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|Product NDC Code||63187-701|
|Pharm Class||Imidazolines [CS],
Increased Sympathetic Activity [PE],
|Labeler Name||Proficient Rx LP|
|Check if available Online||Shop Optum Store - Rx always ships FREE|
Active ingredientA list of the active, medicinal ingredients in the drug product.
Active ingredient Oxymetazoline hydrochloride 0.05%
Dosage and administrationInformation 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 to 12 hours • do not exceed 2 doses within any 24-hour period • children under 6 years of age: consult a doctor To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use
Inactive ingredientA list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate, edetate disodium, hydrochloric acid, monobasic sodium phosphate, polyethylene glycol 1450, povidone, propylene glycol, purified water
Indications and usageA 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 nasal congestion due to the common cold, hay fever or other upper respiratory allergies • shrinks swollen membranes so you can breathe more freely
PurposeInformation about the drug product’s indications for use.
Purpose Nasal decongestant
Spl product data elementsUsually a list of ingredients in a drug product.
Nasal Oxymetazoline Hydrochloride Oxymetazoline Hydrochloride Oxymetazoline Water Benzalkonium Chloride Edetate Disodium Propylene Glycol Benzyl Alcohol SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM POVIDONE, UNSPECIFIED Hydrochloric Acid Polyethylene Glycol 1450
Package label principal display panelThe 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 - 15 mL Carton NDC 63187-701-15 Relabeled by: Proficient Rx LP, Thousand Oaks, CA 91320 Soothing - 12 Hour NASAL DECONGESTANT Spray REGULAR oxymetazoline hydrochloride 0.05% RELIEVES CONGESTION FAST Compare to active ingredient of Afrin® 1/2 FL.OZ. (15 mL) 63187-701-15
Spl unclassified sectionInformation 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.
Drug Facts Other information
Ask doctorInformation 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 childrenInformation 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.
QuestionsA telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? To Report Adverse Drug Event Call: (800) 616-2471
Stop useInformation 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 doctor if symptoms persist.
When usingInformation 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 1. do not exceed recommended dosage 2. do not use for more than 3 days. Use only as directed. 3. may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge 4. the use of this container by more than one person may spread infection 5. frequent or prolonged use may cause nasal congestion to recur or worsen
Pregnancy or breast feedingPregnancy or Breast feeding
If pregnant or breast-feeding, ask a health professional before use.
Storage and handlingInformation about safe storage and handling of the drug product.
• store between 20° to 25° C (68° to 77° F)
WarningsInformation 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 1. do not exceed recommended dosage 2. do not use for more than 3 days. Use only as directed. 3. may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge 4. the use of this container by more than one person may spread infection 5. frequent or prolonged use may cause nasal congestion to recur or worsen Stop use and ask 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