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NDC 65162-0694-90 Promethazine HCl, Phenylephrine HCl, Codeine Phosphate 10; 5; 6.25 mg/5mL; mg/5mL; mg/5mL Details

Promethazine HCl, Phenylephrine HCl, Codeine Phosphate 10; 5; 6.25 mg/5mL; mg/5mL; mg/5mL

Promethazine HCl, Phenylephrine HCl, Codeine Phosphate is a ORAL SYRUP in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Codeine is used to relieve mild to moderate pain. It is also used, usually in combination with other medications, to reduce coughing. Codeine will help relieve symptoms but will not treat the cause of symptoms or speed recovery. Codeine belongs to a class of medications called opiate (narcotic) analgesics and to a class of medications called antitussives. When codeine is used to treat pain, it works by changing the way the brain and nervous system respond to pain. When codeine is used to reduce coughing, it works by decreasing the activity in the part of the brain that causes coughing. Codeine is also available in combination with acetaminophen (Capital and Codeine, Tylenol with Codeine), aspirin, carisoprodol, and promethazine and as an ingredient in many cough and cold medications. This monograph only includes information about the use of codeine. If you are taking a codeine combination product, be sure to read information about all the ingredients in the product you are taking and ask your doctor or pharmacist for more information.

Related Packages: 65162-0694-90
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Codeine

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Related Packages: 65162-0694-90
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine

Promethazine is used to relieve the symptoms of allergic reactions such as allergic rhinitis (runny nose and watery eyes caused by allergy to pollen, mold or dust), allergic conjunctivitis (red, watery eyes caused by allergies), allergic skin reactions, and allergic reactions to blood or plasma products. Promethazine is used with other medications to treat anaphylaxis (sudden, severe allergic reactions) and the symptoms of the common cold such as sneezing, cough, and runny nose. Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times. Promethazine is also used to prevent and control nausea and vomiting that may occur after surgery, and with other medications to help relieve pain after surgery. Promethazine is also used to prevent and treat motion sickness. Promethazine helps control symptoms, but will not treat the cause of the symptoms or speed recovery. Promethazine is in a class of medications called phenothiazines. It works by blocking the action of a certain natural substance in the body.

Related Packages: 65162-0694-90
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Promethazine

Product Information

NDC	65162-0694
Product ID	65162-694_8a7ce8a7-d7ca-4e9f-b5ba-bcbfb6dfe09d
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Promethazine HCl, Phenylephrine HCl, Codeine Phosphate
Proprietary Name Suffix	n/a
Non-Proprietary Name	Promethazine, Phenylephrine, Codeine
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	SYRUP
Route	ORAL
Active Ingredient Strength	10; 5; 6.25
Active Ingredient Units	mg/5mL; mg/5mL; mg/5mL
Substance Name	CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Labeler Name	Amneal Pharmaceuticals LLC
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC]
DEA Schedule	CV
Marketing Category	ANDA
Application Number	ANDA200963
Listing Certified Through	2024-12-31

Package

NDC 65162-0694-90 (65162069490)

Pricing Information	N/A
NDC Package Code	65162-694-90
Billing NDC	65162069490
Package	473 mL in 1 BOTTLE (65162-694-90)
Marketing Start Date	2013-11-01
NDC Exclude Flag	N