Promethazine VC with Codeine Oral Solution

PAI Holdings, LLC🇺🇸 United States

FDA Page

Effective Date: Jan 22, 2024
Approval ID: 75c68c3a-8d8d-4a13-87de-3eb73608c943
Products: 1 registered
Version: 4

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use PROMETHAZINE VC WITH CODEINE ORAL SOLUTION CV safely and effectively. See full prescribing information for PROMETHAZINE VC WITH CODEINE ORAL SOLUTION CV. PROMETHAZINE VC WITH CODEINE ORAL SOLUTION (promethazine hydrochloride, phenylephrine hydrochloride, and codeine phosphate) oral solution, CV Initial U.S. Approval: 1952

Quick Stats

Total Products1

Labelers2

Label Sections19

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.