FDA Label for Sudafed Om Sinus Severe No Drip Nasal Mist
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- HOW TO USE:
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Sudafed Om Sinus Severe No Drip Nasal Mist Product Label
The following document was submitted to the FDA by the labeler of this product Kenvue Brands Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Active Ingredient
Oxymetazoline hydrochloride 0.05%
Purpose
Nasal decongestant
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
Warnings
Warnings
Ask A Doctor Before Use If You Have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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.
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)
How To Use:
Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Secure cap after use.
Package Label.Principal Display Panel
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 12HR RELIEF
NASAL MIST
1 fl oz (30 mL)
* Please review the disclaimer below.
