{"id":310,"date":"2026-02-18T20:58:19","date_gmt":"2026-02-18T20:58:19","guid":{"rendered":"https:\/\/www.libertymanagement.us\/fda-news\/?p=310"},"modified":"2026-02-18T20:58:19","modified_gmt":"2026-02-18T20:58:19","slug":"antacids-fda-regulation","status":"publish","type":"post","link":"https:\/\/www.libertymanagement.us\/fda-news\/2026\/02\/18\/antacids-fda-regulation\/","title":{"rendered":"ANTACIDS FDA REGULATION"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.fdahelp.us\/fda_otc\/antacid.html\">Antacids<\/a>\nare <a href=\"https:\/\/www.fdahelp.us\/otc-drug-products.html\">over the counter\n(OTC) drugs<\/a> that helps with indigestion and heartburn by neutralizing\nstomach acids. Usually, antacids come in chewable tablets or liquid can be purchased\nfrom pharmacies without any prescription.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The active ingredients used in antacids vary depending on\nthe type of brand. The most common ingredients are as below.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Alginate.<\/li><li>Aluminum hydroxide.<\/li><li>Calcium carbonate.<\/li><li>Magnesium carbonate.<\/li><li>Magnesium hydroxide.<\/li><li>Magnesium  trisilicate.<\/li><li>Sodium bicarbonate.<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">To market Antacids in the US, below are process the company must\ncomply with.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Drug establishment registration <\/li><li>Product listing <\/li><li>Label compliance<\/li><li>cGMP regulations<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>1. Drug Establishment Registration<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Every domestic or foreign establishment that manufactures,\nrepacks, or relabels drug products (including antacids) for the U.S. market\nmust register with the&nbsp;<a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noreferrer noopener\">FDA<\/a>.&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Timing:<\/strong>&nbsp;New\n     facilities must register within&nbsp;<strong>5 days<\/strong>&nbsp;of beginning\n     operations.<\/li><li><strong>Renewal:<\/strong>&nbsp;Registration\n     must be renewed annually between&nbsp;<strong>October 1 and December 31<\/strong>.<\/li><li><strong>Verification:<\/strong>&nbsp;Registration\n     can be verified at &nbsp;<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cder\/drls\/\">https:\/\/www.accessdata.fda.gov\/scripts\/cder\/drls\/<\/a>\n     <\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2. Product Listing<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Registered facilities are required to list all\ndrug products they market. Each product is assigned to a unique&nbsp;<a href=\"https:\/\/www.fdahelp.us\/fda-labeler-code.html\"><strong>National Drug Code (NDC)<\/strong>.&nbsp;<\/a><\/li><li><strong>Compliance:<\/strong>&nbsp;Most\n     antacids marketed under&nbsp;<strong>OTC Monograph M001.11<\/strong>, which sets\n     standard rules for safety.<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3. Label compliance<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Labels must include \u201cDrug facts\u2019 with\nindications, warnings, direction of use and contact information to report\nadverse events.<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"http:\/\/www.fdahelp.us\">Liberty Management Group<\/a> , as a leading FDA consultant will provide assistance \u00a0with drug <a href=\"https:\/\/www.fdahelp.us\/fda-drug-registration.html\">establishment registration<\/a>, drug listing and <a href=\"https:\/\/www.fdahelp.us\/fda-label-review.html#1review\">label review.<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sudha S<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Regulatory Consultant<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Email : office@libertymanagement.us<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"http:\/\/www.fdahelp.us\">www.fdahelp.us<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Antacids are over the counter (OTC) drugs that helps with indigestion and heartburn by neutralizing stomach acids. Usually, antacids come in chewable tablets or liquid can be purchased from pharmacies without any prescription. The active ingredients used in antacids vary depending on the type of brand. The most common ingredients are as below. Alginate. Aluminum &hellip; <a href=\"https:\/\/www.libertymanagement.us\/fda-news\/2026\/02\/18\/antacids-fda-regulation\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;ANTACIDS FDA REGULATION&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[26],"tags":[6,37,42],"class_list":["post-310","post","type-post","status-publish","format-standard","hentry","category-fda-registration-drug","tag-fda-drug-labeling","tag-fda-drug-listing-renewal","tag-fda-drug-registration"],"_links":{"self":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/310","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/comments?post=310"}],"version-history":[{"count":1,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/310\/revisions"}],"predecessor-version":[{"id":311,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/310\/revisions\/311"}],"wp:attachment":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/media?parent=310"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/categories?post=310"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/tags?post=310"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}