21 CFR Subpart G - Specific Labeling Requirements for Specific Drug Products

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  1. § 201.300 Notice to manufacturers, packers, and distributors of glandular preparations.
  2. § 201.301 Notice to manufacturers, packers, and distributors of estrogenic hormone preparations.
  3. § 201.302 Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil.
  4. § 201.303 Labeling of drug preparations containing significant proportions of wintergreen oil.
  5. § 201.304 Tannic acid and barium enema preparations.
  6. § 201.305 Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings.
  7. § 201.306 Potassium salt preparations intended for oral ingestion by man.
  8. § 201.307 Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale.
  9. § 201.308 Ipecac syrup; warnings and directions for use for over-the-counter sale.
  10. § 201.309 Acetophenetidin (phenacetin)-containing preparations; necessary warning statement.
  11. § 201.310 Phenindione; labeling of drug preparations intended for use by man.
  12. § 201.311 [Reserved]
  13. § 201.312 Magnesium sulfate heptahydrate; label declaration on drug products.
  14. § 201.313 Estradiol labeling.
  15. § 201.314 Labeling of drug preparations containing salicylates.
  16. § 201.315 Over-the-counter drugs for minor sore throats; suggested warning.
  17. § 201.316 Drugs with thyroid hormone activity for human use; required warning.
  18. § 201.317 Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning.
  19. § 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.
  20. § 201.320 Warning statements for drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.
  21. § 201.323 Aluminum in large and small volume parenterals used in total parenteral nutrition.
  22. § 201.325 Over-the-counter drugs for vaginal contraceptive and spermicide use containing nonoxynol 9 as the active ingredient; required warnings and labeling information.
  23. § 201.326 Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required warnings and other labeling.
  24. § 201.327 Over-the-counter sunscreen drug products; required labeling based on effectiveness testing.
  25. § 201.328 Labeling of medical gas containers.
  26. Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA