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| Product NDC Code | 64336-170 | ||||
|---|---|---|---|---|---|
| Drug Name | Vicks sinex severe original |
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| Type | Brand | ||||
| Pharm Class | Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC] |
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| Active Ingredients |
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| Route | NASAL | ||||
| Dosage Form | SPRAY | ||||
| RxCUI drug identifier | 1000990, 1001066 |
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| Application Number | M012 | ||||
| Labeler Name | Procter & Gamble Manufacturing GmbH | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Oxymetazoline HCl 0.05%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions 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
| 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 |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzalkonium chloride, benzyl alcohol, citric acid anhydrous, edetate disodium, fragrance, polysorbate 80, propylene glycol, purified water, sodium citrate
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses temporarily relieves nasal congestion due to a cold, hay fever, or other upper respiratory allergies sinus congestion and pressure
Purpose
Information about the drug product’s indications for use.Purpose Nasal decongestant
Spl product data elements
Usually a list of ingredients in a drug product.Vicks Sinex Severe Original Oxymetazoline Hydrochloride PROPYLENE GLYCOL BENZALKONIUM CHLORIDE BENZYL ALCOHOL ANHYDROUS CITRIC ACID EDETATE DISODIUM POLYSORBATE 80 WATER SODIUM CITRATE OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE Clear
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 15 ml Bottle Carton VICKS ® Sinex™ SEVERE Oxymetazoline HCl Nasal Decongestant ORIGNAL NASAL SPRAY Fast Sinus Congestion & Pressure Relief Powerful Vicks Vapors 12 HOUR ½ FL OZ (15 ml) SSS
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
If swallowed, get medical help or contact a Poison Control Center right away
TAMPER EVIDENT: Carton sealed for your protection.
MADE IN GERMANY DIST. BY PROCTER & GAMBLE, CINCINNATI OH 45202
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have heart disease thyroid disease diabetes high blood pressure trouble urinating due to enlarged prostate gland
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-873-8276
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if symptoms persist.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information do not exceed 25ºC
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Ask a doctor before use if you have heart disease thyroid disease diabetes high blood pressure trouble urinating due to enlarged prostate gland
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API