Paracetamol + Codeine Tablets

Form: Tablets

Strength: 300 mg paracetamol + 30 mg codeine; 300 mg + 60 mg

Reference Brands: Tylenol with Codeine(US)

Category: Analgesic

Paracetamol + Codeine tablets are approved in the EU and US for moderate pain relief. In the US, brands like Tylenol with Codeine are regulated by the DEA as Schedule II controlled substances, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the EU, regulations vary by country, with strict control measures for codeine-containing products. Both regions require detailed dossiers, clinical data, and pharmacovigilance plans for initial approval and ongoing safety. To ensure compliance, navigate complex regulations, and facilitate market access, visit PharmaTradz. We support seamless registration and compliance for paracetamol + codeine formulations, ensuring adherence to European and American standards for safe, effective pain management.