![S2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [CARDINAL HEALTH]](https://medic.hrt.org//dailymed/images/fc1acb1d-81bd-4ccf-9a43-61e697cce15d/image-01.jpg)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 0.5 ml)
- Purpose
- Uses
For temporary relief of mild symptoms of intermittent asthma:
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- Wheezing
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- Tightness of chest
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- Shortness of breath
- Warnings
Asthma alert
Because asthma may be life threatening, see a doctor if you:
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- Are not better in 20 minutes
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- Get worse
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- Need more than 12 inhalations in 24 hours
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- Use more than 9 inhalations in 24 hours for 3 or more days a week
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- Have more than 2 asthma attacks in a week
These may be signs that your asthma is getting worse.
Do not use:
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- Unless a doctor said you have asthma
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- 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.
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- If product is brown in color or cloudy
Ask a doctor before use if you have:
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- Ever been hospitalized for asthma
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- Heart disease
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- High blood pressure
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- Diabetes
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- Thyroid disease
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- Seizures
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- Narrow angle glaucoma
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- A psychiatric or emotional condition
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- Trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are:
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- Taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions.
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- 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:
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- Your asthma is getting worse (See Asthma alert)
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- You have difficulty sleeping
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- You have a rapid heartbeat
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- 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:
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- Have a history of high blood pressure or heart disease
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- Take this product more frequently or take more than the recommended dose.
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- Avoid foods or beverages that contain caffeine
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- Avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect.
Close- •
- Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- Directions
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- The ingredient is used in an aqueous solution at a concentration equivalent to 1 percent epinephrine.
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- Do not use more than directed
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-
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.
- Other Information
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- Protect from light. Avoid excessive heat. Protect from freezing.
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- Store between 2°C and 25°C (36°F and 77°F).
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-
How Supplied: S
2
® Racepinephrine Inhalation Solution, USP 2.25% is supplied in 0.5 ml sterile unit-of-use vials.
Available overbagged with 1 x 0.5 mL Sterile Unit-Of-Use Vial, each vial in an individual foil pouch, NDC 55154-4352-8
- Inactive Ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
Manufactured By:
nephron pharmaceuticals corporation
Orlando, FL 32811Repackaged By:
Cardinal Health
Zanesville, OH 43701
LA6745-11016
LA6745-21016
Close - Principal Display Panel
S2
Racepinephrine Inhalation Solution, USP 2.25%
Bronchodilator
1 x 0.5 mL Sterile Unit-of-use Vial
Each in a foil pouch
Close - INGREDIENTS AND APPEARANCE
S2
racepinephrine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-4352(NDC:0487-5901) Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RACEPINEPHRINE HYDROCHLORIDE (UNII: 336096P2WE) (RACEPINEPHRINE - UNII:GR0L9S3J0F) RACEPINEPHRINE 11.25 mg in .5 mL Inactive Ingredients Ingredient Name Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55154-4352-8 1 in 1 BAG 01/01/2000 1 1 in 1 POUCH 1 .5 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/2000 Labeler - Cardinal Health (188557102) Registrant - Nephron Pharmaceuticals Corporation (783905201) CloseEstablishment Name Address ID/FEI Business Operations Cardinal Health 188557102 REPACK(55154-4352)
