Quantitative Labeling of 
Sodium, Potassium, and 
Phosphorus for Human Over-
the-Counter and Prescription 
Drug Products  
 
Guidance for Industry 
 
 
 
DRAFT GUIDANCE
 
 
  This guidance document is being distributed for comment purposes only. 
 
Comments and suggestions regarding this draft document should be submitted within 60 days of 
publication in the Federal Register of the notice announcing the availability of the draft 
guidance.  Submit electronic comments to https://www.regulations.gov.  Submit written 
comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD  20852.  All comments should be identified with the 
docket number listed in the notice of availability that publishes in the Federal Register. 
 
For questions regarding this draft document, contact (CDER) Dat Doan, 240-402-8926, or 
(CBER) Office of Communication, Outreach and Development, 800-835-4709 or 240-402-8010.  
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
September 2022 
Labeling 
 
8438254dft09-02-22.docx   
Quantitative Labeling of Sodium, 
Potassium, and Phosphorus for 
Human Over-the-Counter and 
Prescription Drug Products  
Guidance for Industry 
 
Additional copies are available from: 
 
Office of Communications, Division of Drug Information  
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD 20993-0002  
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Email: druginfo@fda.hhs.gov  
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and/or 
 
Office of Communication, Outreach and Development  
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 Food and Drug Administration 
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Email: ocod@fda.hhs.gov 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-
guidances 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
 
September 2022 
Labeling 
 
 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  DISCUSSION .................................................................................................................... 2 
III.  LABELING RECOMMENDATIONS............................................................................ 3 
A.  Clarifying What Should Be Quantified in Drug Labeling ......................................................... 3 
B.  Thresholds Below Which FDA Does Not Recommend or Require Quantification in Labeling     
   ......................................................................................................................................................... 3 
C.  Clarifying Quantities Per Dosage Unit......................................................................................... 4 
D.  Rounding ......................................................................................................................................... 4 
E.  OTC and Prescription Drug Product Labeling ........................................................................... 5 
1. OTC Drug Products ......................................................................................................................... 5 
2. Prescription Drug Products ............................................................................................................. 5 
F.  Considerations for Generic Drugs Approved Under Section 505(j) of the Federal Food, 
Drug, and Cosmetic Act ......................................................................................................................... 6 
IV.  SUBMISSION AND ADOPTION RECOMMENDATIONS AND 
REQUIREMENTS ........................................................................................................................ 6 
A.  Drug Products With New or Pending Applications .................................................................... 6 
B.  Drug Products With Approved Applications .............................................................................. 6 
APPENDIX A:  EXAMPLES OF PRESCRIPTION DRUG LABELING .............................. 8 
APPENDIX B:  EXAMPLES OF OTC DRUG LABELING.................................................. 10 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
1  Quantitative Labeling of Sodium, Potassium, and Phosphorus for 
2  Human Over-the-Counter and Prescription Drug Products  
3  Guidance for Industry1 
4   
5   
6  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
7  Administration (FDA or Agency) on this topic.  It does not establish any rights for any person and is not 
8  binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
9  applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
10  for this guidance as listed on the title page.   
11   
12   
13   
14   
15  I.  INTRODUCTION  
16   
17  This guidance provides recommendations for quantitative labeling of sodium, potassium, and 
18  phosphorus present in human prescription and nonprescription (commonly referred to as over-
19  the-counter (OTC)) drugs.2  This guidance addresses sodium, potassium, and phosphorus when 
20  present as constituents of active or inactive drug ingredients3 (e.g., sodium as a constituent of the 
21  inactive ingredient anhydrous trisodium citrate, phosphorus as a constituent of the inactive 
22  ingredient dibasic calcium phosphate, or sodium as a constituent of the active ingredient 
23  naproxen sodium).  Products within the scope of this guidances recommendations are orally 
24  ingested products and injectable medications containing an amount of 5 mg or more of sodium, 
25  potassium, or elemental phosphorus per maximum single dose.  Individuals or entities 
26  responsible for drug product labeling are encouraged to engage with FDA for advice on specific 
27  cases.   
28   
29  This guidance restates the legal requirements set forth in current regulations regarding 
30  quantitative information for sodium and potassium in labeling of OTC products.  (See 21 CFR 
31  201.64 and 201.72.)  It provides additional information to manufacturers who seek to include 
32  quantitative information for sodium, potassium, and phosphorus in labeling for prescription drug 
33  products and for phosphorus in labeling for OTC drugs. 
 
 
1 This guidance has been prepared by the Office of Medical Policy in the Center for Drug Evaluation and Research 
in cooperation with the Center for Biologics Evaluation and Research at the Food and Drug Administration. 
  
2 This guidance applies to drugs, including biological products that are regulated as drugs.  For the purposes of this 
guidance, the terms drug product or drug or product are used to refer to human OTC and prescription drug and 
biological products that are regulated as drugs. 
 
3 As provided for in 21 CFR 201.10(b), The term ingredient applies to any substance in the drug, whether added to 
the formulation as a single substance or in admixture with other substances. 
 
  1  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
34   
35  In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
36  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
37  as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
38  the word should in Agency guidances means that something is suggested or recommended, but 
39  not required. 
40   
41   
42  II.  DISCUSSION  
43   
44  This guidance provides information and recommendations concerning the quantification of 
45  sodium, potassium, and phosphorus in drug product labeling because (1) these substances are 
46  common constituents of ingredients that can be present in drug products in amounts that may 
47  represent a significant portion of an individuals total daily intake and (2) dietary restriction of 
48  these constituents is often recommended for various diseases that affect a substantial number of 
49  patients in the U.S. population. 
50   
51  Sodium, potassium, and phosphorus may be present in drug products as constituents of active or 
52  inactive ingredients.4,5  The amount of these constituents can vary among drug products, 
53  including drugs with the same active ingredient, depending on factors such as the manufacturer, 
54  the formulation, or the dosage form.  For example, the amount of sodium, potassium, or 
55  phosphorus may differ between a reference listed drug6 (RLD) and a generic version of the drug 
56  or between different generic drugs with the same RLD. 
57   
58  Health care providers generally recommend that patients with certain clinical conditionssuch 
59  as heart failure, hypertension, or chronic kidney diseaserestrict dietary intake of sodium, 
60  potassium, and/or phosphorus.  Quantifying these constituents in drug product labeling would 
 
 
 
4 See FDAs database Inactive Ingredient Search for Approved Drugs (available at 
https://www.accessdata.fda.gov/scripts/cder/iig/). 
 
5 See the Orange Book:  Approved Drug Products With Therapeutic Equivalence Evaluations (available at 
https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm) to search for FDA-approved drugs containing sodium, 
potassium, or phosphate as a constituent of an active ingredient. 
 
6 The term reference listed drug is defined in 21 CFR 314.3(b) as the listed drug identified by FDA as the drug 
product upon which an applicant relies in seeking approval of its ANDA [abbreviated new drug application].  The 
term listed drug is defined in 21 CFR 314.3(b) as a new drug product that has been approved under section 505(c) 
of the Federal Food, Drug, and Cosmetic Act for safety and effectiveness or under section 505(j) of the Federal 
Food, Drug, and Cosmetic Act, which has not been withdrawn or suspended under section 505(e)(1) through (5) or 
section (j)(6) of the Federal Food, Drug, and Cosmetic Act, and which has not been withdrawn from sale for what 
FDA has determined are reasons of safety or effectiveness.  Listed drug status is evidenced by a drug products 
identification in the current edition of FDAs publication Approved Drug Products With Therapeutic Equivalence 
Evaluations (commonly referred to as the Orange Book) as an approved drug.  A drug product is deemed to be a 
listed drug on the date of approval for the new drug application (NDA) or ANDA for that drug product. 
 
  2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
61  provide health care providers and patients with information that will help them account for the 
62  amounts of these constituents present in a patients daily drug regimen when determining an 
63  individuals total daily intake.  Quantifying these constituents in drug product labeling as 
64  recommended in this guidance may also allow health care providers and patients to select drug 
65  products with lower amounts of these constituents when such alternatives are available.  
66   
67   
68  III.  LABELING RECOMMENDATIONS  
69   
70  This section provides recommendations on the description and placement of the quantitative 
71  information in labeling for sodium, potassium, and phosphorus. 
72   
73  A.  Clarifying What Should Be Quantified in Drug Labeling 
74   
75  For simplicity and consistency with existing OTC regulations (see section III.E of this guidance), 
76  FDA recommends that drug labeling include certain information about the total amounts of 
77  sodium, potassium, and phosphorus in a drug product, expressed in milligrams (mg).  For sodium 
78  and potassium, this guidance pertains to sodium and potassium ions.  For phosphorus, however, 
79  this guidance pertains to the calculated equivalent amount of elemental phosphorus from all the 
80  phosphorus-containing components.  Although the terms phosphorus (chemical element, P) and 
81  phosphate (PO 3-) are often used interchangeably in the clinical literature, they are not 
4
82  synonymous.  Notably, when expressed in milligrams, phosphate values are approximately three 
83  times the phosphorus values.  Although phosphorus is typically present in nature and in many 
84  drugs as phosphate, expressing drug content in terms of equivalent phosphorous content is in 
85  accordance with dietary intake recommendations and values reported for food and therefore 
86  allows for easier comparisons of quantities of phosphorus in foods and in drugs.    
87   
88  The drug labeling should state the total amount of the constituent, regardless of whether the 
89  constituent is present as part of an active or inactive ingredient.  The amount of sodium, 
90  potassium, or phosphorus in a drug product should be determined from the drug products 
91  formulation information.  For example, if a drug product contains both naproxen sodium and 
92  trisodium citrate, the total amount of sodium in the drug product from both compounds should be 
93  stated.  The amount of sodium present in 1 gram (g) of trisodium citrate, for instance, is 267 mg 
94  as determined stoichiometrically according to its molecular formula (Na C H O ).  Similarly, 1 g 
3 6 5 7
95  of anhydrous dibasic calcium phosphate (CaHPO ) contains 228 mg of phosphorus. 
4
96   
97  B.  Thresholds Below Which FDA Does Not Recommend or Require 
98  Quantification in Labeling  
99   
100  FDA does not recommend or require quantitative information in labeling for sodium, potassium, 
101  or phosphorus if the amount in a maximum single dose of the drug product is less than 5 mg.  
102  The presence of sodium, potassium, and phosphorus in quantities less than 5 mg is not expected 
103  to be clinically significant relative to dietary intake, even in patients taking several 
104  nonprescription and prescription drugs.  For example, if the maximum single dose of a drug 
105  product is two tablets at one time and that total dose contains 4 mg of sodium (2 mg of sodium 
  3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
106  per tablet), FDA does not recommend or require quantitative information in the labeling 
107  regarding the sodium content of the drug product.  In this case, manufacturers may elect to 
108  include a statement in labeling that the product contains less than 5 mg of sodium per tablet.  If 
109  the maximum single dose is two tablets at one time and the total dose contains 8 mg of sodium (4 
110  mg of sodium per tablet), however, FDA would recommend quantitative information in labeling 
111  for sodium content for the drug.  
112   
113  C.  Clarifying Quantities Per Dosage Unit 
114   
115  For consistency across products and for simplicity and ease of determination, FDA recommends 
116  that manufacturers provide quantitative information on a per dosage unit basis.  The dosage unit 
117  should be consistent with the primary expression of potency strength on the container label.  For 
118  oral solids, the amount per tablet, capsule, etc., should be used regardless of how many 
119  tablets/capsules a patient might take at one time or per day as stated in the labeling.  For oral 
120  liquids (or products reconstituted to make an oral liquid), if the strength is expressed as the 
121  amount of drug/mL or amount of drug/5 mL, for the purposes of reporting sodium, potassium, or 
122  phosphorus, the dosage unit will be 1 mL or 5 mL, respectively.   
123    
124  For injectable dosage forms, the dosage unit will be 1 mL, unless the net quantity in the 
125  container is less than 1 mL, in which case the dosage unit will be the net quantity in the 
126  container.    
127   
128  For injectable drug products provided as solids intended to be reconstituted to yield an injectable 
129  solution or suspension, FDA recommends that the quantitative information for sodium, 
130  potassium, and phosphorus be stated as the amount per milliliter (e.g., 5 mg/mL) or per dosage 
131  unit (e.g., 5 mg/0.5 mL) after reconstitution if the labeling provides for the use of a specific 
132  amount of diluent for which the quantitative information for sodium, potassium, or phosphorus is 
133  known.   
134   
135  If you have questions, contact the appropriate FDA review division for guidance. 
136   
137  D.  Rounding 
138   
139  As stated previously, this guidance restates the legal requirements set forth in current regulations 
140  regarding quantitative information in labeling for sodium and potassium for OTC products 
141  intended for oral ingestion.  For simplicity and consistency with existing OTC regulations (see 
142  section III.E of this guidance), FDA recommends (1) that labeling of quantitative information 
143  regarding the total amounts of sodium present in a drug product be stated in milligrams and 
144  rounded to the nearest whole number per dosage unit and (2) that potassium be rounded to the 
145  nearest 5 mg per dosage unit (or expressed in the nearest tenth of a gram if present above 1 g per 
146  dosage unit).  FDA recommends rounding the total amounts of phosphorus present in a drug 
147  product to the nearest 5 mg per dosage unit.  In some cases, doing so will allow for a single 
148  statement in labeling to apply to more than one available strength of a drug product (e.g., Each 
149  tablet contains 20 mg of phosphorus).  See Appendix A for examples. 
150   
  4  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
151  E.  OTC and Prescription Drug Product Labeling  
152   
153  1.  OTC Drug Products 
154   
155  FDA regulations currently require labeling of certain OTC drugs to include quantitative 
156  information for sodium (21 CFR 201.64) and potassium (21 CFR 201.72).  Specifically, the 
157  regulations state that the labeling of OTC drug products intended for oral ingestion must contain 
158  the sodium content per dosage unit (e.g., per tablet, per 5 mL), if the sodium content of a single 
159  maximum recommended dose of the product (which may be one or more dosage units) is 5 mg 
160  or more.  The same standard applies for potassium.  This information is captured under the Other 
161  information heading of the Drug Facts labeling.7 
162   
163  FDAs labeling recommendation in this guidance for phosphorus in OTC drug products aligns 
164  with the existing regulations for sodium and potassium in OTC drug products intended for oral 
165  ingestion.8  For orally ingested OTC drugs, FDA recommends (1) including the amount of 
166  phosphorus in the Drug Facts labeling under the heading Other information and (2) labeling the 
167  phosphorus content per dosage unit (e.g., per tablet) if the phosphorus content of a single 
168  maximum recommended dose of the product (which may be one or more dosage units) is 5 mg 
169  or more.  See Appendix B for examples regarding this section. 
170   
171  2.  Prescription Drug Products 
172   
173  When quantitative information on sodium, potassium, and phosphorus content is included in 
174  prescription drug labeling, it should be presented per dosage unit in the DESCRIPTION section 
175  of labeling, following the list of inactive ingredients.  See Appendix A for examples regarding 
176  this section. 
177   
178  We note that for some biological products, such as cellular therapy products, quantification may 
179  be difficult.  In such cases, we recommend that manufacturers considering including information 
180  about these substances discuss with the appropriate FDA review division how to quantify these 
181  substances.    
182   
 
 
7 See 21 CFR 201.64 and 201.72, respectively.  See also 21 CFR 201.66(c)(7)(i). 
 
8 See 21 CFR 201.64 (sodium), 201.72 (potassium), and 331.11 (listing of specific active ingredients).  FDA has 
also issued the guidance for industry Labeling OTC Human Drug Products  Questions and Answers (December 
2008).  We update guidances periodically.  To ensure that you have the most recent version of a guidance, check 
FDAs guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.   
 
  5  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
183  F.  Considerations for Generic Drugs Approved Under Section 505(j) of the 
184  Federal Food, Drug, and Cosmetic Act 
185   
186  Generally, drug product labeling for a drug approved under an abbreviated new drug application 
187  (ANDA) is required to be the same as the labeling for the RLD, with certain permissible labeling 
188  differences because the ANDA and the RLD are produced or distributed by different 
189  manufacturers.  Permissible differences include, for example, differences in labeling made to 
190  comply with current FDA labeling guidelines or other guidance (see section 505(j)(2)(A)(v) of 
191  the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355)) and 21 CFR 
192  314.94(a)(8)(iv)).   
193   
194  An ANDA or a supplement to an ANDA that proposes to include quantitative information in its 
195  proposed labeling for sodium, potassium, and/or phosphorus, as recommended in this guidance, 
196  or proposes to omit such quantitative information, even if the inclusion or omission of such 
197  information differs from how such information is reflected in the labeling for the RLD, may be 
198  acceptable, provided the requirements for approval are met.   
199   
200   
201  IV.  SUBMISSION AND ADOPTION RECOMMENDATIONS AND 
202  REQUIREMENTS 
203   
204  This section describes recommendations and requirements for manufacturers on how to submit 
205  labeling that includes quantitative information about sodium, potassium, and/or phosphorus for a 
206  drug product.  
207   
208  A.  Drug Products With New or Pending Applications 
209   
210  An applicant submitting a new drug application (NDA), an ANDA, or a biologics license 
211  application (BLA) that elects to include quantitative information on sodium, potassium, or 
212  phosphorus in product labeling must ensure that the labeling statement is accurate and is 
213  supported by information related to the drug products ingredients.9  Support for the quantitative 
214  information regarding the amounts of constituents of ingredients that are described in labeling 
215  should be submitted in the chemistry, manufacturing, and controls section of the application, 
216  under the heading DESCRIPTION AND COMPOSITION OF THE DRUG PRODUCT.  
217  Manufacturers with pending applications may add this information when they propose changes 
218  to their draft labeling during the application review process.    
219   
220  B.  Drug Products With Approved Applications 
221   
222  If a drug products labeling already includes information on the constituents discussed in this 
223  guidance, manufacturers should review this guidance and determine whether they should revise 
224  their labeling to meet the current content and format recommendations. 
225   
 
 
9 See section 502(a) of the FD&C Act (21 U.S.C. 352(a)). 
  6  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
226  When an NDA, ANDA, or BLA holder plans to add or revise quantitative information about 
227  sodium, potassium, and phosphorus in drug product labeling without changes to the approved 
228  product formulationand the change is not combined with another change that requires 
229  submission of a supplementthe application holder may revise labeling at any time.  Pursuant to 
230  21 CFR 314.70(a)(3) and 21 CFR 601.12(a)(3), FDA recommends that application holders 
231  provide notification and supporting information in an annual report when drug product labeling 
232  is changed to include the quantities of sodium, potassium, and/or phosphorus without other 
233  changes to the product or its labeling that would require submission of a supplement. 
234   
235   
  7  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
236  APPENDIX A:  EXAMPLES OF PRESCRIPTION DRUG LABELING 
237   
238  This appendix provides examples of quantitative labeling statements for prescription drugs 
239  containing sodium, potassium, and phosphorus as constituents of prescription drug ingredients in 
240  products with single or multiple strengths and for products with different dosage forms.1  The 
241  Food and Drug Administration (FDA) recommends that these constituents be listed in 
242  alphabetical order when more than one is quantified in labeling. 
243   
244  1.  For prescription drug products available in a single strength, state the amount of each 
245  constituent present in the product.  For example: 
246   
247  Each [insert DRUG name] tablet contains 5 mg of potassium and 9 mg of sodium. 
248   
249  Each [insert DRUG name] tablet contains 7 mg of sodium. 
250   
251  2.  For prescription drug products available in multiple strengths containing multiple 
252  constituents, these data may be presented in a concise and readable manner (e.g., in a 
253  table).  For example: 
254   
Table 1. Phosphorus, Potassium, and Sodium Constituents for [insert 
DRUG name] 
 
Tablet Strength  Phosphorus  Potassium  Sodium  
Per Dosage Unit   Content  Content  Content 
50 mg tablet  20 mg  10 mg  43 mg 
100 mg tablet  40 mg  35 mg  50 mg 
150 mg tablet  60 mg  50 mg  62 mg 
255   
256  3.  For prescription drug products available in multiple strengths with similar constituent 
257  content, the information may be more efficiently presented in a sentence or two rather 
258  than a table.  For example: 
259   
260  All strengths of [insert DRUG name] tablets contain less than 5 mg each of 
261  phosphorus and potassium per tablet.  The 5 mg and 15 mg [insert DRUG name] 
262  tablets each contain 7 mg of sodium.  The 30 mg tablet contains 12 mg of sodium.  
263   
264  The 5 mg and 15 mg [insert DRUG name] tablets each contain 5 mg of phosphorus.  
265  The 30 mg tablet contains 10 mg of phosphorus. 
266   
267  The 5 mg and 15 mg [insert DRUG name] tablets each contain 5 mg of potassium 
268  and sodium.  The 30 mg tablet contains 10 mg each of potassium and sodium. 
269   
 
 
1 The examples in this appendix are for illustrative purposes only and should not be considered exhaustive.  
Alternative wording can be proposed for FDAs consideration, as appropriate. 
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Draft  Not for Implementation 
 
270  4.  For drug products supplied as solutions or suspensions for injection, FDA recommends 
271  that quantitative information for sodium, potassium, and phosphorus be stated as the 
272  amount per milliliter (e.g., 10 mg/mL).  For example: 
273   
274  Each 1 mL of [insert DRUG name] injection contains 33 mg of sodium and less than 
275  5 mg each of phosphorus and potassium. 
276   
277  Alternatively, for oral drug products supplied as solutions or suspensions or as solids 
278  intended to be reconstituted to yield oral solutions or suspensions, FDA recommends that 
279  quantitative information for sodium, potassium, and phosphorus be stated for the most 
280  commonly administered dosage unit of volume.  For example: 
281   
282  Each 5 mL of [insert DRUG name] oral solution contains 100 mg of potassium, 
283  47 mg of sodium, and less than 5 mg of phosphorus. 
284   
285  5.  For drug products containing less than 5 mg of sodium, potassium, or phosphorus in the 
286  maximum recommended single dose, applicants may include this information in labeling.  
287  For example: 
288   
289  Each [insert DRUG name] capsule contains less than 5 mg each of sodium, 
290  potassium, and phosphorus. 
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291  APPENDIX B:  EXAMPLES OF OTC DRUG LABELING 
292   
293  This appendix provides examples of statements to include in the labeling of nonprescription 
294  (commonly referred to as over-the-counter (OTC)) drug products containing sodium, potassium, 
295  and phosphorus as constituents of the products ingredients.1   
296   
297  If manufacturers choose to include the recommended phosphorus content within the Drug Facts 
298  labeling, it should be included in alphabetical order within the required list of constituents under 
299  the heading Other information.  Although a statement of phosphorus content would be 
300  considered additional information,2 phosphorus should be included in alphabetical order within 
301  the list of required constituents, to avoid confusion. 
302   
303  If applicable, the first bulleted statement under this heading must include calcium (21 CFR 
304  201.70), magnesium (21 CFR 201.71), potassium (21 CFR 201.72), and sodium (21 CFR 
305  201.64) to read as follows:   
306   
307  [in bold type] Each (insert appropriate dosage unit) contains: [in non-bold type, insert 
308  name(s) of ingredient(s) and quantity of each ingredient].   
309   
310  Example 1:  Labeling statement when maximum single dose (which may be one or more 
311  dosage units) contains 5 mg or more of constituent (i.e., sodium, potassium, and 
312  phosphorus):  
313   
314  Other information  
315   
316  Each tablet contains: calcium 20 mg, magnesium 10 mg, phosphorus 5 mg, potassium 
317  5 mg, and sodium 13 mg  
318   
319  [bullet]  Phenylketonurics:  Contains phenylalanine 10 mg per tablet  
320   
321  [bullet]  [insert storage conditions]  
322   
323  [bullet]  [insert tamper-evident statement] 
324   
325   
326   
327   
 
 
 
1 The examples in this appendix are for illustrative purposes only and should not be considered exhaustive.  
Alternative wording can be proposed for FDAs consideration, as appropriate. 
 
2 See also 21 CFR 201.66(c)(7). 
 
  10  Contains Nonbinding Recommendations 
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328  Example 2:  Labeling statement when maximum single dose contains less than 5 mg of 
329  constituent (i.e., sodium, potassium, and phosphorus): 
330   
331  If firms choose to include the statement for phosphorus, potassium, and sodium in the Drug Facts 
332  labeling when the maximum single dose contains less than 5 mg of constituent (i.e., sodium, 
333  potassium, and phosphorus), this information should appear as the last statement under the 
334  subheading Other information.   Placement of such statements should not interfere with the 
335  required information in the labeling. 
336   
337  Other information  
338   
339  [bullet]  Phenylketonurics:  Contains phenylalanine 10 mg per tablet  
340   
341  [bullet]  [insert storage conditions]  
342   
343  [bullet]  [insert tamper-evident statement] 
344   
345  [bullet]  [insert relevant constituent; for example, contains less than 5 mg sodium per 
346  tablet] 
347   
348    
349   
350   
  11