Each mL contains 10 mg Adrenalin (epinephrine) as the hydrochloride, dissolved in sodium chloride-citrate buffer solution with 0.2 mg Phemerol® (benzethonium chloride) as a preservative and not more than 0.2% sodium bisulfite as an antioxidant.
For temporary relief of shortness of breath, tightness of chest, and wheezing due to bronchial asthma. The inhalation of Adrenalin Chloride Solution 1:100 eases breathing for asthma patients by reducing spasms of bronchial muscles.
Adrenalin Chloride Solution 1:100 is supplied for use by oral (not nasal) inhalation only. Because of the relatively high concentration, Adrenalin Chloride Solution 1:100 is not suitable for hypodermic injection.
Do not use this product unless a diagnosis of asthma has been made by a physician.
Do not use this product if you have heart disease, high blood pressure, thyroid disease, or difficulty in urination due to enlargement of the prostate gland unless directed by a physician. Do not use this product if you have ever been hospitalized for asthma or if you are taking any prescription drug for asthma unless directed by a physician.
Drug interaction precaution: Do not use this product if you are presently taking a prescription drug for high blood pressure or depression without first consulting your physician.
Do not use this product more frequently or at higher doses than recommended unless directed by a physician. Excessive use may cause nervousness and rapid heart beat and, possibly, adverse effects on the heart.
Do not continue to use this product but seek medical assistance immediately if symptoms are not relieved within 20 minutes or become worse.
Do not use the inhalation solution if it is pinkish or darker than slightly yellow or if it contains a precipitate.
As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.
For relief of bronchial congestion in asthma, Adrenalin Chloride Solution 1:100 should be applied with a glass or plastic nebulizer capable of delivering a very fine spray, and which will work with a very small amount of solution.
Approximately 10 drops (not more) of Adrenalin Chloride Solution 1:100 are placed in the reservoir of the nebulizer, the nozzle of which is placed just inside the partially opened mouth. As the bulb is squeezed once or twice the patient inhales deeply, drawing the vaporized solution into the lungs. Treatment should be started at the first symptoms. Rinsing the mouth with water immediately after using Adrenalin Chloride Solution 1:100 will help prevent the sensation of dryness of mouth and throat which may otherwise follow.
Inhalation dosage of adults, children, and adolescents 4 years of age and older: 1 to 3 inhalations not more often than every 3 hours. The use of this product by children and adolescents should be supervised by an adult.
Pediatric patients under 4 years of age: Consult a physician.
When the nebulizer contains any liquid and is not in use, it should be stoppered and kept in an upright position. Because of oxidation, Adrenalin Chloride Solution 1:100 will turn pink to brown when exposed to air. Light, heat, alkalies, and certain metals (eg, copper, iron, zinc) will also promote deterioration. A discolored inhalation solution or one containing a precipitate should not be used.
NDC 61570-301-41 Adrenalin Chloride Solution 1:100 (Epinephrine Inhalation Solution, USP), for oral inhalation use. Supplied in bottles containing 1/4 fluid ounce (7.5 mL) each.
Store between 15° and 25°C (59° and 77°F). Protect from light and freezing.
Rx only.
Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620
Manufactured by: Parkedale Pharmaceuticals, Inc., Rochester, MI 48307
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Copyright © 1999 Monarch Pharmaceuticals