FDA Label for Quality Choice Nasal Original
View Indications, Usage & Precautions
Quality Choice Nasal Original Product Label
The following document was submitted to the FDA by the labeler of this product Quality Choice (chain Drug Marketing Association). 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.
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
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 (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. Before using the first time, remove the protective cap from the tip by pressing and twisting off the cap. Rotate the lock tab to align arrow marks to unlock the pump. Prime metered 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. Lock the pump by ensuring that arrow marks are not aligned and replace the proactive cap on tip.
Other Information
• store at 20-25°C (68-77°F)• retain carton for future reference on full labeling
SAFETY SEALED: Do not use if printed seal over cap is broken or missing
Inactive Ingredients
benzalkonium chloride solution, benzyl alcohol, edetate disodium, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, purified water, sodium phosphate dibasic, sodium phosphate monobasic, xanthan gum.
Package/Label Principal Display Panel
QUALITY CHOICE®
NDC# 63868-077-01
*Compare to Active Ingredient Afrin® No Drip Original
12 hour relief
Nasal Mist No Drip
Nasal Decongestant
Oxymetazoline HCl 0.05%
Fast and Powerful Congestion Relief
No Drip Pump Mist Won’t Drip from Nose or Drip from Nose or Down Throat
Original
1 FL OZ (30mL)
100% QC SATISFACTION GURANTEED
Distributed by C.D.M.A., Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995
Questions: 248-449-9300
*This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Afrin® No Drip Original.
* Please review the disclaimer below.