SUDAFED OM® Nasal Spray

SUDAFED OM - oxymetazoline hydrochloride spray 
McNeil Consumer Healthcare Div McNeil-PPC, Inc

----------

SUDAFED OM®
Nasal Spray

Drug Facts

Active ingredient (in each spray)

Oxymetazoline HCl 0.05%

Purpose

Nasal decongestant

Uses

Warnings

Ask a doctor before use if you have

When using this product

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 overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

adults and children 6 years to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril, not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24 hour period.

children under 6 years: do not use

Other information

Inactive ingredients

benzalkonium chloride solution, benzyl alcohol, dibasic sodium phosphate, edetate disodium, glycerin, hypromellose, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water

Questions or comments?

call 1-888-217-2117

PRINCIPAL DISPLAY PANEL

NDC 50580-528-05

SUDAFED OM®
Oxymetazoline HCl • Nasal Decongestant

SINUS
CONGESTION
MOISTURIZING NASAL SPRAY

FAST ACTING
12
HOUR
RELIEF

Fast, Effective
Relief of:

0.5 FL. OZ. (15mL)

Principal Display Panel

SUDAFED OM 
oxymetazoline hydrochloride   spray
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)50580-528
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oxymetazoline Hydrochloride (Oxymetazoline) Oxymetazoline Hydrochloride0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
benzalkonium chloride 
benzyl alcohol 
sodium phosphate, dibasic 
edetate disodium 
glycerin 
hypromelloses 
sodium phosphate, monobasic 
polyethylene glycol 
propylene glycol 
water 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
150580-528-051 BOTTLE In 1 CARTONcontains a BOTTLE, SPRAY
115 mL In 1 BOTTLE, SPRAYThis package is contained within the CARTON (50580-528-05)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/01/2008

Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)
Revised: 11/2010McNeil Consumer Healthcare Div McNeil-PPC, Inc