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Drug Facts
Sudafed Om Sinus Severe Original Spray
FDA Label NDC 50580-787
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Sudafed Om Sinus Severe Original (NDC 50580-787). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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
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: Push firmly down on cap and turn counter clockwise. To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. 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 sodium phosphate, edetate disodium, monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified water
Questions Or Comments?
call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)
Principal Display Panel
NEW
NDC 50580-787-01
SUDAFED
®OM
Oxymetazoline HCI 0.05%,
Nasal Decongestant
SINUS SEVERE
ORIGINAL
Nasal Spray
Fast, powerful congestion relief
due to colds or allergies
UP TO 12 HR RELIEF
MAXIMUM STRENGTH
1 fl oz (30 mL)
Sudafed-1 (Sudafed 1)
* Please review the disclaimer below.
