Codeine-guaifenesin Solution
FDA Label NDC 58657-500

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Method Pharmaceuticals, Llc for the product Codeine-guaifenesin (NDC 58657-500). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, ask your doctor before use if, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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