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Drug Facts
Only selected information is listed on the bottle label. Keep this carton for future reference.
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MADE IN GERMANY
DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202
Vicks Sinex Severe Spray
FDA Label NDC 64336-015
15 label sections · Submitted to the FDA by Procter & Gamble Manufacturing Gmbh · 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 (NDC 64336-015). 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, uses, otc - ask doctor, 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
Uses
temporarily relieves
- nasal congestion due to a cold, hay fever, or other upper respiratory allergies
- sinus congestion and pressure
Otc - Ask Doctor
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 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.
Overdosage
If swallowed, get medical help or contact a Poison Control Center right away
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 |
Other Information
- do not exceed 25°C
Inactive Ingredients
acesulfame potassium, aloe, benzalkonium chloride, benzyl alcohol, citric acid anhydrous, edetate disodium, fragrance, polysorbate 80, purified water, sodium citrate, sorbitol.
Questions?
1-800-873-8276
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 (015)
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