SPL documents contain both the content of labeling (all text, tables and figures) for a product along with additional machine readable information (including drug listing data elements and clinical data elements). Drug listing data elements include coded information about the product (including product and generic names, ingredients, ingredient strengths, dosage forms, routes of administration, appearance, DEA schedule) and the packaging (package quantity and type). Clinical data elements include coded information about the clinical use of the product (including indications and use, contraindications, drug interactions, warning and precautions and use in special populations).
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