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Product NDC Code | 0363-2023 | ||||
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Drug Name | Ephrine nose drops |
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Type | Brand | ||||
Pharm Class | Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
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Active Ingredients |
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Route | NASAL | ||||
Dosage Form | SOLUTION/ DROPS | ||||
RxCUI drug identifier | 1234563 | ||||
Application Number | M012 | ||||
Labeler Name | Walgreens | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Phenylephrine hydrochloride 1.0%
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 •use only as directed •adults and children 12 years of age and older: 2 or 3 drops in each nostril not more often than every 4 hours •children under 12 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients anhydrous citric acid, benzalkonium chloride solution, purified water, sodium chloride, sodium citrate
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 membranes so you can breathe more freely •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.Ephrine Nose Drops Phenylephrine hydrochloride SODIUM CITRATE WATER SODIUM CHLORIDE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE BENZALKONIUM CHLORIDE ANHYDROUS CITRIC ACID
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 (carton) Compare to Neo-Synephrine® active ingredient Ephrine Nose Drops PHENYLEPHRINE HCl 1.0% / NASAL DECONGESTANT EXTRA STRENGTH Fast relief 1 FL OZ (30 mL)
Principal Display Panel (Label) Package Label
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 (1-800-222-1222).
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information •store at 20-25°C (68-77°F) •Protect from light. Store in outer carton until contents used.
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 ? 1-800-925-4733
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 if you have ever had an allergic reaction to this product or any of its ingredients 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 (1-800-222-1222).
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