quality choice nasal spray drug facts

Drug Facts

Composition & Product

Active Ingredients

oxymetazoline (.05 g)

Inactive Ingredients

benzalkonium chloride benzyl alcohol edetate disodium glycerin microcrystalline cellulose carboxymethylcellulose sodium, unspecified polyethylene glycol, unspecified povidone, unspecified water sodium phosphate, dibasic, unspecified form sodium phosphate, monobasic, unspecified form xanthan gum

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

otc monograph final active Since 2019-04-17

Medication Information

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

Nasal Decongestant

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

To Use: Shake well before use. Push down cup 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

•
store at room temperature

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

Inactive Ingredients

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

Description

Oxymetazoline hydrochloride 0.05%

Active Ingredient

Oxymetazoline hydrochloride 0.05%

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

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).

Ask A Doctor Before Use If You Have

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

Package/label Principal Display Panel

QUALITY CHOICE^®

NDC# 63868-079-01

*Compare to active ingredient in Afrin® No Drip Extra Moisturizing Pump Mist

12 Hour Relief

Nasal Mist No Drip

Extra Moisturizing

Oxymetazoline HCl 0.05%

Nasal Solution

Fast, powerful Congestion Relief

For Colds & Allergies

Helps Rehydrate

Dry Nasal Passages

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

1 FL OZ (30mL)

100% QC SATISFACTION GURANTEED

IMPORTANT: Keep this carton for future reference on full labeling.

How to use:

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

Distributed by C.D.M.A., Inc. ©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

*This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Afrin^® Extra Moisturizing.

Structured Label Content

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

Nasal Decongestant

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

To Use: Shake well before use. Push down cup 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 (Other information)

•
store at room temperature

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

Inactive Ingredients (Inactive ingredients)

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

Active Ingredient (Active ingredient)

Oxymetazoline hydrochloride 0.05%

When Using This 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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

symptoms persist

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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

Package/label Principal Display Panel (Package/Label Principal Display Panel)

QUALITY CHOICE^®

NDC# 63868-079-01

*Compare to active ingredient in Afrin® No Drip Extra Moisturizing Pump Mist

12 Hour Relief

Nasal Mist No Drip

Extra Moisturizing

Oxymetazoline HCl 0.05%

Nasal Solution

Fast, powerful Congestion Relief

For Colds & Allergies

Helps Rehydrate

Dry Nasal Passages

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

1 FL OZ (30mL)

100% QC SATISFACTION GURANTEED

IMPORTANT: Keep this carton for future reference on full labeling.

How to use:

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

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

*This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Afrin^® Extra Moisturizing.

Advanced Ingredient Data

[{"name": "OXYMETAZOLINE", "unii": "8VLN5B44ZY", "classCode": "ACTIB", "strengthNumerator": ".05", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM", "unii": "GR686LBA74", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM", "unii": "3980JIH2SW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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": "Nasal Decongestant", "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 To Use: Shake well before use . Push down cup 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.", "Active ingredient": "Oxymetazoline hydrochloride 0.05%", "Other information": "• store at room temperature TAMPER-EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS BROKEN OR MISSING", "Inactive ingredients": "benzalkonium chloride, benzyl alcohol, edetate disodium, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, purified water, sodium phosphate dibasic, sodium phosphate monobasic, xanthan gum.", "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", "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).", "Ask a doctor before use if you have": "▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ trouble urinating due to an enlarged prostate gland", "Package/Label Principal Display Panel": "QUALITY CHOICE ® NDC# 63868-079-01 *Compare to active ingredient in Afrin® No Drip Extra Moisturizing Pump Mist 12 Hour Relief Nasal Mist No Drip Extra Moisturizing Oxymetazoline HCl 0.05% Nasal Solution Fast, powerful Congestion Relief For Colds & Allergies Helps Rehydrate Dry Nasal Passages No Drip Pump Mist Won’t Drip from Nose or Down Throat 1 FL OZ (30mL) 100% QC SATISFACTION GURANTEED IMPORTANT: Keep this carton for future reference on full labeling. How to use: Push down cup while turning counter-clockwise and remove cap. Remove clip under rim. Secure cap after use. Distributed by C.D.M.A., Inc. © 43157 W. Nine Mile Novi, MI 48376-0995 www.qualitychoice.com Questions: 248-449-9300 *This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Afrin ® Extra Moisturizing."}

quality choice nasal spray drug facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information