Promethazine Hydrochloride And Dextomethorphan Hydrobromide Solution
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Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
History
There is currently no drug history available for this drug.
Other Information
Each 5 mL (one teaspoonful), for oral administration contains: dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. Alcohol 7%.
Inactive Ingredients: Ascorbic Acid, Citric Acid, Edetate Disodium, FD&C Yellow #6, Glycerin, Methylparaben, Natural & Artificial Flavors, Purified Water, Saccharin Sodium, Sodium Benzoate, Sodium Citrate, and Sucrose.
Dextromethorphan hydrobromide is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-methoxy-17-methyl-9α,13α, 14α-morphinan hydrobromide monohydrate. Dextromethorphan hydrobromide occurs as white crystals sparingly soluble in water and freely soluble in alcohol. It has a molecular weight of 370.32, a molecular formula of C18H25NO•HBr•H20, and the following structural formula:
Promethazine is a racemic compound. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as "10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-, monohydrochloride".
Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2S •HCI, and the following structural formula:
Sources
Promethazine Hydrochloride And Dextomethorphan Hydrobromide Solution Manufacturers
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Amneal Pharmaceuticals
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Promethazine Hydrochloride And Dextomethorphan Hydrobromide Solution | Amneal Pharmaceuticals
Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is contraindicated for children under 2 years of age (see WARNINGS – Black Box Warning and Use in Pediatric Patients).
The average effective dose is given in the following table:
Adults 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours Children 6 years to under 12 years ½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours, not to exceed 20 mL in 24 hours. Children 2 years to under 6 years ¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours, not to exceed 10 mL in 24 hours.
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