Promethazine HCl (Hi tech codeine) and codeine phosphate oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.
Important Limitations of Use:
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- Not indicated for pediatric patients under 18 years of age [see USE IN SPECIFIC POPULATIONS (8.4)].
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- Contraindicated in pediatric patients under 12 years of age [see CONTRAINDICATIONS (4), USE IN SPECIFIC POPULATIONS (8.4)].
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- Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see CONTRAINDICATIONS (4), USE IN SPECIFIC POPULATIONS (8.4)].
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- Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see WARNINGS AND PRECAUTIONS (5.1)], reserve promethazine HCl and codeine phosphate oral solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.
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Promethazine HCl (Hi tech codeine) and Codeine Phosphate Oral Solution contains codeine, an opioid agonist, and promethazine, a phenothiazine.
Each 5 mL of Promethazine HCl and Codeine Phosphate Oral Solution contains 10 mg of codeine phosphate and 6.25 mg of promethazine hydrochloride for oral administration.
Promethazine HCl and Codeine Phosphate Oral Solution has a pH between 4.3 and 5.3 and contains alcohol 7%.
Promethazine HCl and Codeine Phosphate Oral Solution also contains the following inactive ingredients: Artificial boysenberry flavor, ascorbic acid, citric acid, D&C Red No. 33, FD&C Blue No. 1, FD&C Yellow No. 6, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate, and sucrose syrup.
The chemical name for codeine phosphate is 7,8-Didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate. Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy, it is classified pharmacologically as a narcotic analgesic. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. The molecular weight is 406.37. Its molecular formula is C18H21NO3•H3PO4 • ½ H2O, and it has the following chemical structure.
Promethazine Hydrochloride
The chemical name for promethazine hydrochloride, a phenothiazine derivative, is (±)-10-[2-(Dimethylamino)propyl] phenothiazine 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. The molecular weight is 320.88. Its molecular formula is C17H20N2S•HCl, and it has the following chemical structure.
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