Neo-Synephrine Mild

Manufacturer
BF ASCHER AND CO INC
Effective date
2023-11-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:02:21

Label at a glance#

ProductNeo-Synephrine Mild
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure14 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine hydrochloride 0.25%

OTC - PURPOSE SECTION

Nasal decongestant

INDICATIONS & USAGE SECTION

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.

WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

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.

OTC - ASK DOCTOR SECTION

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.

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • to spray, squeeze bottle quickly and firmly
  • adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often then every 4 hours
  • Children under 6 years of age: ask a doctor

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Neo-Synephrine Mild StrengthNeo-Synephrine Mild Strength

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1234578Neo-Synephrine Cold & Sinus Mild 0.25 % Nasal SprayPSN3
1234576phenylephrine HCl 0.25 % Nasal SprayPSN3
1234578phenylephrine hydrochloride 2.5 MG/ML Nasal Spray [Neo-Synephrine]SBD3
1234576phenylephrine hydrochloride 2.5 MG/ML Nasal SpraySCD3
1234578Neo-Synephrine 0.25 % Nasal SpraySY3
1234578Neo-Synephrine 2.5 MG/ML Nasal SpraySY3
1234576phenylephrine hydrochloride 0.25 % Nasal SpraySY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0225-0800-47Neo-Synephrine Mild15 mL in 1 BOTTLE, SPRAYSPRAY153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0225-0800NEO-SYNEPHRINE MILD (PHENYLEPHRINE HYDROCHLORIDE) SPRAY [BF ASCHER AND CO INC]3Current NDC, Legacy NDC, 1 package rows20231117_9b8e9162-e4da-14d9-e053-2995a90a2269.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0225-0800-47ML - Milliliter0225-08005a545e41-c08d-4001-b1cf-764c14775e0a12020-08-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0225-08000225-0800-47

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neo-Synephrine MildPHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INC9b8e9162-e4da-14d9-e053-2995a90a22692023-11-16WarningsExact identifier
ndc (package): 0225-0800-47
ndc (product): 0225-0800
ndc11 (package): 00225080047
spl id: 0a49851d-972e-3326-e063-6394a90a5ad4
spl set id: 9b8e9162-e4da-14d9-e053-2995a90a2269

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.