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Product NDC Code | 0363-2021 | ||||
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Drug Name | Severe anefrin |
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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 | NASAL | ||||
Dosage Form | LIQUID | ||||
Application Number | part341 | ||||
Labeler Name | WALGREENS | ||||
Packages |
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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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Benzalkonium Chloride Solution, Camphor, CArboxymethyl Cellulose Sodium, Cellulose Gum, Disodium EDTA, Disodium Phosphate, Eucalyptol, Glycerin, Menthol, Microcrystalline Cellulose, PEG-6, Povidone, Propylene Glycol, Purified Water, Sodium Phosphate Monobasic
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.To Use: Shake well before use. Hold white tabs, press grooved area of cap firmly and turn counterclockwise. Before using the firsst time, prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumn at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Secure cap after use.
Uses • temporarily relives nasal congestions due to: • common cold • hay fever • upper respiratory allergies • temporarily relieves sinus congestgions and pressure • shrinks swollen nasal membranes so you can breath 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.Severe Anefrin OXYMETAZOLINE HYDROCHLORIDE EDETATE DISODIUM EDETATE DISODIUM ANHYDROUS EUCALYPTOL GLYCERIN MENTHOL, (+)- PEG-6 STEARATE CAMPHOR, (-)- POVIDONE K30 PROPYLENE GLYCOL SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED BENZALKONIUM CHLORIDE 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.Severe Anefrin Nasal Spray NO DRIP MAXIMUM STRENGTH 12 HOUR + MENTHOL severe anefrin
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.DISTRIBUTED BY: WALGREENS CO. 200 WILMOT RD., DEERFIELD, IL 60015 100% SATISFACTION GUARANTEED walgreens.com ©2020 Walgreen Co.
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 or comments? 1-800-925-4733.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf Pregnant or breast-feeding, 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 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 nasla congestion to recur or worsen. • temporary discomfort such as burning, stinging, sneezing or an increase in nasla discharge may occur • use of this container by more than one person may spread infection. Stop use and ask a doctor if symptoms persist
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