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Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency's principal means of achieving prompt voluntary compliance with the Act. [1]
Metronidazole in combination with alcohol causes severe reactions such as vomiting and flushes in many patients. Tetracycline resorption is reduced by dairy products, antacids and other products containing calcium , magnesium , aluminium as well as iron .
In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears near the beginning of the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text [1] to emphasize its ...
Metronidazole, sold under the brand name Flagyl among others, is an antibiotic and antiprotozoal medication. [10] It is used either alone or with other antibiotics to treat pelvic inflammatory disease, endocarditis, and bacterial vaginosis. [10] It is effective for dracunculiasis, giardiasis, trichomoniasis, and amebiasis. [10]
a signal word – either Danger or Warning – where necessary; hazard statements, indicating the nature and degree of the risks posed by the product; the identity of the supplier (who might be a manufacturer or importer) Each precautionary statement is designated a code, starting with the letter P and followed by three digits.
An auxiliary label (also called cautionary and advisory label or prescription drug warning label) is a label added on to a dispensed medication package by a pharmacist in addition to the usual prescription label. These labels are intended to provide supplementary information regarding the safe administration, use, and storage of the medication. [1]
The warning to healthcare providers followed the company's recall over incompatibility concerns with syringe pumps. (Reporting by Pratik Jain in Bengaluru; Editing by Shilpi Majumdar and Sriraj ...
Warning label on a cigarette box: "Smoking Kills". Warning label for a personal water craft. A warning label is a label attached to a product, or contained in a product's instruction manual, warning the user about risks associated with its use, and may include restrictions by the manufacturer or seller on certain uses. [1]