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Children afrin extra moisturizing stuffy nose pump mist stuffy nose pump mist - Medication Information

Product NDC Code 11523-0091
Drug Name

Children afrin extra moisturizing stuffy nose pump mist stuffy nose pump mist

Type Brand
Pharm Class Imidazolines [CS],
Increased Sympathetic Activity [PE],
Vasoconstriction [PE],
Vasoconstrictor [EPC]
Active Ingredients
Oxymetazoline hydrochloride .025 g/100ml
Route NASAL
Dosage Form SPRAY, METERED
RxCUI drug identifier 2606550,
2606551
Application Number M012
Labeler Name Bayer HealthCare LLC.
Packages
Package NDC Code Description
11523-0091-1 1 bottle, pump in 1 carton (11523-0091-1) / 15 ml in 1 bottle, pump
11523-0091-2 2 bottle, pump in 1 carton (11523-0091-2) / 15 ml in 1 bottle, pump
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Oxymetazoline hydrochloride 0.025%

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 children 2 to under 6 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Use only recommended amount. Do not exceed 2 doses in any 24-hour period. children under 2 years of age: consult a doctor To Use: Shake well before use. Hold white tabs, press grooved area of cap firmly and turn counter clockwise. Before using the first time, prime metered pump by depressing pump firmly up to 10 times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke. Wipe nozzle clean after use. Secure cap after use.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients benzalkonium chloride, dibasic sodium phosphate, edetate disodium, glycerin, 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.
Children Afrin Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump Mist Oxymetazoline hydrochloride GLYCERIN BENZALKONIUM CHLORIDE EDETATE DISODIUM POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE WATER SODIUM PHOSPHATE, DIBASIC SODIUM PHOSPHATE, MONOBASIC OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE PROPYLENE GLYCOL

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 - 15 mL Bottle Carton Oxymetazoline HCl Nasal Solution-Nasal Decongestant Children's Afrin ® No Drip EXtra Moisturizing Stuffy Nose Pump Mist Carton kids 6 under artwork

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

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? Call 1-800-317-2165

Storage and handling

Information about safe storage and handling of the drug product.
Other information store between 20° to 25°C (68° to 77°F) retain carton for future reference on full labeling

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 or a child has heart disease high blood pressure thyroid disease diabetes 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 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