Neo-Synephrine Severe

Manufacturer
BF ASCHER AND CO INC
Effective date
2026-06-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
monthly-update
Hydrated at
2026-07-17 21:35:32

Label at a glance#

ProductNeo-Synephrine Severe
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 1.0%

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 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

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

benzalkonium chloride, benzyl alcohol, camphor, cellulose gum, citric acid, disodium EDTA, eucalyptol, glycerin, menthol, microcrystalline cellulose and carboxymethylcellulose sodium, povidone, sodium chloride, sodium citrate, water (purified)

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 SevereNeo Severe

Products#

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DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0225-08110225-0811-47

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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 SeverePHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INC54edaff7-d241-dc90-e063-6294a90ac64d2026-06-23WarningsExact identifier
ndc (package): 0225-0811-47
ndc (product): 0225-0811
ndc11 (package): 00225081147
spl id: 54edb0ef-b9fc-8470-e063-6394a90a5885
spl set id: 54edaff7-d241-dc90-e063-6294a90ac64d

Reported adverse events (FAERS/openFDA)#

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