{"database": "openregs", "table": "cfr_sections", "is_view": false, "human_description_en": "where agency = \"FDA\" and part_number = 335 sorted by section_id", "rows": [["21:21:5.0.1.1.15.1.1.1", 21, "Food and Drugs", "I", "D", "335", "PART 335\u2014ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "A", "Subpart A\u2014General Provisions", "", "\u00a7 335.1 Scope.", "FDA", "", "", "", "(a) An over-the-counter antidiarrheal drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in \u00a7 330.1 of this chapter.\n\n(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted."], ["21:21:5.0.1.1.15.1.1.2", 21, "Food and Drugs", "I", "D", "335", "PART 335\u2014ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "A", "Subpart A\u2014General Provisions", "", "\u00a7 335.3 Definitions.", "FDA", "", "", "[68 FR 18881, Apr. 17, 2003, as amended at 69 FR 26302, May 12, 2004]", "As used in this part:\n\n(a)  Antidiarrheal.  A drug that can be shown by objective measurement to treat or control (stop) the symptoms of diarrhea.\n\n(b)  Diarrhea.  A condition characterized by increased frequency of loose, watery stools (three or more daily) during a limited period (24 to 48 hours), usually with no identifiable cause.\n\n(c)  Travelers' diarrhea.  A subset of diarrhea occurring in travelers that is most commonly caused by an infectious agent."], ["21:21:5.0.1.1.15.2.1.1", 21, "Food and Drugs", "I", "D", "335", "PART 335\u2014ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "B", "Subpart B\u2014Active Ingredients", "", "\u00a7 335.10 Antidiarrheal active ingredients.", "FDA", "", "", "", "The active ingredient of the product consists of any one of the following when used within the dosage limits established for each ingredient in \u00a7 335.50(d):\n\n(a) Bismuth subsalicylate.\n\n(b) Kaolin."], ["21:21:5.0.1.1.15.3.1.1", 21, "Food and Drugs", "I", "D", "335", "PART 335\u2014ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "C", "Subpart C\u2014Labeling", "", "\u00a7 335.50 Labeling of antidiarrheal drug products.", "FDA", "", "", "[68 FR 18881, Apr. 17, 2003, as amended at 69 FR 26302, May 12, 2004]", "(a)  Statement of identity.  The labeling of the product contains the established name of the drug, if any, and identifies the product either as an \u201cantidiarrheal\u201d or \u201cfor diarrhea.\u201d\n\n(b)  Indications.  The labeling of the product states, under the heading \u201cUse,\u201d one or more of the phrases listed in this paragraph (b), as appropriate. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b) may also be used, as provided in \u00a7 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.\n\n(1)  For products containing bismuth subsalicylate identified in \u00a7 335.10(a).  The labeling states [select one of the following: \u201ccontrols\u201d or \u201crelieves\u201d] [select one or both of the following: \u201cdiarrhea\u201d or \u201ctravelers' diarrhea\u201d]. If both \u201cdiarrhea\u201d and \u201ctravelers' diarrhea\u201d are selected, each shall be preceded by a bullet in accordance with \u00a7 201.66(b)(4) and (d)(4) of this chapter and the heading \u201cUses\u201d shall be used.\n\n(2)  For products containing kaolin identified in \u00a7 335.10(b).  The labeling states \u201chelps firm stool within 24 to 48 hours\u201d.\n\n(3)  Additional indications \u2014(i) When any additional indications are used, the heading \u201cUses\u201d shall be used and each listed use shall be preceded by a bullet in accord with \u00a7 201.66(b)(4) of this chapter.\n\n(ii) In addition to the indication in paragraph (b)(1) of this section, one or both of the following may be used for products containing bismuth subsalicylate in \u00a7 335.10(a): \u201c[bullet] reduces number of bowel movements\u201d \u201c[bullet] helps firm stool\u201d.\n\n(c)  Warnings.  The labeling of the product contains the following warnings under the heading \u201cWarnings\u201d:\n\n(1)  For products containing any ingredient identified in \u00a7 335.10.  (i) \u201cDo not use if you have [bullet] bloody or black stool\u201d.\n\n(ii) \u201cAsk a doctor before use if you have [bullet] fever [bullet] mucus in the stool\u201d.\n\n(2)  For products containing bismuth subsalicylate identified in \u00a7 335.10(a).  (i) The following shall appear in accordance with \u00a7 201.66(c)(5)(ii) of this chapter.\n\n(A) The Reye's syndrome warning in \u00a7 201.314(h) of this chapter.\n\n(B) \u201cAllergy alert: Contains salicylate. Do not take if you are [bullet] allergic to salicylates (including aspirin), [bullet] taking other salicylate products\u201d.\n\n(ii) \u201cDo not use if you have [bullet] an ulcer [bullet] a bleeding problem\u201d.\n\n(iii) \u201cAsk a doctor or pharmacist before use if you are taking any drug for [bullet] anticoagulation (thinning the blood) [bullet] diabetes [bullet] gout [bullet] arthritis\u201d.\n\n(iv) \u201cWhen using this product a temporary, but harmless, darkening of the stool and/or tongue may occur\u201d.\n\n(v) \u201cStop use and ask a doctor if [bullet] symptoms get worse [bullet] ringing in the ears or loss of hearing occurs [bullet] diarrhea lasts more than 2 days\u201d.\n\n(3)  For products containing kaolin identified in \u00a7 335.10(b).  (i) \u201cAsk a doctor or pharmacist before use if you are taking any other drugs. Try to use at least 3 hours before or after taking any other drugs.\u201d\n\n(ii) \u201cStop use and ask a doctor if [bullet] symptoms get worse [bullet] diarrhea lasts more than 2 days\u201d.\n\n(d)  Directions.  The labeling of the product contains the following information under the heading \u201cDirections\u201d:\n\n(1)  For products containing any ingredient identified in \u00a7 335.10.  The labeling states \u201c[bullet] drink plenty of clear fluids to help prevent dehydration caused by diarrhea\u201d.\n\n(2)  For products containing bismuth subsalicylate identified in \u00a7 335.10(a).  The labeling states \u201c[bullet] adults and children 12 years and over:\u201d 525 milligrams \u201cevery \n 1/2  to 1 hour, or\u201d 1,050 milligrams \u201cevery hour as needed [bullet] do not exceed\u201d 4,200 milligrams \u201cin 24 hours [bullet] use until diarrhea stops but not more than 2 days [bullet] children under 12 years: ask a doctor\u201d.\n\n(3)  For products containing kaolin identified in \u00a7 335.10(b).  The labeling states \u201c[bullet] adults and children 12 years and over:\u201d 26.2 grams \u201cafter each loose stool [bullet] continue to take every 6 hours until stool is firm but not more than 2 days [bullet] do not exceed\u201d [262 grams] \u201cin 24 hours [bullet] children under 12 years of age: ask a doctor\u201d.\n\n(e)  Products that meet the criteria established in \u00a7 201.66(d)(10) of this chapter.  The information described in \u00a7 201.66(c) of this chapter shall be printed in accordance with the following specifications.\n\n(1) The labeling shall meet the requirements of \u00a7 201.66(c) of this chapter except that the information in \u00a7 201.66(c)(3) of this chapter may be omitted, and the information in \u00a7 201.66(c)(5) and (c)(6) of this chapter may be presented as follows:\n\n(i) The words \u201cContains salicylate.\u201d may be omitted from the warning in \u00a7 335.50(c)(2)(i)(B).\n\n(ii) The subheading \u201cWhen using this product\u201d in \u00a7 335.50(c)(2)(iv) may be omitted.\n\n(iii) The words \u201ccontinue to\u201d may be omitted from the directions in \u00a7 335.50(d)(3).\n\n(2) The labeling shall be printed in accordance with the requirements of \u00a7 201.66(d) of this chapter except that any requirements related to \u00a7 201.66(c)(3) of this chapter and the bullet in the warning in \u00a7 335.50(c)(1)(i) may be omitted."]], "truncated": false, "filtered_table_rows_count": 4, "expanded_columns": [], "expandable_columns": [], "columns": ["section_id", "title_number", "title_name", "chapter", "subchapter", "part_number", "part_name", "subpart", "subpart_name", "section_number", "section_heading", "agency", "authority", "source_citation", "amendment_citations", "full_text"], "primary_keys": ["section_id"], "units": {}, "query": {"sql": "select section_id, title_number, title_name, chapter, subchapter, part_number, part_name, subpart, subpart_name, section_number, section_heading, agency, authority, source_citation, amendment_citations, full_text from cfr_sections where \"agency\" = :p0 and \"part_number\" = :p1 order by section_id limit 101", "params": {"p0": "FDA", "p1": "335"}}, "facet_results": {"title_number": {"name": "title_number", "type": "column", "hideable": false, "toggle_url": "/openregs/cfr_sections.json?agency=FDA&part_number=335", "results": [{"value": 21, "label": 21, "count": 4, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?agency=FDA&part_number=335&title_number=21", "selected": false}], "truncated": false}, "agency": {"name": "agency", "type": "column", "hideable": false, "toggle_url": "/openregs/cfr_sections.json?agency=FDA&part_number=335", "results": [{"value": "FDA", "label": "FDA", "count": 4, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=335", "selected": true}], "truncated": false}, "part_number": {"name": "part_number", "type": "column", "hideable": false, "toggle_url": "/openregs/cfr_sections.json?agency=FDA&part_number=335", "results": [{"value": "335", "label": "335", "count": 4, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?agency=FDA", "selected": true}], "truncated": false}}, "suggested_facets": [{"name": "subpart", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?agency=FDA&part_number=335&_facet=subpart"}, {"name": "subpart_name", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?agency=FDA&part_number=335&_facet=subpart_name"}, {"name": "amendment_citations", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?agency=FDA&part_number=335&_facet=amendment_citations"}], "next": null, "next_url": null, "private": false, "allow_execute_sql": true, "query_ms": 393.46910011954606, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}