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NDC 37000-0433-01 Vicks Sinex 0.0005095 g/mL Details
Vicks Sinex 0.0005095 g/mL
Vicks Sinex is a NASAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by The Procter & Gamble Manufacturing Company. The primary component is OXYMETAZOLINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Oxymetazoline nasal spray is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Oxymetazoline nasal spray should not be used to treat children younger than 6 years of age unless it is recommended by a doctor. Children 6 to 12 years of age should use oxymetazoline nasal spray carefully and under adult supervision. Oxymetazoline is in a class of medications called nasal decongestants. It works by narrowing the blood vessels in the nasal passages.
Related Packages: 37000-0433-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Oxymetazoline Nasal Spray
Product Information
| NDC | 37000-0433 |
|---|---|
| Product ID | 37000-433_eb5097c7-c41a-2eb9-e053-2995a90a055e |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Vicks Sinex |
| Proprietary Name Suffix | 12 Hour Decongestant Ultra Fine Mist |
| Non-Proprietary Name | Oxymetazoline Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SPRAY |
| Route | NASAL |
| Active Ingredient Strength | 0.0005095 |
| Active Ingredient Units | g/mL |
| Substance Name | OXYMETAZOLINE HYDROCHLORIDE |
| Labeler Name | The Procter & Gamble Manufacturing Company |
| Pharmaceutical Class | Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 37000-0433-01 (37000043301)
| NDC Package Code | 37000-433-01 |
|---|---|
| Billing NDC | 37000043301 |
| Package | 1 BOTTLE, PUMP in 1 CARTON (37000-433-01) / 15 mL in 1 BOTTLE, PUMP |
| Marketing Start Date | 2015-04-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL a3503f25-c158-478b-87c6-b218961aa5f2 Details
Uses
Warnings
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
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 |
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
INGREDIENTS AND APPEARANCE
| VICKS SINEX
12 HOUR DECONGESTANT ULTRA FINE MIST
oxymetazoline hydrochloride spray |
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| Labeler - The Procter & Gamble Manufacturing Company (004238200) |