[Code of Federal Regulations] [Title 21, Volume 4] [Revised as of April 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR201.64] [Page 40-42] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 201_LABELING--Table of Contents Subpart C_Labeling Requirements for Over-the-Counter Drugs Sec. 201.64 Sodium labeling. (a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the sodium content per dosage unit (e.g., tablet, teaspoonful) if the sodium content of a single recommended dose of the product (which may be one or more dosage units) is 5 milligrams or more. OTC drug products intended for oral ingestion include gum and lozenge dosage forms, but do not include dentifrices, mouthwashes, or mouth rinses. (b) The sodium content shall be expressed in milligrams per dosage unit and shall include the total amount of sodium regardless of the source, i.e., from both active and inactive ingredients. The sodium content shall be rounded-off to the nearest whole number. The sodium content per dosage unit shall follow the heading ``Other information'' as stated in Sec. 201.66(c)(7). (c) The labeling of OTC drug products intended for oral ingestion shall contain the following warning under the heading ``Warning'' (or ``Warnings'' if it appears with additional warning statements) if the amount of sodium present in the labeled maximum daily [[Page 41]] dose of the product is more than 140 milligrams: ``Do not use this product if you are on a sodium-restricted diet unless directed by a doctor.'' (d) The term sodium free may be used in the labeling of OTC drug products intended for oral ingestion if the amount of sodium in the labeled maximum daily dose is 0 milligram. For example, a product containing 0.4 (rounded-off to zero (0)) milligram sodium per tablet with directions to take one tablet daily may use the term ``sodium free'' in its labeling. However, when the recommended dose provides for taking more than one dosage unit per day, e.g., take one or two tablets, or take two tablets, the same product containing 0.4 milligram sodium per tablet shall not use the term ``sodium free'' because the labeled maximum daily dose contains 0.8 milligram sodium. (e) The term very low sodium may be used in the labeling of OTC drug products intended for oral ingestion if the amount of sodium in the labeled maximum daily dose is 35 milligrams or less. (f) The term low sodium may be used in the labeling of OTC drug products intended for oral ingestion if the amount of sodium in the labeled maximum daily dose is 140 milligrams or less. (g) The term salt is not synonymous with the term sodium and shall not be used interchangeably or substituted for the term sodium. (h) The terms sodium free, very low sodium, and low sodium shall be in print size and style no larger than the product's statement of identity and shall not be unduly prominent in print size or style compared to the statement of identity. (i) Any product subject to this paragraph that contains sodium bicarbonate, sodium phosphate, or sodium biphosphate as an active ingredient for oral ingestion and that is not labeled as required by this paragraph and that is initially introduced or initially delivered for introduction into interstate commerce after April 22, 1997, is misbranded under sections 201(n) and 502 (a) and (f) of the Federal Food, Drug, and Cosmetic Act (the act). [61 FR 17806, Apr. 22, 1996, as amended at 62 FR 19925, Apr. 24, 1997; 64 FR 13286, Mar. 17, 1999] Effective Date Note: At 62 FR 19925, Apr. 24, 1997, the effective date for Sec. 201.64 (a) through (h) was delayed until further notice. At 69 FR 13717, Mar. 24, 2004, the effectiveness of paragraphs (a) through (h) was further delayed until Apr. 23, 2004. Effective Date Note: At 69 FR 13724, Mar. 24, 2004, Sec. 201.64 was amended by revising paragraphs (a), (c), and (d) and by adding paragraph (j), effective Apr. 23, 2004. For the convenience of the user, the revised and added text is set forth as follows: Sec. 201.64 Sodium labeling. (a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the sodium content per dosage unit (e.g., tablet, teaspoonful) if the sodium content of a single maximum recommended dose of the product (which may be one or more dosage units) is 5 milligrams or more. OTC drug products intended for oral ingestion include gum and lozenge dosage forms, but do not include dentifrices, mouthwashes, or mouth rinses. * * * * * (c) The labeling of OTC drug products intended for oral ingestion shall contain the following statement under the heading ``Warning'' (or ``Warnings'' if it appears with additional warning statements) if the amount of sodium present in the labeled maximum daily dose of the product is more than 140 milligrams: ``Ask a doctor before use if you have [in bold type] [bullet]\1\ a sodium-restricted diet''. The warnings in Sec. Sec. 201.64(c), 201.70(c), 201.71(c), and 201.72(c) may be combined, if applicable, provided the ingredients are listed in alphabetical order, e g., a calcium or sodium restricted diet. --------------------------------------------------------------------------- \1\ See Sec. 201 .66(b)(4) of this chapter for definition of bullet symbol. --------------------------------------------------------------------------- (d) The term sodium free may be used in the labeling of OTC drug products intended for oral ingestion if the amount of sodium in the labeled maximum daily dose is 5 milligrams or less and the amount of sodium per dosage unit is 0 milligram (when rounded-off in accord with paragraph (b) of this section). * * * * * (j) Any product subject to paragraphs (a) through (h) of this section that is not labeled as required and that is initially introduced or initially delivered for introduction into interstate commerce after the following [[Page 42]] dates is misbranded under sections 201(n) and 502(a) and (f) of the Federal Food, Drug, and Cosmetic Act. (1) As of the date of approval of the application for any single entity and combination products subject to drug marketing applications approved on or after April 23, 2004. (2) Septemeber 24, 2005, for all OTC drug products subject to any OTC drug monograph, not yet the subject of any OTC drug monograph, or subject to drug marketing applications approved before April 23, 2004.