21 CFR Subpart G
Specific Labeling Requirements for Specific Drug Products
June 25, 2020
§
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