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Product NDC Code | 83522-001 | ||||
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Drug Name | Medix nasal decongestant oxymetazoline hydrochloride |
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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 | TOPICAL | ||||
Dosage Form | LIQUID | ||||
RxCUI drug identifier | 1000990 | ||||
Application Number | M012 | ||||
Labeler Name | Medic -33, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Oxymetazoline hydrochloride 0.05% Purpose 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 to 12 hours. Do not exceed 2 doses in any 24-hour period. Children under 6 years of age: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Glutathione, menthol oil, pyrroloquinoline quinine, sodium nitrate, wintergreen oil, 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 for the temporary relief of nasal congestion 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.Medix Nasal Decongestant Oxymetazoline Hydrochloride OXYMETAZOLINE HYDROCHLORIDE GLUTATHIONE PYRROLOQUINOLINEDIONE TRICARBOXYLIC ACID SODIUM NITRATE METHYL SALICYLATE 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.Package Labeling: Label
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
Other information Do not use if the tamper-proof seal is damaged or broken.
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 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.Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.
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 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 or Comments? 305-861-1457
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. this product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge. the use of this container by more than one person may spread infection.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, ask 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 Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor. 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 gland When using this product do not exceed recommended dosage. this product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge. the use of this container by more than one person may spread infection. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact 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