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IN THE COURT OF COUNTY STATE OF)))Petitioner/Plaintiff, )))NO. Vs. )))Respondent/Defendant))AMENDED COMPLAINTCOME NOW plaintiffs and, through counsel, and file this Amended Complaint against and in.
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Amended complaint court FAQ
A package insert is a document included in the package of a medication that provides information about that drug and its use. For prescription medications, the insert is technical, providing information for medical professionals about how to prescribe the drug.
FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.
FDA regulations require that all medication labels include: Name of Product. Table of Drug Facts. Active Ingredients. Proper Use and Purpose.
The product's active ingredients, including the amount in each dosage unit. The purpose of the product. The uses (indications) for the product. Specific warnings, including when the product should not be used under any circumstances, and when it is appropriate to consult with a doctor or pharmacist.
The Federal Food, Drug, and Cosmetic Act authorizes FDA to require that prescription drug labeling provides healthcare professionals and patients with adequate information to permit safe and effective use of drug products.
Medication Guides include information about the medicine, how to take the medicine, who should not take the medicine, serious side effects of the medicine, and common side effects of the medicine. A Medication Guide must be provided to the patient whenever the medicine is dispensed.
What is the Prescribing Information? FDA-approved Prescribing Information (PI), also known as United States Prescribing Information (USPI), reflects FDA's finding regarding the safety and effectiveness of the human prescription drug under the labeled conditions of use.
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