Neo-synephrine Regular

SPL v2

SPL

SPL Set ID ab860c10-b8cf-3f92-e053-2a95a90a7317

Route

NASAL

Published

Effective Date 2020-07-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Phenylephrine (0.5 g)

Inactive Ingredients

Benzalkonium Chloride Water Sodium Citrate, Unspecified Form Sodium Chloride Anhydrous Citric Acid

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-07-01

Description

Phenylephrine hydrochloride 0.50%

Medication Information

Warnings and Precautions

When using this product:

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.
use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.

Indications and Usage

Temporarily relieves nasal congestion due to:

common cold
hay fever
upper respiratory allergies

Temporarily relieves sinus congestion and pressure

Shrinks swollen membranes so you can breathe more freely

Temporarily restores freer breathing through the nose.

Dosage and Administration

to spray, squeeze bottle quickly and firmly
adults and children 12 years of age and older: 2 or 3 sprays in each nostril not more often then every 4 hours
Children under 12 years of age: ask a doctor

Description

Phenylephrine hydrochloride 0.50%

Section 44425-7

Store at room temperature, 59º - 86º F (15º -30º C)
Retain carton for future reference on full labeling

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if symptoms persist.

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

Stop use and as a doctor if symptoms persist.

Section 50570-1

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Do not use more than directed.

Do not use for more than 3 days.

Section 51727-6

anhydrous citric acid, benazalkonium chloride, purified water, sodium chloride, sodium citrate

Section 51945-4

Section 53413-1

Call 1-800-324-1880, 7:30 - 4:00 Central, Monday - Friday, or visit www.bfascher.com

Section 53414-9

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

Section 55105-1

Nasal decongestant

Section 55106-9

Phenylephrine hydrochloride 0.50%

Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves nasal congestion due to:

common cold
hay fever
upper respiratory allergies

Temporarily relieves sinus congestion and pressure

Shrinks swollen membranes so you can breathe more freely

Temporarily restores freer breathing through the nose.

Dosage and Administration (34068-7)

to spray, squeeze bottle quickly and firmly
adults and children 12 years of age and older: 2 or 3 sprays in each nostril not more often then every 4 hours
Children under 12 years of age: ask a doctor

Warnings and Precautions (34071-1)

When using this product:

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.
use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.

Section 44425-7 (44425-7)

Store at room temperature, 59º - 86º F (15º -30º C)
Retain carton for future reference on full labeling

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms persist.

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

Stop use and as a doctor if symptoms persist.

Section 50570-1 (50570-1)

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Do not use more than directed.

Do not use for more than 3 days.

Section 51727-6 (51727-6)

anhydrous citric acid, benazalkonium chloride, purified water, sodium chloride, sodium citrate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Call 1-800-324-1880, 7:30 - 4:00 Central, Monday - Friday, or visit www.bfascher.com

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Nasal decongestant

Section 55106-9 (55106-9)

Phenylephrine hydrochloride 0.50%

Advanced Ingredient Data

[{"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies Temporarily relieves sinus congestion and pressure Shrinks swollen membranes so you can breathe more freely Temporarily restores freer breathing through the nose.", "34068-7": "to spray, squeeze bottle quickly and firmly adults and children 12 years of age and older: 2 or 3 sprays in each nostril not more often then every 4 hours Children under 12 years of age: ask a doctor", "34071-1": "When using this product: 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. use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.", "44425-7": "Store at room temperature, 59º - 86º F (15º -30º C) Retain carton for future reference on full labeling", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if symptoms persist.", "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 Stop use and as a doctor if symptoms persist.", "50570-1": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Do not use more than directed. Do not use for more than 3 days.", "51727-6": "anhydrous citric acid, benazalkonium chloride, purified water, sodium chloride, sodium citrate", "53413-1": "Call 1-800-324-1880, 7:30 - 4:00 Central, Monday - Friday, or visit www.bfascher.com", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Nasal decongestant", "55106-9": "Phenylephrine hydrochloride 0.50%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:22.472650 · Updated: 2026-03-14T23:01:51.692931