The following Structured Product Label (SPL) was submitted to the FDA by Directrx for the product Losartan Potassium (NDC 61919-461). 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 boxed warning, description, clinical pharmacology, clinical pharmacology continued, indications and usage, contraindications, warnings, precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
fetal toxicity
When pregnancy is detected, discontinue losartan potassium tablets as soon as possible.
Drugs that act directly on the rennin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS, Fetal Toxicity.
Label (Losartanpot461)
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