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| Product NDC Code | 0487-5901 | ||||
|---|---|---|---|---|---|
| Drug Name | S2 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | RESPIRATORY (INHALATION) | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 310133, 863968 |
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| Application Number | part341 | ||||
| Labeler Name | Nephron SC, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each 0.5 ml) Racepinephrine, USP 11.25 mg (as 13.5 mg of Racepinephrine HCl, USP).
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 The ingredient is used in an aqueous solution at a concentration equivalent to 1 percent epinephrine. Do not use more than directed For use in a hand-held rubber bulb nebulizer: Add 0.5 ml (contents of one vial) of solution to nebulizer. Adults and children 4 years of age and over: 1 to 3 inhalations not more often than every 3 hours. Do not use more than 12 inhalations in 24 hours. The use of this product by children should be supervised by an adult. Children under 4 years of age: ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Ascorbic acid, citric acid, edetate disodium, water for injection.
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 For temporary relief of mild symptoms of intermittent asthma: Wheezing Tightness of chest Shortness of breath
Purpose
Information about the drug product’s indications for use.Purpose Bronchodilator
Spl product data elements
Usually a list of ingredients in a drug product.S2 racepinephrine hydrochloride ASCORBIC ACID CITRIC ACID MONOHYDRATE EDETATE DISODIUM WATER RACEPINEPHRINE HYDROCHLORIDE RACEPINEPHRINE
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.PACKAGE LABEL, PRINCIPAL DISPLAY PANEL Principle Display - Pouch Label (Individually Wrapped Vial) NDC 0487-5901-99 Principle Display - Carton (30 Individually Wrapped Vials) NDC 0487-5901-99 Figure 01 Figure 02
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
Manufactured By: Nephron Pharmaceuticals Corporation West Columbia, SC 29172
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: Ever been hospitalized for asthma Heart disease High blood pressure Diabetes Thyroid disease Seizures Narrow angle glaucoma A psychiatric or emotional condition Trouble urinating due to an enlarged prostate gland
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are: Taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions. Taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain).
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use: Unless a doctor said you have asthma If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product. If product is brown in color or cloudy
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. In case of overdose, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-443-4313 Monday through Friday, 8:00 a.m. to 5:00 p.m. (Eastern Standard Time).
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: Your asthma is getting worse (See Asthma alert ) You have difficulty sleeping You have a rapid heartbeat You have tremors, nervousness, or seizure
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: Your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death. Your risk of heart attack or stroke increases if you: Have a history of high blood pressure or heart disease Take this product more frequently or take more than the recommended dose. Avoid foods or beverages that contain caffeine Avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect.
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 Protect from light. Avoid excessive heat. Protect from freezing. Store between 2°C and 25°C (36°F and 77°F). How Supplied: S 2 ® Racepinephrine Inhalation Solution, USP 2.25% is supplied in 0.5 ml sterile unit-of-use vials. NDC 0487-5901-99 30 vials, each vial in an individual foil pouch.
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 Asthma alert Because asthma may be life threatening, see a doctor if you: Are not better in 20 minutes Get worse Need more than 12 inhalations in 24 hours Use more than 9 inhalations in 24 hours for 3 or more days a week Have more than 2 asthma attacks in a week These may be signs that your asthma is getting worse. Do not use: Unless a doctor said you have asthma If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product. If product is brown in color or cloudy Ask a doctor before use if you have: Ever been hospitalized for asthma Heart disease High blood pressure Diabetes Thyroid disease Seizures Narrow angle glaucoma A psychiatric or emotional condition Trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are: Taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions. Taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain). Stop use and ask a doctor if: Your asthma is getting worse (See Asthma alert ) You have difficulty sleeping You have a rapid heartbeat You have tremors, nervousness, or seizure When using this product: Your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death. Your risk of heart attack or stroke increases if you: Have a history of high blood pressure or heart disease Take this product more frequently or take more than the recommended dose. Avoid foods or beverages that contain caffeine Avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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