Sudafed® Om Sinus Severe No Drip Nasal Mist

Sudafed® Om Sinus Severe No Drip Nasal Mist
SPL v1
SPL
SPL Set ID 33e6239b-364a-0e62-e063-6294a90a5047
Route
NASAL
Published
Effective Date 2025-04-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (50 mg)
Inactive Ingredients
Benzyl Alcohol Carboxymethylcellulose Sodium Polyethylene Glycol, Unspecified Povidone Benzalkonium Chloride Sodium Phosphate, Dibasic Water Microcrystalline Cellulose Sodium Phosphate, Monobasic Edetate Disodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-16

Description

Drug Facts

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Drug Facts

Uses

■ temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • upper respiratory allergies

■ temporarily relieves sinus congestion and pressure

■ shrinks swollen nasal membranes so you can breathe more freely

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 51945-4

NDC 50580-364-01

NEW

SUDAFED ®OM

Oxymetazoline HCI 0.05%,

Nasal Decongestant

NO DRIP



SINUS SEVERE

  • MAXIMUM STRENGTH
  • FAST SINUS CONGESTION & PRESSURE RELIEF

COLDS & ALLERGIES

UP TO 12 HR RELIEF

NASAL MIST

1 fl oz (30 mL)



Section 53414-9



If pregnant or breast-feeding, ask a health professional before use.

Warnings

Warnings

Directions
  • adults and children 6 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 of age: ask a doctor

To Use: Shake well before use. Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Before using the first time, prime pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Secure cap after use.

How to Use:

Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Secure cap after use.

Active Ingredient

Oxymetazoline hydrochloride 0.05%

Other Information
  • store at 20-25°C (68-77°F)
  • retain carton for future reference on full labeling
Inactive Ingredients

benzalkonium chloride solution, benzyl alcohol, dibasic sodiumphosphate, edetate disodium, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, purified water

Questions Or Comments?

1-888-217-2117 (toll-free) or 215-273-8755 (collect)

When Using This Product
  • do not use more than directed
  • do not use for 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

Stop use and ask a doctor if symptoms persist

Ask A Doctor Before Use If You Have

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

Structured Label Content

Uses

■ temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • upper respiratory allergies

■ temporarily relieves sinus congestion and pressure

■ shrinks swollen nasal membranes so you can breathe more freely

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 51945-4 (51945-4)

NDC 50580-364-01

NEW

SUDAFED ®OM

Oxymetazoline HCI 0.05%,

Nasal Decongestant

NO DRIP



SINUS SEVERE

  • MAXIMUM STRENGTH
  • FAST SINUS CONGESTION & PRESSURE RELIEF

COLDS & ALLERGIES

UP TO 12 HR RELIEF

NASAL MIST

1 fl oz (30 mL)



Section 53414-9 (53414-9)



If pregnant or breast-feeding, ask a health professional before use.

Purpose

Nasal decongestant

Warnings

Warnings

Directions
  • adults and children 6 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 of age: ask a doctor

To Use: Shake well before use. Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Before using the first time, prime pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Secure cap after use.

How to Use: (How to use:)

Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Secure cap after use.

Active Ingredient (Active ingredient)

Oxymetazoline hydrochloride 0.05%

Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • retain carton for future reference on full labeling
Inactive Ingredients (Inactive ingredients)

benzalkonium chloride solution, benzyl alcohol, dibasic sodiumphosphate, edetate disodium, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, purified water

Questions Or Comments? (Questions or comments?)

1-888-217-2117 (toll-free) or 215-273-8755 (collect)

When Using This Product (When using this product)
  • do not use more than directed
  • do not use for 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 (Stop use and ask a doctor if)

Stop use and ask a doctor if symptoms persist

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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

Advanced Ingredient Data


Raw Label Data

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