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This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. If you get any side effects,
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This medicine is subject to regulation by the FDA.
The manufacturer or distributor of the medicine is required to file.
The form can be filled out online on the FDA website.
The purpose is to ensure the safety and efficacy of the medicine.
The manufacturer, ingredients, potential side effects, and testing results must be reported.
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