FDA approval is mandatory requirement for new drugs, FDA approve drug products only after strict evaluation of documents, test results, clinical studies, protocol, and site inspection. Drug products in OTC Monograph does not require FDA approval.
DO NOT USE THIS PRODUCT IN THE FOLLOWING SITUATIONS:
• Are under the legal age of purchase
• Are pregnant or breastfeeding
• Have heart disease, stomach or duodenal ulcers, liver or kidney problems, throat disease, or difficulty breathing due to bronchitis, emphysema, or asthma
• Have an overactive thyroid or pheochromocytoma a tumor of the adrenal gland that can affect blood pressure)
• Are taking certain medications, such as theophylline, ropinirole, or clozapine .