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General Labeling Provisions

  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. General Labeling Provisions

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Section
201.1

Drugs; name and place of business of manufacturer, packer, or distributor.

Section
201.2

Drugs and devices; National Drug Code numbers.

Section
201.5

Drugs; adequate directions for use.

Section
201.6

Drugs; misleading statements.

Section
201.10

Drugs; statement of ingredients.

Section
201.15

Drugs; prominence of required label statements.

Section
201.16

Drugs; Spanish-language version of certain required statements.

Section
201.17

Drugs; location of expiration date.

Section
201.18

Drugs; significance of control numbers.

Section
201.19

Drugs; use of term “infant”.

Section
201.20

Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use.

Section
201.21

Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use.

Section
201.22

Prescription drugs containing sulfites; required warning statements.

Section
201.23

Required pediatric studies.

Section
201.24

Labeling for systemic antibacterial drug products.

Section
201.25

Bar code label requirements.

Section
201.26

Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile.

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