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Careone fast acting nasal - Medication Information

Product NDC Code 41520-729
Drug Name

Careone fast acting nasal

Type Brand
Pharm Class Adrenergic alpha1-Agonists [MoA],
alpha-1 Adrenergic Agonist [EPC]
Active Ingredients
Phenylephrine hydrochloride 1 g/100ml
Route NASAL
Dosage Form SPRAY
RxCUI drug identifier 1087043
Application Number part341
Labeler Name American Sales Company
Packages
Package NDC Code Description
41520-729-10 1 bottle in 1 carton (41520-729-10) / 30 ml in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Phenylephrine hydrochloride 1%

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 12 years and over: 2 or 3 sprays in each nostril not more often than every 4 hours • children under 12 years: ask a doctor • Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients benzalkonium chloride, benzyl alcohol, boric acid, purified water, sodium borate

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

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.
CareOne Fast Acting Nasal Phenylephrine hydrochloride PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE BENZALKONIUM CHLORIDE BENZYL ALCOHOL BORIC ACID SODIUM BORATE WATER

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 Compare to the active ingredient in 4-Way® Fast Acting Nasal Spray FAST ACTING NASAL SPRAY Phenylephrine Hydrochloride 1 % Nasal Decongestant 4hr Relieves: Nasal Congestion Swollen Nasal Membranes Sinus Congestion Sinus Pressure Gluten Free OUR PHARMACISTS RECOMMEND 1 FL OZ (30mL) 648D4OF-fast-acting-nasal-spray.jpg

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 • diabetes • thyroid disease • high blood pressure • 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. (1-800-222-1222)

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? 1-800-719-9260

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. Frequent or prolonged use may cause nasal congestion to come back or get worse. • use only as directed • 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 • store at 20°-25°C (68°-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 • diabetes • thyroid disease • high blood pressure • 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. Frequent or prolonged use may cause nasal congestion to come back or get worse. • use only as directed • 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