PocketLaw | CFR 21 | Specific Labeling Requirements for Specific Drug

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

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

Specific Labeling Requirements for Specific Drug Products

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Notice to manufacturers, packers, and distributors of glandular preparations.

Notice to manufacturers, packers, and distributors of estrogenic hormone preparations.

Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil.

Labeling of drug preparations containing significant proportions of wintergreen oil.

Tannic acid and barium enema preparations.

Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings.

Potassium salt preparations intended for oral ingestion by man.

Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale.

Ipecac syrup; warnings and directions for use for over-the-counter sale.

Acetophenetidin (phenacetin)-containing preparations; necessary warning statement.

Phenindione; labeling of drug preparations intended for use by man.

§ 201.311 [Reserved]

Magnesium sulfate heptahydrate; label declaration on drug products.

Estradiol labeling.

Labeling of drug preparations containing salicylates.

Over-the-counter drugs for minor sore throats; suggested warning.

Drugs with thyroid hormone activity for human use; required warning.

Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning.

Warning statements for drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.

Aluminum in large and small volume parenterals used in total parenteral nutrition.

Over-the-counter drugs for vaginal contraceptive and spermicide use containing nonoxynol 9 as the active ingredient; required warnings and labeling information.

Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required warnings and other labeling.

Over-the-counter sunscreen drug products; required labeling based on effectiveness testing.

Labeling of medical gas containers.