---
kind: "section"
citation: "21 C.F.R. § 201.63"
title: "21"
number: "201.63"
heading: "Pregnancy/breast-feeding warning."
url: "https://uscodex.org/cfr/21/201.63"
---

# §201.63. Pregnancy/breast-feeding warning.

- (a) The labeling for all over-the-counter (OTC) drug products that are intended for systemic absorption, unless specifically exempted, shall contain a general warning under the heading “Warning” (or “Warnings” if it appears with additional warning statements) as follows: “If pregnant or breast-feeding, ask a health professional before use.” [first four words of this statement in bold type] In addition to the written warning, a symbol that conveys the intent of the warning may be used in labeling.
- (b) Where a specific warning relating to use during pregnancy or while nursing has been established for a particular drug product in a new drug application (NDA) or for a product covered by an OTC drug final monograph in [part 330](/cfr/21/part330.md) of this chapter, the specific warning shall be used in place of the warning in [paragraph (a)](#a) of this section, unless otherwise stated in the NDA or in the final OTC drug monograph.
- (c) **The following OTC drugs are exempt from the provisions of paragraph (a) of this section—**
  - (1) Drugs that are intended to benefit the fetus or nursing infant during the period of pregnancy or nursing.
  - (2) **Drugs that are labeled exclusively for pediatric use.**
- (d) The Food and Drug Administration will grant an exemption from [paragraph (a)](#a) of this section where appropriate upon petition under the provisions of [§ 10.30](/cfr/21/10.30.md) of this chapter. Decisions with respect to requests for exemptions shall be maintained in a permanent file for public review by the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
- (e) The labeling of orally or rectally administered OTC aspirin and aspirin-containing drug products must bear a warning that immediately follows the general warning identified in [paragraph (a)](#a) of this section. The warning shall be as follows:

## Notes

### Amendments

[47 FR 54757, Dec. 3, 1982, as amended at 55 FR 27784, July 5, 1990; 59 FR 14364, Mar. 28, 1994; 64 FR 13286, Mar. 17, 1999; 68 FR 24879, May 9, 2003; 88 FR 45065, July 14, 2023]

### Source

Source: 41 FR 6908, Feb. 13, 1976, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 321, 331, 343, 351, 352, 353, 355, 358, 360, 360b, 360ccc, 360ccc-1, 360ddd, 360ddd-1, 360ee, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.

### Source

Source: 40 FR 13998, Mar. 27, 1975, unless otherwise noted.

### Amendments

[47 FR 54757, Dec. 3, 1982, as amended at 55 FR 27784, July 5, 1990; 59 FR 14364, Mar. 28, 1994; 64 FR 13286, Mar. 17, 1999; 68 FR 24879, May 9, 2003; 88 FR 45065, July 14, 2023]