Active Ingredient
Oxymetazoline hydrochloride 0.05%
No Drip Nasal Mist Nasal Decongestant Severe Congestion Spray
FDA Label NDC 49035-991
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores,inc., for the product No Drip Nasal Mist Nasal Decongestant Severe Congestion (NDC 49035-991). 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 active ingredient, purpose, uses, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away at 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
Shake well before use. Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Before using the first time, prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle rim 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. Replace clip under rim and secure cap after use.
Other Information
- store at room temperature
Inactive Ingredients
benzalkonium chloride, benzyl alcohol, camphor ,edetate disodium, eucalyptol, glycerin, menthol, microcrystalline cellulose and carboxymethyl cellulose sodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic, xanthan gum.
Questions Or Comments?
1-866-467-2748
Principal Display Panel
NDC 49035-991-30
Compare to the active ingredient in Afrin® No-Drip Severe Congestion Pump Mist*
NO DRIP
NASAL MIST
Nasal Decongestant
Oxymetazoline HCl 0.05%
SEVERE CONGESTION
12 Hour Pump Mist
Fast, Powerful Congestion Relief
For Colds & Allergies
Maximum Strength
Unique Formula with Menthol
1 FL OZ (30 mL)
*This product is not manufactured and distributed by Bayer Healthcare LLC, distributor of Afrin® No Drip Severe Congestion Pump Mist.
IMPORTANT: Keep this carton for future reference on full labeling. |
TAMPER EVIDENT: DO NOT USE IF SEAL OVER CAP IS BROKEN OR MISSING |
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No Drip Nasal Mist Nasal Decongestant Severe Congestion 1 Fl Oz (Image 01)
* Please review the disclaimer below.
