The following Structured Product Label (SPL) was submitted to the FDA by Procter & Gamble Manufacturing Gmbh for the product Vicks Sinex Severe Congestion (NDC 64336-002). 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.
Drug Facts
Note: This container is properly filled when approximately half full. Air space equal to one half of volume is necessary to propel the fine spray.
Only selected information is listed on the bottle label. Keep this container for future reference.
TAMPER EVIDENT: CARTON SEALED FOR YOUR PROTECTION.
MADE IN GERMANY
DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202
Oxymetazoline HCl 0.05%
Nasal decongestant
temporarily relieves
Ask a doctor before use if you have
ask a health professional before use.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away
| adults & children 6 years & 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 years | ask a doctor |
| children under 2 years | do not use |
benzalkonium chloride, benzyl alcohol, citric acid anhydrous, edetate disodium, fragrance, polysorbate 80, propylene glycol, purified water, sodium citrate
1-800-873-8276
VICKS ®
Sinex™
SEVERE CONGESTION
Oxymetazoline HCl Nasal Decongestant
NASAL SPRAY
12 HOUR RELIEF
0.5 FL OZ
(15 ml)
002 (002)
* Please review the disclaimer below.
