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| Product NDC Code | 67510-0068 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Nasal decongestant |
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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 | Kareway Product, 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 HCl 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 Shake well before use. To spray, remove the clear plastic cap. Hold bottle with thumb at base and nozzle between first and second fingers. If this is the first time you are using the pump, spray several times into the air until you get a fine mist. If you have not used the pump for 14 days, spray several times into the air before using again. Insert nozzle into nostril. Spray upward while breathing in through the nose. Repeat in other nostril. Wipe nozzle clean after use. Put clear plastic cap back on the bottle Do not exceed 2 doses in any 24 hour period. adults and children 6 to under 12 years of age (with adult supervision) 2 or 3 spray in each nostril not more often than every 10 to 12 hours children under 6 years of age ask a doctor
| adults and children 6 to under 12 years of age (with adult supervision) | 2 or 3 spray in each nostril not more often than every 10 to 12 hours |
| children under 6 years of age | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzalkonium chloride, edetate disodium, propylene glycol, purified water, sodium dihydrogen phosphate
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 temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies sinusitis reduces swelling of nasal passages; shrinks swollen membranes temporarily restores freer breathing through the nose
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.Nasal Decongestant Oxymetazoline HCl PROPYLENE GLYCOL EDETATE DISODIUM WATER OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE SODIUM PHOSPHATE, MONOBASIC BENZALKONIUM CHLORIDE
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.Carton image Nasal Spray Original carton
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 difficulty in urination due to enlargement of the prostate
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. If swallowed, get medical help or contact a Poison Control Center right away.
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
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 only as directed. frequent of prolonged use may cause nasal congestion to recur or worsen temporary discomfort such as burning, stinging, or an increase in nasal discharge may occur use of this container by more than one person may spread infection
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(59°~86°F) retain carton for future reference on full labeling
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 Do not use this product for more than 3 days 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 When using this product do not exceed recommended dosage use only as directed. frequent of prolonged use may cause nasal congestion to recur or worsen temporary discomfort such as burning, stinging, 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.
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