Akorn Promethazine HYDROCHLORIDE AND CODEINE COUGH SYRUP  

Akorn Promethazine Codeine cough syrup is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. Marketed under Akorn’s Hi-Tech Pharmacal label, fruit-flavored Promethazine/Phenylep h rine Syrup is available in a 473 mL bottle. 

Active: Promethazine Hydrochloride 6.25 mg, Codeine Phosphate 10 mg, Alcohol 7%; 

Preservative: Methylparaben, Propylparaben and Sodium Benzoate ; 

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Inactives: Artificial Boysenberry Flavor, Ascorbic Acid, Citric Acid, D&C Red No. 33, FD&C Blue No. 1, FD&C Yellow No. 6, Propylene Glycol, Purified Water, Saccharin Sodium , Sodium Citrate and Sucrose Syrup. 

Product Description: Promethazine Hydrochloride and Codeine Phosphate Syrup CV 

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Description: 6.25 mg/10 mg per 5 mL Boysenberry Flavored Syrup 

Compare To: Phenergan® with Codeine 

Size: 473 mL 

Unit of Sale: 1 

Type: Rx 

Orange Book: AA 

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. 

Each Bottle contains 6.25mg of promethazine hydrochloride , 10 mg of codeine phosphate and 7% alcohol . 

Addiction, Abuse, and Misuse 

Promethazine HCl and Codeine Phosphate cough syrup exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. 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. Assess each patient’s risk prior to prescribing Promethazine HCl and Codeine Phosphate Oral Solution, prescribe Promethazine HCl and Codeine Phosphate Oral Solution for the shortest duration that is consistent with individual patient treatment goals, monitor all patients regularly for the development of addition or abuse, and refill only after reevaluation of the need for continued treatment 

Life-Threatening Respiratory Depression 
Serious, life-threatening, or fatal respiratory depression may occur with use of Promethazine HCl and Codeine Phosphate Oral Solution. Monitor for respiratory depression, especially during initiation of Promethazine HCl and Codeine Phosphate Oral Solution therapy or when used in patients at higher risk