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Quality choice - Medication Information

Product NDC Code 63868-699
Drug Name

Quality choice

Type Brand
Pharm Class Imidazolines [CS],
Increased Sympathetic Activity [PE],
Vasoconstriction [PE],
Vasoconstrictor [EPC]
Active Ingredients
Oxymetazoline hydrochloride .05 g/100ml
Route NASAL
Dosage Form SPRAY
RxCUI drug identifier 1000990
Application Number M012
Labeler Name CHAIN DRUG MARKETING ASSOCIATION
Packages
Package NDC Code Description
63868-699-22 1 bottle, pump in 1 carton (63868-699-22) / 22 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 0.05%

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 Shake well before use: Before using the first time, remove the protective cap from the tip by pressing and twisting off the cap. Rotate the lock tab to align arrow marks to unlock the pump. Prime the lock tab to align arrow marks to unlock the pump. Prime metered pump by depressing pump firmly several times. To spray, hold bottle with thump 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. Lock the pump by ensuring that arrow marks are not aligned and replace the protective cap on tip.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients benzalkonium chloride, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, polysorbate 80, propylene glycol, purified water, sodium phosphate dibasic, 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.
Uses temporarily relieves nasal congestion due to: • a cold • hay fever • upper respiratory allergies • promotes nasal and sinus drainage • temporarily relieves sinus congestion and pressure • helps clear nasal passages; shrinks swollen nasal membranes

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.
Quality Choice Oxymetazoline Hydrochloride OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE BENZALKONIUM CHLORIDE BENZYL ALCOHOL CAMPHOR (NATURAL) EDETATE DISODIUM EUCALYPTOL MENTHOL, UNSPECIFIED FORM POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM

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 NDC# 63868-699-22 QUALITY CHOICE ® * Compare to Active Ingredient in Mucinex® Full Force Nasal Spray 12 Hour Relief Nasal Spray Nasal Decongestant Oxymetazoline HCl 0.05% Fast Relief of Sinus Pressure & Nasal Congestion 3/4 FL OZ (22 mL) 100% QC SATISFACTION GUARANTEED Distributed by C.D.M.A. Inc. © 43157 W 9 Mile Rd Novi, MI 48375 www.qualitychoice.com Questions: 248-449-9300 *This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex ® Full Force™ Nasal Spray. Quality Choice 12 Hours Relief Nasal Spray Oxymetazoline HCl

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 • 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? 1-866-467-2748

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. 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

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 room temperature • 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

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