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Nasal - Medication Information

Product NDC Code 37835-995
Drug Name

Nasal

Type Brand
Pharm Class Imidazolines [CS],
Increased Sympathetic Activity [PE],
Vasoconstriction [PE],
Vasoconstrictor [EPC]
Active Ingredients
Oxymetazoline hydrochloride .05 g/100ml
Route NASAL
Dosage Form SPRAY
RxCUI drug identifier 1000990
Application Number M012
Labeler Name Bi-Mart
Packages
Package NDC Code Description
37835-995-34 1 bottle, spray in 1 carton (37835-995-34) / 30 ml in 1 bottle, spray
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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 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 in any 24-hour period. children under 6 years of age: ask a doctor. 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, dibasic sodium phosphate, edetate disodium dihydrate, monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified 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 upper respiratory allergies temporarily relieves sinus congestion and pressure shrinks swollen nasal 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.
NASAL Oxymetazoline Hydrochloride BENZALKONIUM CHLORIDE SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM EDETATE DISODIUM SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE

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 BI-MART *Compare to the active ingredient in Afrin ® LONG LASTING NASAL SPRAY Oxymetazoline hydrochloride 0.05% NASAL DECONGESTANT FAST CONGESTION RELIEF FOR UP TO 12 HOURS RELIEVES NASAL CONGESTION DUE TO COLDS AND ALLERGIES 1 FL. OZ. (30 mL) 11523-1167

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.
Drug Facts Distributed by: BI-MART Eugene, OR 97402 *This product is not manufactured or distributed by the owner of the registered trademark Afrin ®

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 an 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. If swallowed, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? call toll-free 1-800-935-6737

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 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

Pregnancy or breast feeding

Pregnancy or Breast feeding
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 do not use if seal around cap is missing or damaged save carton for complete information store between 20° to 25°C (68°F and 77°F)

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 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 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