U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 28, 2025

All TitlesTitle 21Chapter IPart 201Subpart G - Subpart G—Specific Labeling Requirements for Specific Drug Products
§ 201.300 - Notice to manufacturers, packers, and distributors of glandular preparations.
§ 201.301 - Notice to manufacturers, packers, and distributors of estrogenic hormone preparations.
§ 201.302 - Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil.
§ 201.303 - Labeling of drug preparations containing significant proportions of wintergreen oil.
§ 201.304 - Tannic acid and barium enema preparations.
§ 201.305 - Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings.
§ 201.306 - Potassium salt preparations intended for oral ingestion by man.
§ 201.307 - Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale.
§ 201.308 - Ipecac syrup; warnings and directions for use for over-the-counter sale.
§ 201.309 - Acetophenetidin (phenacetin)-containing preparations; necessary warning statement.
§ 201.310 - Phenindione; labeling of drug preparations intended for use by man.
§ 201.311 - [Reserved]
§ 201.312 - Magnesium sulfate heptahydrate; label declaration on drug products.
§ 201.313 - Estradiol labeling.
§ 201.314 - Labeling of drug preparations containing salicylates.
§ 201.315 - Over-the-counter drugs for minor sore throats; suggested warning.
§ 201.316 - Drugs with thyroid hormone activity for human use; required warning.
§ 201.317 - Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning.
§ 201.319 - Water-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.
§ 201.320 - Warning statements for drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.
§ 201.323 - Aluminum in large and small volume parenterals used in total parenteral nutrition.
§ 201.325 - Over-the-counter drugs for vaginal contraceptive and spermicide use containing nonoxynol 9 as the active ingredient; required warnings and labeling information.
§ 201.326 - Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required warnings and other labeling.
§ 201.327 - Over-the-counter sunscreen drug products; required labeling based on effectiveness testing.
§ 201.328 - Labeling of medical gas containers.
Appendix Appendix A - Appendix A to Part 201—Examples of Graphic Enhancements Used by FDA
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