Active Ingredient
Oxymetazoline hydrochloride 0.05%
Original Nasal Pump Mist Spray
FDA Label NDC 67091-326
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Original Nasal Pump Mist (NDC 67091-326). 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 temperature
Inactive Ingredients
benzalkonium chloride, benzyl alcohol, edetate disodium, microcrystalline cellulose and carboxymethyl cellulose sodium, polyethylene glycol, povidone, purified water, sodium phosphate dibasic, sodium phosphate monobasic, xanthan gum.
Questions?
Call 800-824-1706
Monday-Friday 9am-4pm MST
Principal Display Panel
NDC 67091-326-30
*Compare to the active ingredient in AFRIN® No-Drip Original
WinCo® FOODS
ORIGINAL Nasal Spray
Pump Mist
Anti-Drip
OXYMETAZOLINE HCL
NASAL DECONGESTANT
Fast and Powerful Relief from Nasal Congestion
12 Hour Relief
1 FL OZ (30 mL)
*This product is not manufactured and distributed by Bayer, distributor of AFRIN® No Drip original.
TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS TORN OR MISSING
IMPORTANT: Keep this carton for future reference on full labeling |
DISTRIBUTED BY:
WINCO FOODS LLC,
BOISE, ID 83704
The Supermarket Low Price Leader
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Comments & Questions?
800-824-1706.www.wincofoods.com
Winco Foods Original Nasal Spray Pump Mist Anti-drip Oxymetazoline HCl Nasal Decongestant 1 Fl Oz (30 mL) (Image 01)
* Please review the disclaimer below.
