FDA Label for Quality Choice No Drip Nasal Mist
View Indications, Usage & Precautions
Quality Choice No Drip Nasal Mist 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 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
To Use: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 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
TAMPER-EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS TORN OR MISSING
How to use:
Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Secure cap after use.
Inactive Ingredients
benzalkonium chloride, 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 83324-142-01
*Compare to the Active Ingredient in Afrin® No Drip Original Pump Mist
No Drip
Up to 12 Hour Relief
Nasal Mist
Original Decongestant
Oxymetazoline HCl 0.05%
Nasal Solution
Fast, Powerful Congestion Relief
For Colds & Allergies
Won’t Drip from Nose or Down Throat
Maximum Strength
1 FL OZ (30mL)
IMPORTANT:Keep the carton for future reference for full labeling. |
100% QC SATISFACTION GURANTEED
Distributed by C.D.M.A., Inc.
Novi, MI 48375
Questions: 800-935-2362
*This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Afrin ®No Drip Original Pump Mist.
* Please review the disclaimer below.
