VICKS SINEX  DECONGESTANT NASAL - phenylephrine hydrochloride spray 
The Procter & Gamble Manufacturing Company

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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Drug Facts

Active ingredient

Phenylephrine HCl 0.5%

Purpose

Nasal decongestant

Uses

temporarily relieves nasal congestion due to

Warnings

Ask a doctor before use if you have

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

When using this product

  • do not exceed recommended dosage
  • use of this container by more than one person may spread infection
  • temporary burning, stinging, sneezing, or increased nasal discharge may occur
  • frequent or prolonged use may cause nasal congestion to recur or worsen

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. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

adults & children 12 yrs. & older 2 or 3 sprays in each nostril without tilting your head, not more often than every 4 hours.
children 2 to under 12 yrs. ask a doctor
children under 2 yrs. do not use

Other information

Inactive ingredients

benzalkonium chloride, camphor, chlorhexidine gluconate, citric acid, disodium EDTA, eucalyptol, menthol, purified water, tyloxapol

Questions?

1-800-873-8276

www.vicks.com

Dist. by
Procter & Gamble,
Cincinnati OH 45202.
99496616

PRINCIPAL DISPLAY PANEL - 14.7 ml Bottle Carton

VICKS®

Sinex®

DECONGESTANT
NASAL SPRAY

Phenylephrine HCl...
Nasal Decongestant

Cold & Allergy Congestion

Sinus Pressure

4
HOUR
RELIEF

Fast Acting
Day/Night Relief

See Drug Facts

1/2 FL OZ (14.7 ml)

Principal Display Panel - 14.7 ml Bottle Carton

VICKS SINEX   DECONGESTANT NASAL
phenylephrine hydrochloride spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-804
Route of Administration NASAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 0.004975 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
benzalkonium chloride  
chlorhexidine gluconate  
citric acid monohydrate  
edetate disodium  
eucalyptol  
menthol  
water  
tyloxapol  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37000-804-01 1 BOTTLE, SPRAY ( BOTTLE) in 1 CARTON contains a BOTTLE, SPRAY
1 14.7 mL in 1 BOTTLE, SPRAY This package is contained within the CARTON (37000-804-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/06/2010 04/01/2011

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 06/2011 The Procter & Gamble Manufacturing Company