C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER C—DRUGS: GENERAL › PART 201—LABELING › Subpart C—Labeling Requirements for Over-the-Counter Drugs

21 C.F.R. § 201.63

Pregnancy/breast-feeding warning

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(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 of this chapter, the specific warning shall be used in place of the warning in paragraph (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) of this section where appropriate upon petition under the provisions of § 10.30 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) of this section. The warning shall be as follows:

“It is especially important not to use” (select “aspirin” or “carbaspirin calcium,” as appropriate) “during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.”

[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]
Notes of Decisions
Cited in 4 cases (2 in the last 5 years), 1993–2023 · leading case: Ramirez v. Plough, Inc., 863 P.2d 167 (Cal. 1993).
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Ramirez v. Plough, Inc., 863 P.2d 167 (Cal. 1993). · cites it 2× “( 21 C.F.R. § 201.63 (a) (1993).) Aspirin products must carry an additional warning against use during the last three months of pregnancy.”
Hatfield v. Wal-Mart Stores, Inc. (S.D.N.Y. 2022). · cites it 5× “21 C.F.R. § 201.63 . A brief history of the Pregnancy Warning provides context to this regulation.”
Chapman v. Walmart Inc. (S.D.N.Y. 2023). · cites it 2× “The preemptive effect of the pregnancy warning regulation, 21 C.F.R. § 201.63 , has not been addressed by other courts.”
Emley v. Wal-mart Stores, Inc. (S.D. Ind. 2020). “322 ), or during pregnancy ( 21 C.F.R. § 201.63 ), or with children under age three ( 21 C.”
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