Title 21

PART 201 SUBPART G

Subpart G - Specific Labeling Requirements for Specific Drug Products

21:4.0.1.1.2.7.1.1SECTION 201.300
   201.300 Notice to manufacturers, packers, and distributors of glandular preparations.
21:4.0.1.1.2.7.1.2SECTION 201.301
   201.301 Notice to manufacturers, packers, and distributors of estrogenic hormone preparations.
21:4.0.1.1.2.7.1.3SECTION 201.302
   201.302 Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil.
21:4.0.1.1.2.7.1.4SECTION 201.303
   201.303 Labeling of drug preparations containing significant proportions of wintergreen oil.
21:4.0.1.1.2.7.1.5SECTION 201.304
   201.304 Tannic acid and barium enema preparations.
21:4.0.1.1.2.7.1.6SECTION 201.305
   201.305 Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings.
21:4.0.1.1.2.7.1.7SECTION 201.306
   201.306 Potassium salt preparations intended for oral ingestion by man.
21:4.0.1.1.2.7.1.8SECTION 201.307
   201.307 Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale.
21:4.0.1.1.2.7.1.9SECTION 201.308
   201.308 Ipecac syrup; warnings and directions for use for over-the-counter sale.
21:4.0.1.1.2.7.1.10SECTION 201.309
   201.309 Acetophenetidin (phenacetin)-containing preparations; necessary warning statement.
21:4.0.1.1.2.7.1.11SECTION 201.310
   201.310 Phenindione; labeling of drug preparations intended for use by man.
21:4.0.1.1.2.7.1.12SECTION 201.311
   201.311 [Reserved]
21:4.0.1.1.2.7.1.13SECTION 201.312
   201.312 Magnesium sulfate heptahydrate; label declaration on drug products.
21:4.0.1.1.2.7.1.14SECTION 201.313
   201.313 Estradiol labeling.
21:4.0.1.1.2.7.1.15SECTION 201.314
   201.314 Labeling of drug preparations containing salicylates.
21:4.0.1.1.2.7.1.16SECTION 201.315
   201.315 Over-the-counter drugs for minor sore throats; suggested warning.
21:4.0.1.1.2.7.1.17SECTION 201.316
   201.316 Drugs with thyroid hormone activity for human use; required warning.
21:4.0.1.1.2.7.1.18SECTION 201.317
   201.317 Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning.
21:4.0.1.1.2.7.1.19SECTION 201.319
   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.
21:4.0.1.1.2.7.1.20SECTION 201.320
   201.320 Warning statements for drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.
21:4.0.1.1.2.7.1.21SECTION 201.323
   201.323 Aluminum in large and small volume parenterals used in total parenteral nutrition.
21:4.0.1.1.2.7.1.22SECTION 201.325
   201.325 Over-the-counter drugs for vaginal contraceptive and spermicide use containing nonoxynol 9 as the active ingredient; required warnings and labeling information.
21:4.0.1.1.2.7.1.23SECTION 201.326
   201.326 Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required warnings and other labeling.
21:4.0.1.1.2.7.1.24SECTION 201.327
   201.327 Over-the-counter sunscreen drug products; required labeling based on effectiveness testing.
21:4.0.1.1.2.7.1.25SECTION 201.328
   201.328 Labeling of medical gas containers.
21:4.0.1.1.2.7.1.26.1APPENDIX Appendix A
   Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA