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(hydrochloride tablets, USP) Rx only HAS A HIGH POTENTIAL FOR ABUSE. IT SHOULD THUS BE TRIED ONLY REDUCTION PROGRAMS FOR PATIENTS IN WHOM ALTERNATIVE THERAPY HAS BEEN INEFFECTIVE. ADMINISTRATION OF
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label - accessdata fda refers to the labeling information submitted to the FDA for approval of a new drug.
The manufacturer or sponsor of a new drug is required to file label - accessdata fda.
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Information such as drug name, active ingredients, indications, contraindications, dosage and administration instructions, warnings, precautions, and adverse reactions must be reported on label - accessdata fda.
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