Subpart G - SPECIFIC LABELING REQUIREMENTS FOR SPECIFIC DRUG PRODUCTS
- Section 201.300 - Notice to manufacturers, packers, and distributors of glandular preparations
- Section 201.301 - Notice to manufacturers, packers, and distributors of estrogenic hormone preparations
- Section 201.302 - Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil
- Section 201.303 - Labeling of drug preparations containing significant proportions of wintergreen oil
- Section 201.304 - Tannic acid and barium enema preparations
- Section 201.305 - Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings
- Section 201.306 - Potassium salt preparations intended for oral ingestion by man
- Section 201.307 - Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale
- Section 201.308 - Ipecac syrup; warnings and directions for use for over-the-counter sale
- Section 201.309 - Acetophenetidin (phenacetin)-containing preparations; necessary warning statement
- Section 201.310 - Phenindione; labeling of drug preparations intended for use by man
- Section 201.311 - Reserved
- Section 201.312 - Magnesium sulfate heptahydrate; label declaration on drug products
- Section 201.313 - Estradiol labeling
- Section 201.314 - Labeling of drug preparations containing salicylates
- Section 201.315 - Over-the-counter drugs for minor sore throats; suggested warning
- Section 201.316 - Drugs with thyroid hormone activity for human use; required warning
- Section 201.317 - Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning
- Section 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
- Section 201.320 - Warning statements for drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances
- Section 201.323 - Aluminum in large and small volume parenterals used in total parenteral nutrition
- Section 201.325 - Over-the-counter drugs for vaginal contraceptive and spermicide use containing nonoxynol 9 as the active ingredient; required warnings and labeling information
- Section 201.326 - Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required warnings and other labeling
- Section 201.327 - Over-the-counter sunscreen drug products; required labeling based on effectiveness testing
- Section 201.328 - [Effective 12/18/2025] Labeling of medical gas containers
- Section 201.328 - [Effective until 12/18/2025] Labeling of medical gas containers