NEO-SYNEPHRINE  EXTRA STRENGTH- phenylephrine hydrochloride spray 
Foundation Consumer Healthcare LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Neo-Synephrine®
Extra Strength

Drug Facts

Active ingredient

Phenylephrine hydrochloride 1.0%

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

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

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

Extra Strength

Neo-
Synephrine®
Nasal Spray
Phenylephrine HCl 1.0% Nasal Decongestant

POWERFUL
RELIEF
you can
use every
4 HRS

NON-DROWSY
COLD +
ALLERGY

Nasal
Congestion
RELIEF

Pharmacist
Recommended

1/2 FL OZ (15 mL)

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
NEO-SYNEPHRINE   EXTRA STRENGTH
phenylephrine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69536-175
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Phenylephrine hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine hydrochloride1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69536-175-151 in 1 CARTON06/30/201707/01/2021
115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2NDC:69536-175-211 in 1 CARTON06/30/201709/01/2018
221 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/30/201707/01/2021
Labeler - Foundation Consumer Healthcare LLC (079675882)

Revised: 6/2020
Document Id: ebcd47ff-8612-468e-9a39-d362f7816f49
Set id: e37c23cf-88d4-4adc-994c-842c44951adc
Version: 2
Effective Time: 20200611
 
Foundation Consumer Healthcare LLC