Vicks Sinex SEVERE MOISTURIZING ULTRA FINE MIST — v7

Vicks Sinex SEVERE MOISTURIZING ULTRA FINE MIST

5 Views

Version

v7

Effective date

October 1, 2025

Original packager

Yes

Sections captured

18

Identifiers

Document ID
401cdbca-e9d9-bea7-e063-6394a90a5066
Set ID
f4b01827-7444-3bfc-e053-2a95a90aebed
Application numbers
M012
Product NDCs
64336-015
Package NDCs
64336-015-01, 64336-015-02
Original packager NDCs

Names & Manufacturers

Brand names
Vicks Sinex SEVERE MOISTURIZING ULTRA FINE MIST
Generic names
OXYMETAZOLINE HYDROCHLORIDE
Manufacturer names
Procter & Gamble Manufacturing GmbH
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
OXYMETAZOLINE HYDROCHLORIDE
Routes
NASAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
UNII
K89MJ0S5VY
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient Oxymetazoline HCl 0.05%
Ask Doctor (1)

Sequence 1

Ask a doctor before use if you have heart disease thyroid disease diabetes high blood pressure trouble urinating due to enlarged prostate gland
Dosage And Administration (1)

Sequence 1

Directions Remove protective cap. Before using for the first time, prime the pump by firmly depressing its rim several times. Hold container with thumb at base and nozzle between first and second fingers. Without tilting your head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and inhale deeply. adults & children 6 yrs. & older (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 24 hours. children 2 to under 6 yrs. ask a doctor children under 2 yrs. do not use
Dosage And Administration Table (1)

Sequence 1

adults & children 6 yrs. & older (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 24 hours.
children 2 to under 6 yrs.ask a doctor
children under 2 yrs.do not use
Inactive Ingredient (1)

Sequence 1

Inactive ingredients acesulfame potassium, aloe, benzalkonium chloride, benzyl alcohol, citric acid anhydrous, edetate disodium, fragrance, polysorbate 80, purified water, sodium citrate, sorbitol.
Indications And Usage (1)

Sequence 1

Uses temporarily relieves nasal congestion due to a cold, hay fever, or other upper respiratory allergies sinus congestion and pressure
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children.
Overdosage (1)

Sequence 1

If swallowed, get medical help or contact a Poison Control Center right away
Package Label Principal Display Panel (1)

Sequence 1

PRINCIPAL DISPLAY PANEL - 15 ml Bottle Carton VICKS ® Sinex™ SEVERE Oxymetazoline HCl Nasal Decongestant MOISTURIZING ULTRA FINE MIST Fast Sinus Congestion & Pressure Relief Powerful Vicks Vapors Soothing Aloe 12 HOUR ½ FL OZ (15 mL) 015
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast-feeding, ask a health professional before use.
Purpose (1)

Sequence 1

Purpose Nasal decongestant
Questions (1)

Sequence 1

Questions? 1-800-873-8276
Spl Product Data Elements (1)

Sequence 1

Vicks Sinex SEVERE MOISTURIZING ULTRA FINE MIST Oxymetazoline Hydrochloride ACESULFAME POTASSIUM ALOE BENZALKONIUM CHLORIDE BENZYL ALCOHOL EDETATE DISODIUM POLYSORBATE 80 WATER SODIUM CITRATE SORBITOL ANHYDROUS CITRIC ACID OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE Clear
Spl Unclassified Section (3)

Sequence 1

Drug Facts

Sequence 2

Only selected information is listed on the bottle label. Keep this carton for future reference. TAMPER EVIDENT: Carton sealed for your protection.

Sequence 3

MADE IN GERMANY DIST. BY PROCTER & GAMBLE, CINCINNATI OH 45202
Stop Use (1)

Sequence 1

Stop use and ask a doctor if symptoms persist.
Storage And Handling (1)

Sequence 1

Other information do not exceed 25°C
Warnings (1)

Sequence 1

Warnings Ask a doctor before use if you have heart disease thyroid disease diabetes high blood pressure trouble urinating due to enlarged prostate gland
When Using (1)

Sequence 1

When using this product do not exceed recommended dosage do not use this product 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 increased nasal discharge may occur use of this container by more than one person may spread infection

OpenFDA raw payload

{'application_number': ['M012'],
 'brand_name': ['Vicks Sinex SEVERE MOISTURIZING ULTRA FINE MIST'],
 'generic_name': ['OXYMETAZOLINE HYDROCHLORIDE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Procter & Gamble Manufacturing GmbH'],
 'package_ndc': ['64336-015-01', '64336-015-02'],
 'product_ndc': ['64336-015'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['NASAL'],
 'spl_id': ['401cdbca-e9d9-bea7-e063-6394a90a5066'],
 'spl_set_id': ['f4b01827-7444-3bfc-e053-2a95a90aebed'],
 'substance_name': ['OXYMETAZOLINE HYDROCHLORIDE'],
 'unii': ['K89MJ0S5VY']}