Quality Choice Nasal Spray Drug Facts

Manufacturer
QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
Effective date
2022-01-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:47:11

Label at a glance#

ProductQuality Choice Nasal Maximum Strength
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

▪ temporarily relieves nasal congestion due to: ▪ common cold ▪ hey fever ▪ upper respiratory allergies ▪ temporarily relieves sinus congestion and pressure ▪ shrinks swollen nasal membranes so you can breathe more freely

Dosage and administration

▪ 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 To Use: Shake well before use. Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Before using the first time, prime metered pump by depressing p...

Storage and handling

• store at room temperature TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS BROKEN OR MISSING How to use: Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Secure cap after use.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Oxymetazoline hydrochloride 0.05%

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves nasal congestion due to:
    • common cold
    • hey fever
    • upper respiratory allergies
  • temporarily relieves sinus congestion and pressure
  • shrinks swollen nasal membranes so you can breathe more freely

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

symptoms persist

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away at (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

To Use: Shake well before use. Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Before using the first time, prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle rim 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. Replace clip under rim and secure cap after use.

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS BROKEN OR MISSING

How to use:

Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Secure cap after use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, benzyl alcohol, camphor, edetate disodium, eucalyptol, glycerin, menthol, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic, xanthan gum.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUALITY CHOICE®

NDC# 63868-080-01

*Compare to Active Ingredient Afrin® No Drip Severe Congestion

12 hour relief

Nasal Mist No Drip

Severe Congestion

Oxymetazoline HCl 0.05%

Nasal Solution

Fast and Powerful Congestion Relief

For Colds & Allergies

No Drip Pump Mist Won’t Drip from Nose or Down Throat

Maximum Strength

Plus Menthol

Unique Formula with Menthol

1 FL OZ (30mL)

100% QC SATISFACTION GURANTEED

Distributed by C.D.M.A., Inc.©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 800-935-2362

*This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Afrin® No Drip Severe Congestion.

Quality Choice Nasal Mist No Drip Max Strength
Quality Choice Nasal Mist No Drip Max Strength

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN3
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD3
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OXYMETAZOLINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-080-012024-01-30C16284748780-11030e365-1575-111a-e063-dadaa90a10e2Quality Choice Nasal Spray Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-080-01Quality Choice NasalMaximum Strength30 mL in 1 BOTTLE, SPRAYSPRAY303
63868-080-01Quality Choice NasalMaximum Strength1 in 1 CARTONSPRAY13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-080QUALITY CHOICE NASAL MAXIMUM STRENGTH (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3Legacy NDC, 2 package rows20220119_b5aa76eb-acc8-495f-85c9-bfdbb2d80e2a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-08063868-080-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4647ee61-9bac-4ade-b1a5-93f97fc6c461b5aa76eb-acc8-495f-85c9-bfdbb2d80e2a2022-01-18WarningsExact identifier
spl id: 4647ee61-9bac-4ade-b1a5-93f97fc6c461
spl set id: b5aa76eb-acc8-495f-85c9-bfdbb2d80e2a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.