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Drug Facts
MADE IN GERMANY
DIST. BY: PROCTER & GAMBLE,
CINCINNATI, OH 45202
Vicks Sinex Severe Congestion Spray
FDA Label NDC 64336-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Procter & Gamble Manufacturing Gmbh for the product Vicks Sinex Severe Congestion (NDC 64336-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient, purpose, usestemporariliy relieves, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Oxymetazoline HCl 0.05%
Purpose
Nasal decongestant
Usestemporariliy Relieves
- nasal congestion due to a cold, hay fever, or other upper respiratory allergies
- sinus congestion and pressure
Ask A Doctor Before Use If You Have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to enlarged prostate gland
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
Stop Use And Ask A Doctor If
- symptoms persist.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
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, inset 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 |
Other Information
- store at no greater than 25°C
Inactive Ingredients
benzalkonium chloride, benzyl alcohol, citric acid anhydrous, edetate disodium, fragrance, polysorbate 80, propylene glycol, purified water, sodium citrate
Questions?
1-800-873-8276
Only Selected Information Is Listed On The Bottle Label. Keep This Carton For Future Reference.
TAMPER EVIDENT:CARTON SEALED FOR YOUR PROTECTION.
Principal Display Panel - 15 Ml Bottle Carton
VICKS ®
Sinex™ SEVERE CONGESTION
Oxymetazoline HCl: Nasal Decongestant
VapoCOOL ULTRA FINE MIST
- Fast Relief for Sinus & Nasal Congestion
- Sinus Pressure
- Powerful rush of VICKS Vapors
12 HOUR RELIEF
0.5 FL OZ (15 mL)
005 (005)
* Please review the disclaimer below.
