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| Product NDC Code | 70000-0676 | ||||
|---|---|---|---|---|---|
| Drug Name | Leader 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 | M012 | ||||
| Labeler Name | Cardinal Health 110,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 Adults and children 6 to under 12 years of age (with adult supervision):2 or 3 sprays in each nostril not more 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.To spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying, wipe nozzle clean after use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients benzalkonium chloride, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water
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 sinusitis upper respiratory allergies shrinks swollen membranes so you can breathe more freely
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.Leader Nasal Decongestant Oxymetazoline Hydrochloride OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE GLYCERIN POLYETHYLENE GLYCOL 300 PROPYLENE GLYCOL EDETATE DISODIUM SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE, DIBASIC, ANHYDROUS POVIDONE BENZALKONIUM CHLORIDE 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.Leader Original Nasal Spray NDC 70000-0676-1 Oxymetazoline Hydrochloride 0.05% 12 hour Nasal Mist Nasal Decongestant 1/2 FLOZ (15ML) Leader_Nasal_0.5_Carton Leader_Nasal_0.5_Labels
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 diease high blood pressure diabetes thyroid disease 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 the reach of children if swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store between 20° and 25°C (68° to 77°F) retain carton for future reference on full labeling
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 use more than directed do not use for more than three 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.
Pregnancy or breast feeding
Pregnancy or Breast feedingask a health professional before use.
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
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