Specific Labeling Requirements for Specific Drug Products

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Drugs: General
  6. Labeling
  7. Specific Labeling Requirements for Specific Drug Products

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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

§ 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

Labeling of medical gas containers.