NEO-SYNEPHRINE COLD AND SINUS EXTRA STRENGTH- phenylephrine hydrochloride spray 
Bayer 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 ® Cold & Sinus

Extra Strength

Drug Facts

Active ingredient

Phenylephrine hydrochloride 1.0%

Purpose

Nasal decongestant

Uses

  • temporarily relieves nasal congestion:
    • due to common cold
    • due to hay fever or other upper respiratory allergies (allergic rhinitis)
  • temporarily relieves stuffy nose
  • helps clear nasal passages; shrinks swollen membranes
  • temporarily restores freer breathing through the nose
  • helps decongest sinus openings and passages;
    temporarily relieves sinus congestion and pressure

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
  • difficulty in urination due to enlargement of the prostate gland

When using this product

  • do not exceed recommended dosage
  • 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 may occur such as burning, stinging, sneezing, or an increase in nasal discharge
  • use of this container by more than one person may spread infection

Stop use and ask a doctor if symptoms persist for more than 3 days

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

  • use only as directed
  • to spray, squeeze bottle quickly and firmly
adults and children 12 years and older2 or 3 sprays in each nostril not more often than every 4 hours
children under 12 yearsask a doctor

Other information

  • store at room temperature
  • protect from light

Inactive ingredients

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

Questions or comments?

1-800-986-0369 (Mon – Fri 9AM – 5PM EST) or www.bayercare.com

Dist. by:
Bayer HealthCare LLC
Whippany, NJ 07981
Made in Germany

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

Neo-
Synephrine ®

Phenylephrine HCl 1.0%
Nasal Decongestant

COLD & SINUS
EXTRA Strength Spray

NON-DROWSY

Fast, Extra Strength
Nasal Congestion
Relief Formula

COLDS • ALLERGIES

• PHARMACIST RECOMMENDED •

1/2 FL OZ (15mL)

Principal Display Panel - 15 mL Bottle Carton
NEO-SYNEPHRINE COLD AND SINUS  EXTRA STRENGTH
phenylephrine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0935
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 (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-0935-051 in 1 CARTON07/15/201412/01/2014
115 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 finalpart34107/15/201412/01/2014
Labeler - Bayer HealthCare LLC. (112117283)
Establishment
NameAddressID/FEIBusiness Operations
Bayer HealthCare LLC Animal Health Division152266193manufacture(0280-0935) , pack(0280-0935)

Revised: 7/2017
Document Id: 54c42a4c-f94f-25d1-e054-00144ff8d46c
Set id: 0cb284b1-6fcb-4650-83a3-4c4542aeff45
Version: 2
Effective Time: 20170720
 
Bayer HealthCare LLC.