Afrin Nodrip Allergy Sinus Night Ui1612461

Afrin Nodrip Allergy Sinus Night Ui1612461
SPL v7
SPL
SPL Set ID b023a571-7e54-7c63-e053-2a95a90a0f78
Route
NASAL
Published
Effective Date 2023-02-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.5 mg)
Inactive Ingredients
Carboxymethylcellulose Sodium Sodium Phosphate, Monobasic Water Edetate Disodium Glycerin Benzalkonium Chloride Povidone Polyethylene Glycol, Unspecified Benzyl Alcohol Microcrystalline Cellulose Hibiscus Bifurcatus Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-09

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

▪ temporarily relieves nasal congestion due to:

▪ common cold ▪hay fever

▪ upper respiratory allergies

▪ reduces swelling of nasal passages so you can breathe more freely

▪ temporarily relieves sinus congestion and pressure

Dosage and Administration

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. Hold white tabs, press 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

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if symptoms persist

Section 50567-7

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

Section 50569-3

▪ Ask a doctor before use if you have

▪ heart disease • high blood pressure

▪ thyroid disease ▪ diabetes

▪ trouble urinating due to an enlarged prostate gland

Section 51727-6

Inactive ingredients benzalkonium chloride solution, benzyl alcohol, dibasic sodium phosphate, edetate disodium, flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, purified water

Section 53413-1

Questions or comments? 1-800-317-2165

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55106-9

Active ingredient Purpose

Oxymetazoline hydrochloride 0.05%…….…....Nasal decongestant

Section 60561-8

Other information

▪ store between 20º to 25ºC (68º to 77ºF)

▪ retain carton for future reference on full labeling

Carton Label 15 Ml

Oxymetazoline HCl

Nasal Solution-Nasal Decongestant

AFRIN

NODRIP

Wont drive from nose or down throat

Allergy Sinus

Night

with soothing chamomile scent

PUMP MIST

Instant Congestion

Relief from Allergies

for a More Restful Night

Reduces

Swelling of

Nasal

Passages

1/2 FL OZ (15mL)


Structured Label Content

Indications and Usage (34067-9)

Uses

▪ temporarily relieves nasal congestion due to:

▪ common cold ▪hay fever

▪ upper respiratory allergies

▪ reduces swelling of nasal passages so you can breathe more freely

▪ temporarily relieves sinus congestion and pressure

Dosage and Administration (34068-7)

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. Hold white tabs, press 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.

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms persist

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

▪ Ask a doctor before use if you have

▪ heart disease • high blood pressure

▪ thyroid disease ▪ diabetes

▪ trouble urinating due to an enlarged prostate gland

Section 51727-6 (51727-6)

Inactive ingredients benzalkonium chloride solution, benzyl alcohol, dibasic sodium phosphate, edetate disodium, flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, purified water

Section 53413-1 (53413-1)

Questions or comments? 1-800-317-2165

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55106-9 (55106-9)

Active ingredient Purpose

Oxymetazoline hydrochloride 0.05%…….…....Nasal decongestant

Section 60561-8 (60561-8)

Other information

▪ store between 20º to 25ºC (68º to 77ºF)

▪ retain carton for future reference on full labeling

Carton Label 15 Ml (Carton label 15 mL)

Oxymetazoline HCl

Nasal Solution-Nasal Decongestant

AFRIN

NODRIP

Wont drive from nose or down throat

Allergy Sinus

Night

with soothing chamomile scent

PUMP MIST

Instant Congestion

Relief from Allergies

for a More Restful Night

Reduces

Swelling of

Nasal

Passages

1/2 FL OZ (15mL)


Advanced Ingredient Data


Raw Label Data

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