Specific Labeling Requirements for Specific Drug Products | MidpageSpecific Labeling Requirements for Specific Drug Products
201.300Notice to manufacturers, packers, and distributors of glandular preparations.201.301Notice to manufacturers, packers, and distributors of estrogenic hormone preparations.201.302Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil.201.303Labeling of drug preparations containing significant proportions of wintergreen oil.201.304Tannic acid and barium enema preparations.201.305Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings.201.306Potassium salt preparations intended for oral ingestion by man.201.307Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale.201.308Ipecac syrup; warnings and directions for use for over-the-counter sale.201.309Acetophenetidin (phenacetin)-containing preparations; necessary warning statement.201.310Phenindione; labeling of drug preparations intended for use by man.201.311[Reserved]201.312Magnesium sulfate heptahydrate; label declaration on drug products.201.313Estradiol labeling.201.314Labeling of drug preparations containing salicylates.201.315Over-the-counter drugs for minor sore throats; suggested warning.201.316Drugs with thyroid hormone activity for human use; required warning.201.317Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning.201.319Water-soluble gums, hydrophilic gums, and hydrophilic mucilloids (including, but not limited to agar, alginic acid, calcium polycarbophil, carboxymethylcellulose sodium, carrageenan, chondrus, glucomannan ((B-1,4 linked) polymannose acetate), guar gum, karaya gum, kelp, methylcellulose, plantago seed (psyllium), polycarbophil tragacanth, and xanthan gum) as active ingredients; required warnings and directions.201.320Warning statements for drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.201.323Aluminum in large and small volume parenterals used in total parenteral nutrition.201.325Over-the-counter drugs for vaginal contraceptive and spermicide use containing nonoxynol 9 as the active ingredient; required warnings and labeling information.201.326Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required warnings and other labeling.201.327Over-the-counter sunscreen drug products; required labeling based on effectiveness testing.201.328Labeling of medical gas containers.