{"database": "openregs", "table": "cfr_sections", "is_view": false, "human_description_en": "where part_number = 332 and title_number = 21 sorted by section_id", "rows": [["21:21:5.0.1.1.13.1.1.1", 21, "Food and Drugs", "I", "D", "332", "PART 332\u2014ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "A", "Subpart A\u2014General Provisions", "", "\u00a7 332.1 Scope.", "FDA", "", "", "", "An over-the-counter antiflatulent product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each of the following conditions and each of the general conditions established in \u00a7 330.1 of this chapter."], ["21:21:5.0.1.1.13.1.1.2", 21, "Food and Drugs", "I", "D", "332", "PART 332\u2014ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "A", "Subpart A\u2014General Provisions", "", "\u00a7 332.3 Definitions.", "FDA", "", "", "[61 FR 8838, Mar. 5, 1996]", "As used in this part:\n\nAntigas.  A term that may be used interchangeably with the term antiflatulent. Neither term should be considered as describing the mechanism of action of the active ingredient contained in the product."], ["21:21:5.0.1.1.13.2.1.1", 21, "Food and Drugs", "I", "D", "332", "PART 332\u2014ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "B", "Subpart B\u2014Active Ingredients", "", "\u00a7 332.10 Antiflatulent active ingredients.", "FDA", "", "", "", "Simethicone; maximum daily dose 500 mg. There is no dosage limitation at this time for professional labeling."], ["21:21:5.0.1.1.13.2.1.2", 21, "Food and Drugs", "I", "D", "332", "PART 332\u2014ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "B", "Subpart B\u2014Active Ingredients", "", "\u00a7 332.15 Combination with non-antiflatulent active ingredients.", "FDA", "", "", "", "An antiflatulent may contain any generally recognized as safe and effective antacid ingredient(s) if it is indicated for use solely for the concurrent symptoms of gas associated with heartburn, sour stomach or acid indigestion."], ["21:21:5.0.1.1.13.3.1.1", 21, "Food and Drugs", "I", "D", "332", "PART 332\u2014ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "C", "Subpart C\u2014Labeling", "", "\u00a7 332.30 Labeling of antiflatulent drug products.", "FDA", "", "", "[39 FR 19877, June 4, 1974, as amended at 40 FR 11719, Mar. 13, 1975; 51 FR 16266, May 1, 1986; 51 FR 27763, Aug. 1, 1986; 52 FR 7830, Mar. 13, 1987; 61 FR 8838, Mar. 5, 1996]", "(a)  Statement of identity.  The labeling of the product contains the established name of the drug, if any, and identifies the product as an \u201cantiflatulent,\u201d \u201cantigas,\u201d or \u201cantiflatulent (antigas).\u201d\n\n(b)  Indications.  The labeling of the product states, under the heading \u201cIndications,\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) (Select one of the following: \u201cAlleviates or Relieves\u201d) \u201cthe symptoms referred to as gas.\u201d\n\n(2) (Select one of the following: \u201cAlleviates\u201d or \u201cRelieves\u201d) (select one or more of the following: \u201cbloating,\u201d \u201cpressure,\u201d \u201cfullness,\u201d or \u201cstuffed feeling\u201d) \u201ccommonly referred to as gas.\u201d\n\n(c)  Exemption from the general accidental overdose warning.  The labeling for antiflatulent drug products containing simethicone identified in \u00a7 332.10 and antacid/antiflatulent combination drug products provided for in \u00a7 332.15, containing the active ingredients identified in \u00a7 331.11(a), (b), and (d) through (m) of this chapter are exempt from the requirement in \u00a7 330.1(g) of this chapter that the labeling bear the general warning statement \u201cIn case of accidental overdose, seek professional assistance or contact a poison control center immediately.\u201d The labeling must continue to bear the first part of the general warning in \u00a7 330.1(g) of this chapter, which states, \u201cKeep this and all drugs out of the reach of children.\u201d"], ["21:21:5.0.1.1.13.3.1.2", 21, "Food and Drugs", "I", "D", "332", "PART 332\u2014ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE", "C", "Subpart C\u2014Labeling", "", "\u00a7 332.31 Professional labeling.", "FDA", "", "", "", "(a) The labeling of the product provided to health professionals (but not to the general public) may contain as additional indications postoperative gas pain or for use in endoscopic examination.\n\n(b) Professional labeling for an antiflatulent-antacid combination may contain information allowed for health professionals for antacids and antiflatulents."]], "truncated": false, "filtered_table_rows_count": 6, "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 \"part_number\" = :p0 and \"title_number\" = :p1 order by section_id limit 101", "params": {"p0": "332", "p1": "21"}}, "facet_results": {"title_number": {"name": "title_number", "type": "column", "hideable": false, "toggle_url": "/openregs/cfr_sections.json?part_number=332&title_number=21", "results": [{"value": 21, "label": 21, "count": 6, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=332", "selected": true}], "truncated": false}, "agency": {"name": "agency", "type": "column", "hideable": false, "toggle_url": "/openregs/cfr_sections.json?part_number=332&title_number=21", "results": [{"value": "FDA", "label": "FDA", "count": 6, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=332&title_number=21&agency=FDA", "selected": false}], "truncated": false}, "part_number": {"name": "part_number", "type": "column", "hideable": false, "toggle_url": "/openregs/cfr_sections.json?part_number=332&title_number=21", "results": [{"value": "332", "label": "332", "count": 6, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?title_number=21", "selected": true}], "truncated": false}}, "suggested_facets": [{"name": "subpart", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=332&title_number=21&_facet=subpart"}, {"name": "subpart_name", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=332&title_number=21&_facet=subpart_name"}, {"name": "amendment_citations", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=332&title_number=21&_facet=amendment_citations"}], "next": null, "next_url": null, "private": false, "allow_execute_sql": true, "query_ms": 239.36632508412004, "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"}