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Drug Facts
Cvs Severe Nasal Congestion Relief Spray
FDA Label NDC 69842-614
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Cvs Severe Nasal Congestion Relief (NDC 69842-614). 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, otc - stop use, 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:▪ a cold▪ hay fever or other upper respiratory allergies
▪ promotes nasal and sinus drainage▪ temporarily relieves sinus congestion and pressure▪ helps clear nasal passages; shrinks swollen membranes
Ask A Doctor Before Use If You Have
▪ heart disease▪ high blood pressure▪ thyroid disease▪ diabetes▪ difficulty in urination due to enlargement of the prostate gland
When Using This Product
▪ do not exceed recommended dosage▪ do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen▪ this product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge▪ the use of this container by more than one person may spread infection
Otc - Stop Use
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 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: consult a doctor.
Shake well before use.
To open: Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Before using for the first time, prime metered pump by depressing firmly several times. To spray, hold bottle with thumb at the base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress pump all the way down with a firm even stroke and sniff deeply. Wipe nozzle clean after use.
DO NOT DISCARD CAP.
Other Information
- store at room temperature
Inactive Ingredients
benzalkonium chloride, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, polysorbate 80, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic.
Questions?
1-866-467-2748
Principal Display Panel - 22 Ml Bottle Carton
*Compare to the active ingredient in Mucinex® SINUS-MAX® CLEAR & COOL Nasal Spray
NDC 69842-614-22
NASAL SPRAY
Oxymetazoline HCl 0.05%
Nasal Decongestant
SEVERE NASAL CONGESTION RELIEF
CLEAR & COOL
- Fast acting
- Lasts 12 Hours
- Cooling Menthol
flavor
3/4 FL OZ (22 mL)
IMPORTANT: Keep this carton for future reference for full labeling.
Distributed By:
Nasal Spray Severe Nasal Congestion Relief (Mucinex 01)
* Please review the disclaimer below.
