NEO-SYNEPHRINE REGULAR- phenylephrine hydrochloride spray

Neo-Synephrine Regular by

Drug Labeling and Warnings

Neo-Synephrine Regular by is a Otc medication manufactured, distributed, or labeled by BF ASCHER AND CO INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Phenylephrine hydrochloride 0.50%

PURPOSE

Nasal decongestant

INDICATIONS & 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.

WARNINGS

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.

DO NOT USE

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.

ASK DOCTOR

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.

STOP USE

Stop use and ask a doctor if symptoms persist.

PREGNANCY 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.

DOSAGE & 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

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NEO-SYNEPHRINE REGULAR 
phenylephrine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0225-0805
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0225-0805-47	15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/01/2020

Labeler - BF ASCHER AND CO INC (003854403)