NEO-SYNEPHRINE REGULAR STRENGTH- phenylephrine hydrochloride spray

Neo-Synephrine by

Drug Labeling and Warnings

Neo-Synephrine by is a Otc medication manufactured, distributed, or labeled by Foundation Consumer Healthcare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Phenylephrine hydrochloride 0.5%

Purpose

Nasal decongestant

Uses

• 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

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

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland

When using this product

• do not use more than directed
• do not use more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
• 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.

Directions

• 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 than every 4 hours
• children under 12 years of age: ask a doctor

Other information

• store at 20-25°C (68-77°F)
• retain carton for future reference on full labeling

Inactive ingredients

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

Questions or comments?

call 1-855-565-5800 weekdays 9 AM to 5 PM EST

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Dist. by:
Foundation Consumer Healthcare, LLC.
Pittsburgh, PA 15205

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

Regular Strength

Neo-
Synephrine®
Nasal Spray
Phenylephrine HCl 0.5% Nasal Decongestant

FAST
RELIEF
you can
use every
4 HRS

NON-DROWSY
COLD +
ALLERGY

Nasal
Congestion
RELIEF

Pharmacist
Recommended

1/2 FL OZ (15 mL)

INGREDIENTS AND APPEARANCE

NEO-SYNEPHRINE   REGULAR STRENGTH
phenylephrine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69536-150
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69536-150-15	1 in 1 CARTON	06/30/2017
1		15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2	NDC: 69536-150-21	1 in 1 CARTON	06/30/2017
2		21 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/30/2017

Labeler - Foundation Consumer Healthcare LLC (079675882)