Package/label Principal Display Panel

Package/label Principal Display Panel
SPL v6
SPL
SPL Set ID 7846dfc5-11e3-4fde-b6e0-ed0bf46f2964
Route
NASAL
Published
Effective Date 2024-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Oxymetazoline hydrochloride 0.05%


Medication Information

Indications and Usage

• 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

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. Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Before using the first time, prime metered pump by depressing pump firmly several 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 and sniff deeply. Wipe nozzle clean after use. Secure cap after use.

Description

Oxymetazoline hydrochloride 0.05%

Section 44425-7

• store at 20-25°C (68-77°F) • retain carton for future reference on full labeling

Section 50565-1

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

Section 50566-9

symptoms persist

Section 50567-7

• 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

Section 50569-3

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

Section 51727-6

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

Section 51945-4

COMPARE TO the active ingredient of AFRIN® NO DRIP See side panel OUR PHARMACIST RECOMMENDED Maximum Strength plus Menthol No Drip Nasal Spray Oxymetazoline HCl 0.05% Nasal Decongestant SEVERE CONGESTION PUMP MIST #1 Doctor Recommended Adult Nasal Spray Active Ingredient Won’t Drip From Nose or Down Throat Fast, Powerful Congestion Relief For Colds & Allergies 12 HOUR RELIEF 1 FL OZ (30 mL)

Section 53413-1

1-800-632-6900

Section 53414-9

ask a health professional before use.

Section 55105-1

Nasal decongestant

Section 55106-9

Oxymetazoline hydrochloride 0.05%


Structured Label Content

Indications and Usage (34067-9)

• 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

Dosage and Administration (34068-7)

• 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. Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Before using the first time, prime metered pump by depressing pump firmly several 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 and sniff deeply. Wipe nozzle clean after use. Secure cap after use.

Section 44425-7 (44425-7)

• store at 20-25°C (68-77°F) • retain carton for future reference on full labeling

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

symptoms persist

Section 50567-7 (50567-7)

• 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

Section 50569-3 (50569-3)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

COMPARE TO the active ingredient of AFRIN® NO DRIP See side panel OUR PHARMACIST RECOMMENDED Maximum Strength plus Menthol No Drip Nasal Spray Oxymetazoline HCl 0.05% Nasal Decongestant SEVERE CONGESTION PUMP MIST #1 Doctor Recommended Adult Nasal Spray Active Ingredient Won’t Drip From Nose or Down Throat Fast, Powerful Congestion Relief For Colds & Allergies 12 HOUR RELIEF 1 FL OZ (30 mL)

Section 53413-1 (53413-1)

1-800-632-6900

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Nasal decongestant

Section 55106-9 (55106-9)

Oxymetazoline hydrochloride 0.05%


Raw Label Data

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