Opium
FDA Label NDC 10191-1082

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Remedy Makers for the product Opium (NDC 10191-1082). 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 other, warning:, indication:, directions (adult/children), inactive ingredients:, questions or comments:, other information:, caution:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Warning:

→ Indication:

→ Directions (adult/children)

→ Inactive Ingredients:

→ Questions Or Comments:

→ Other Information:

→ Caution:

→ Package Label.principal Display Panel

Other

CII

Warning:

"The FDA has not deternined that this product is safe, effective and not misbranded for its intended use".

Use only if cap and seal are unbroken. Keep this and all medication out of reach of children. If symptoms persist more than 3 days or worsen, discontinue (STOP) use and consult your physician. As with any drug. If you are pregnant or nursing (breast-feeding) a baby, seek the advise of a health professional before using this product. Store tightly closed in a cool area.