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NDC 65162-0679-86 Promethazine Hydrochloride and Phenylephrine Hydrochloride 5; 6.25 mg/5mL; mg/5mL Details
Promethazine Hydrochloride and Phenylephrine Hydrochloride 5; 6.25 mg/5mL; mg/5mL
Promethazine Hydrochloride and Phenylephrine Hydrochloride is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE.
MedlinePlus Drug Summary
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: 65162-0679-86Last 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: 65162-0679-86Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Promethazine
Product Information
| NDC | 65162-0679 |
|---|---|
| Product ID | 65162-679_1af3eeac-303f-4e30-91ac-0c53e7278f31 |
| 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 Hydrochloride and Phenylephrine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Promethazine and Phenylephrine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 5; 6.25 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA040902 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65162-0679-86 (65162067986)
| NDC Package Code | 65162-679-86 |
|---|---|
| Billing NDC | 65162067986 |
| Package | 118 mL in 1 BOTTLE (65162-679-86) |
| Marketing Start Date | 2009-08-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |