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| Product NDC Code | 59779-787 | ||||
|---|---|---|---|---|---|
| Drug Name | Cvs health sinus relief |
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| Type | Brand | ||||
| Pharm Class | Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC] |
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| Active Ingredients |
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| Route | NASAL | ||||
| Dosage Form | SPRAY | ||||
| RxCUI drug identifier | 1000990 | ||||
| Application Number | part341 | ||||
| Labeler Name | CVS Pharmacy,Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Oxymetazoline hydrochloride 0.05%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions • adults and children 6 yrs, & older (with adult supervision): 2 or 3 sprays in each nostril without tilting your head, not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24 hours. • children 2 to under 6 yrs : ask a doctor • children under 2 yrs: Do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzalkonium chloride, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, polysorbate 80,propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses • for the temporary relief of sinus/ nasal congestion due to: • colds • hay fever • upper respiratory allergies
Purpose
Information about the drug product’s indications for use.Purpose Nasal Decongestant
Spl product data elements
Usually a list of ingredients in a drug product.CVS Health Sinus Relief oxymetazoline hydrochloride OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE BENZALKONIUM CHLORIDE BENZYL ALCOHOL CAMPHOR (NATURAL) EDETATE DISODIUM EUCALYPTOL MENTHOL POLYSORBATE 80 PROPYLENE GLYCOL SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS WATER
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel CVS Health ™ Compare to the active ingredient in Vicks ® Sinex ® * Nasal Spray Sinus Relief OXYMETAZOLINE HCl 0.05% Nasal decongestant 12 HOUR NASAL SPRAY FOR SINUS RELIEF 12 Hour 1/2 FL OZ (15 mL) DO NOT USE IF PRINTED SEAL OVER CAP IS TORN OR MISSNG IMPORTANT: Keep this carton for future reference on full labeling. *This product is not manufactured or distributed by Procter & Gamble, the distributor of Vicks ® Sinex ® Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895 © 2015 CVS/pharmacy CVS.com ® 1-800-SHOP CVS V-12431 CVS Quality Money Back Guarantee CVS Health Sinus Relief Oxymetazoline HCl 0.05% 15 mL
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to enlarged prostate gland
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away. ( 1-800-222-1222)
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor If Symptoms persist for more than 3 days
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product • do not exceed recommended dosage • use of this container by more than one person may spread infection. • temporary burning, stinging, sneezing or increase in nasal discharge may occur • frequent or prolonged use may cause nasal congestion to recur or worsen
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information • store at room temperature
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to enlarged prostate gland When using this product • do not exceed recommended dosage • use of this container by more than one person may spread infection. • temporary burning, stinging, sneezing or increase in nasal discharge may occur • frequent or prolonged use may cause nasal congestion to recur or worsen Stop use and ask a doctor If Symptoms persist for more than 3 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away. ( 1-800-222-1222)
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API