hr

Relieves:

• Nasal Congestion

• Swollen Nasal Membranes

• Sinus Congestion

• Sinus Pressure

Gluten Free

1 FL OZ (30 mL)

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

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

symptoms persist

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"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": "SODIUM BORATE", "unii": "91MBZ8H3QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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)", "Inactive ingredients": "benzalkonium chloride solution, benzyl alcohol, boric acid, purified water, sodium borate", "Questions or comments?": "1-800-719-9260", "Principal Display Panel": "CAREone ® Compare to the active ingredient in 4-Way ® Fast Acting Nasal Spray FAST ACTING NASAL SPRAY Phenylephrine Hydrochloride 1% Nasal Decongestant 4hr Relieves: • Nasal Congestion • Swollen Nasal Membranes • Sinus Congestion • Sinus Pressure Gluten Free 1 FL OZ (30 mL)", "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", "Stop use and ask a doctor if": "symptoms persist", "If pregnant or breast-feeding,": "ask a health professional before use.", "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: 2026-02-15T12:04:11.908462 · Updated: 2026-03-14T23:04:45.358873