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| Product NDC Code | 63868-607 | ||||
|---|---|---|---|---|---|
| Drug Name | Oxymetazoline hydrochloride |
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| Type | Generic | ||||
| 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 | CHAIN DRUG MARKETING ASSOCIATION 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 Purpose Oxymetazoline HCl 0.05%............. Nasal decongestant
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 often than every 10-12 hours. Do not exceed 2 doses in any 24-hour period. children under 6 years of age: ask a doctor Shake well before use. to spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzalkonium chloride solution, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate monobasic, sodium phosphate dibasic
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 shrinks swollen nasal membranes so you can breathe more freely
Purpose
Information about the drug product’s indications for use.Nasal Decongestant
Spl product data elements
Usually a list of ingredients in a drug product.OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE BENZALKONIUM CHLORIDE EDETATE DISODIUM POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE, DIBASIC
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 NDC-63868- 607 -01 containerlabel607
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Tamper Evident: Do not use the product if the temper evident seal is broken or missing. This product is not manufactured or distributed by Bayer HealthCare LLC distributor of Afrin Original Nasal Spray. Questions or comments? 1-800-935-2362, (Mon-Fri. 9 am-5 pm EST) Distributed by C.D.M.A Inc. 43157 W 9 Mile Rd Novi, MI 48375 www.qualitychoice.com Question: 800-935-2362
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 thyroid disease high blood pressure diabetes trouble urinating due to an enlarged prostate gland
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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
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 chlldren. 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. If 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 between 20˚C to 25˚C (68˚F to 77˚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 Ask a doctor before use if you have heart disease thyroid disease high blood pressure 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
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