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

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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 Type HUMAN OTC DRUG NDC Product Code (Source) 50580-528
Route of Administration NASAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Oxymetazoline Hydrochloride (Oxymetazoline) Oxymetazoline Hydrochloride 0.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
benzalkonium chloride  
benzyl alcohol  
sodium phosphate, dibasic  
edetate disodium  
glycerin  
hypromelloses  
sodium phosphate, monobasic  
polyethylene glycol  
propylene glycol  
water  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 50580-528-05 1 BOTTLE In 1 CARTON contains a BOTTLE, SPRAY
1 15 mL In 1 BOTTLE, SPRAY This package is contained within the CARTON (50580-528-05)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 07/01/2008

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