FDA label 75eebf07-eadb-4b8d-b67c-a5a5780dcfdf

2.2 Dosage for Hepatic Encephalopathy The recommended dose of XIFAXAN is one 550 mg tablet taken orally two times a day, with or without food [see Clinical Pharmacology ( 12.3 )].

5 WARNINGS AND PRECAUTIONS Travelers’ Diarrhea Not Caused by E. coli : XIFAXAN was not effective in diarrhea complicated by fever and/or blood in the stool or diarrhea due to pathogens other than E. coli . If diarrhea symptoms get worse or persist for more than 24-48 hours, discontinue XIFAXAN and consider alternative antibiotics ( 5.1 ) Clostridium difficile -Associated Diarrhea: Evaluate if diarrhea occurs after therapy or does not improve or worsens during therapy ( 5.2 ) Hepatic Impairment: Use with caution in patients with severe (Child-Pugh C) hepatic impairment ( 5.4 , 8.7 ) 5.1 Travelers’ Diarrhea Not Caused by Escherichia coli XIFAXAN was not found to be effective in patients with diarrhea complicated by fever and/or blood in the stool or diarrhea due to pathogens other than Escherichia coli . Discontinue XIFAXAN if diarrhea symptoms get worse or persist more than 24-48 hours and alternative antibiotic therapy should be considered. XIFAXAN is not effective in cases of travelers’ diarrhea due to Campylobacter jejuni . The effectiveness of XIFAXAN in travelers’ diarrhea caused by Shigella spp. and Salmonella spp. has not been proven. XIFAXAN should not be used in patients where Campylobacter jejuni , Shigella spp., or Salmonella spp. may be suspected as causative pathogens. 5.2 Clostridium difficile -Associated Diarrhea Clostridium difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon which may lead to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. 5.3 Development of Drug Resistant Bacteria Prescribing XIFAXAN for travelers’ diarrhea in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. 5.4 Severe (Child-Pugh C) Hepatic Impairment There is increased systemic exposure in patients with severe hepatic impairment. Animal toxicity studies did not achieve systemic exposures that were seen in patients with severe hepatic impairment. The clinical trials were limited to patients with MELD scores <25. Therefore, caution should be exercised when administering XIFAXAN to patients with severe hepatic impairment (Child-Pugh C) [see Use in Specific Populations ( 8.7 ), Nonclinical Toxicology ( 13.2 ) and Clinical Studies ( 14.2 )] .

5.1 Travelers’ Diarrhea Not Caused by Escherichia coli XIFAXAN was not found to be effective in patients with diarrhea complicated by fever and/or blood in the stool or diarrhea due to pathogens other than Escherichia coli . Discontinue XIFAXAN if diarrhea symptoms get worse or persist more than 24-48 hours and alternative antibiotic therapy should be considered. XIFAXAN is not effective in cases of travelers’ diarrhea due to Campylobacter jejuni . The effectiveness of XIFAXAN in travelers’ diarrhea caused by Shigella spp. and Salmonella spp. has not been proven. XIFAXAN should not be used in patients where Campylobacter jejuni , Shigella spp., or Salmonella spp. may be suspected as causative pathogens.

5.2 Clostridium difficile -Associated Diarrhea Clostridium difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon which may lead to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

6 ADVERSE REACTIONS Most common adverse reactions in travelers’ diarrhea (≥ 5%): Flatulence, headache, abdominal pain, rectal tenesmus, defecation urgency and nausea ( 6.1 ) Most common adverse reactions in HE (≥ 10%): Peripheral edema, nausea, dizziness, fatigue, ascites, flatulence, and headache ( 6.1 ) To report suspected adverse reactions, contact Salix Pharmaceuticals at 1-800-508-0024 and www.Salix.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Travelers’ Diarrhea The safety of XIFAXAN 200 mg taken three times a day was evaluated in patients with travelers’ diarrhea consisting of 320 patients in two placebo-controlled clinical trials with 95% of patients receiving three or four days of treatment with XIFAXAN. The population studied had a mean age of 31.3 (18-79) years of which approximately 3% were ≥ 65 years old, 53% were male and 84% were White, 11% were Hispanic. Discontinuations due to adverse reactions occurred in 0.4% of patients. The adverse reactions leading to discontinuation were taste loss, dysentery, weight decrease, anorexia, nausea and nasal passage irritation. All adverse reactions for XIFAXAN 200 mg three times daily that occurred at a frequency ≥ 2% in the two placebo-controlled trials combined are provided in Table 1. (These include adverse reactions that may be attributable to the underlying disease.) Table 1. All Adverse Reactions With an Incidence ≥2% Among Patients Receiving XIFAXAN Tablets, 200 mg Three Times Daily, in Placebo-Controlled Studies MedDRA Preferred Term Number (%) of Patients XIFAXAN Tablets, 600 mg/day (N = 320) Placebo N = 228 *NOS: Not otherwise specified Flatulence 36 (11%) 45 (20%) Headache 31 (10%) 21 (9%) Abdominal Pain NOS * 23 (7%) 23 (10%) Rectal Tenesmus 23 (7%) 20 (9%) Defecation Urgency 19 (6%) 21 (9%) Nausea 17 (5%) 19 (8%) Constipation 12 (4%) 8 (4%) Pyrexia 10 (3%) 10 (4%) Vomiting NOS 7 (2%) 4 (2%) The following adverse reactions, presented by body system, have also been reported in <2% of patients taking XIFAXAN in the two placebo-controlled clinical trials where the 200 mg tablet was taken three times a day for travelers’ diarrhea. The following includes adverse reactions regardless of causal relationship to drug exposure. Blood and Lymphatic System Disorders: Lymphocytosis, monocytosis, neutropenia Ear and Labyrinth Disorders: Ear pain, motion sickness, tinnitus Gastrointestinal Disorders: Abdominal distension, diarrhea NOS, dry throat, fecal abnormality NOS, gingival disorder NOS, inguinal hernia NOS, dry lips, stomach discomfort General Disorders and Administration Site Conditions: Chest pain, fatigue, malaise, pain NOS, weakness Infections and Infestations: Dysentery NOS, respiratory tract infection NOS, upper respiratory tract infection NOS Injury and Poisoning: Sunburn Investigations: Aspartate aminotransferase increased, blood in stool, blood in urine, weight decreased Metabolic and Nutritional Disorders: Anorexia, dehydration Musculoskeletal, Connective Tissue, and Bone Disorders: Arthralgia, muscle spasms, myalgia, neck pain Nervous System Disorders: Abnormal dreams, dizziness, migraine NOS, syncope, loss of taste Psychiatric Disorders: Insomnia Renal and Urinary Disorders: Choluria, dysuria, hematuria, polyuria, proteinuria, urinary frequency Respiratory, Thoracic, and Mediastinal Disorders: Dyspnea NOS, nasal passage irritation, nasopharyngitis, pharyngitis, pharyngolaryngeal pain, rhinitis NOS, rhinorrhea Skin and Subcutaneous Tissue Disorders: Clamminess, rash NOS, sweating increased Vascular Disorders: Hot flashes NOS Hepatic Encephalopathy The data described below reflect exposure to XIFAXAN 550 mg in 348 patients, including 265 exposed for 6 months and 202 exposed for more than a year (mean exposure was 364 days). The safety of XIFAXAN 550 mg taken two times a day for reducing the risk of overt hepatic encephalopathy recurrence in adult patients was evaluated in a 6-month placebo-controlled clinical trial (n = 140) and in a long term follow-up study (n = 280). The population studied had a mean age of 56.26 (range: 21-82) years; approximately 20% of the patients were ≥ 65 years old, 61% were male, 86% were White, and 4% were Black. Ninety-one percent of patients in the trial were taking lactulose concomitantly. All adverse reactions that occurred at an incidence ≥ 5% and at a higher incidence in XIFAXAN 550 mg-treated subjects than in the placebo group in the 6-month trial are provided in Table 2. (These include adverse events that may be attributable to the underlying disease). Table 2: Adverse Reactions Occurring in ≥ 5% of Patients Receiving XIFAXAN and at a Higher Incidence Than Placebo Number (%) of Patients MedDRA Preferred Term XIFAXAN Tablets 550 mg TWICE DAILY N = 140 Pla cebo N = 159 Edema peripheral 21 (15%) 13 (8%) Nausea 20 (14%) 21 (13%) Dizziness 18 (13%) 13 (8%) Fatigue 17 (12%) 18 (11%) Ascites 16 (11%) 15 (9%) Muscle spasms 13 (9%) 11 (7%) Pruritus 13 (9%) 10 (6%) Abdominal pain 12 (9%) 13 (8%) Abdominal distension 11 (8%) 12 (8%) Anemia 11 (8%) 6 (4%) Cough 10 (7%) 11 (7%) Depression 10 (7%) 8 (5%) Insomnia 10 (7%) 11 (7%) Nasopharyngitis 10 (7%) 10 (6%) Abdominal pain upper 9 (6%) 8 (5%) Arthralgia 9 (6%) 4 (3%) Back pain 9 (6%) 10 (6%) Constipation 9 (6%) 10 (6%) Dyspnea 9 (6%) 7 (4%) Pyrexia 9 (6%) 5 (3%) Rash 7 (5%) 6 (4%) The following adverse reactions, presented by body system, have also been reported in the placebo-controlled clinical trial in greater than 2% but less than 5% of patients taking XIFAXAN 550 mg taken orally two times a day for hepatic encephalopathy. The following includes adverse events occurring at a greater incidence than placebo, regardless of causal relationship to drug exposure. Ear and Labyrinth Disorders: Vertigo Gastrointestinal Disorders: Abdominal pain lower, abdominal tenderness, dry mouth, esophageal variceal bleed, stomach discomfort General Disorders and Administration Site Conditions: Chest pain, generalized edema, influenza like illness, pain NOS Infections and Infestations: Cellulitis , pneumonia, rhinitis, upper respiratory tract infection NOS Injury, Poisoning and Procedural Complications: Contusion, fall, procedural pain Investigations: Weight increased Metabolic and Nutritional Disorders: Anorexia, dehydration, hyperglycemia, hyperkalemia, hypoglycemia, hyponatremia Musculoskeletal, Connective Tissue, and Bone Disorders: Myalgia, pain in extremity Nervous System Disorders: Amnesia, disturbance in attention, hypoesthesia, memory impairment, tremor Psychiatric Disorders: Confusional state Respiratory, Thoracic, and Mediastinal Disorders: Epistaxis Vascular Disorders: Hypotension 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of XIFAXAN. Because these reactions are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to either their seriousness, frequency of reporting or causal connection to XIFAXAN. Infections and Infestations Cases of C. difficile -associated colitis have been reported [see Warnings and Precautions ( 5.2 )] . General Hypersensitivity reactions, including exfoliative dermatitis, rash, angioneurotic edema (swelling of face and tongue and difficulty swallowing), urticaria, flushing, pruritus and anaphylaxis have been reported. These events occurred as early as within 15 minutes of drug administration.

6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Travelers’ Diarrhea The safety of XIFAXAN 200 mg taken three times a day was evaluated in patients with travelers’ diarrhea consisting of 320 patients in two placebo-controlled clinical trials with 95% of patients receiving three or four days of treatment with XIFAXAN. The population studied had a mean age of 31.3 (18-79) years of which approximately 3% were ≥ 65 years old, 53% were male and 84% were White, 11% were Hispanic. Discontinuations due to adverse reactions occurred in 0.4% of patients. The adverse reactions leading to discontinuation were taste loss, dysentery, weight decrease, anorexia, nausea and nasal passage irritation. All adverse reactions for XIFAXAN 200 mg three times daily that occurred at a frequency ≥ 2% in the two placebo-controlled trials combined are provided in Table 1. (These include adverse reactions that may be attributable to the underlying disease.) Table 1. All Adverse Reactions With an Incidence ≥2% Among Patients Receiving XIFAXAN Tablets, 200 mg Three Times Daily, in Placebo-Controlled Studies MedDRA Preferred Term Number (%) of Patients XIFAXAN Tablets, 600 mg/day (N = 320) Placebo N = 228 *NOS: Not otherwise specified Flatulence 36 (11%) 45 (20%) Headache 31 (10%) 21 (9%) Abdominal Pain NOS * 23 (7%) 23 (10%) Rectal Tenesmus 23 (7%) 20 (9%) Defecation Urgency 19 (6%) 21 (9%) Nausea 17 (5%) 19 (8%) Constipation 12 (4%) 8 (4%) Pyrexia 10 (3%) 10 (4%) Vomiting NOS 7 (2%) 4 (2%) The following adverse reactions, presented by body system, have also been reported in <2% of patients taking XIFAXAN in the two placebo-controlled clinical trials where the 200 mg tablet was taken three times a day for travelers’ diarrhea. The following includes adverse reactions regardless of causal relationship to drug exposure. Blood and Lymphatic System Disorders: Lymphocytosis, monocytosis, neutropenia Ear and Labyrinth Disorders: Ear pain, motion sickness, tinnitus Gastrointestinal Disorders: Abdominal distension, diarrhea NOS, dry throat, fecal abnormality NOS, gingival disorder NOS, inguinal hernia NOS, dry lips, stomach discomfort General Disorders and Administration Site Conditions: Chest pain, fatigue, malaise, pain NOS, weakness Infections and Infestations: Dysentery NOS, respiratory tract infection NOS, upper respiratory tract infection NOS Injury and Poisoning: Sunburn Investigations: Aspartate aminotransferase increased, blood in stool, blood in urine, weight decreased Metabolic and Nutritional Disorders: Anorexia, dehydration Musculoskeletal, Connective Tissue, and Bone Disorders: Arthralgia, muscle spasms, myalgia, neck pain Nervous System Disorders: Abnormal dreams, dizziness, migraine NOS, syncope, loss of taste Psychiatric Disorders: Insomnia Renal and Urinary Disorders: Choluria, dysuria, hematuria, polyuria, proteinuria, urinary frequency Respiratory, Thoracic, and Mediastinal Disorders: Dyspnea NOS, nasal passage irritation, nasopharyngitis, pharyngitis, pharyngolaryngeal pain, rhinitis NOS, rhinorrhea Skin and Subcutaneous Tissue Disorders: Clamminess, rash NOS, sweating increased Vascular Disorders: Hot flashes NOS Hepatic Encephalopathy The data described below reflect exposure to XIFAXAN 550 mg in 348 patients, including 265 exposed for 6 months and 202 exposed for more than a year (mean exposure was 364 days). The safety of XIFAXAN 550 mg taken two times a day for reducing the risk of overt hepatic encephalopathy recurrence in adult patients was evaluated in a 6-month placebo-controlled clinical trial (n = 140) and in a long term follow-up study (n = 280). The population studied had a mean age of 56.26 (range: 21-82) years; approximately 20% of the patients were ≥ 65 years old, 61% were male, 86% were White, and 4% were Black. Ninety-one percent of patients in the trial were taking lactulose concomitantly. All adverse reactions that occurred at an incidence ≥ 5% and at a higher incidence in XIFAXAN 550 mg-treated subjects than in the placebo group in the 6-month trial are provided in Table 2. (These include adverse events that may be attributable to the underlying disease). Table 2: Adverse Reactions Occurring in ≥ 5% of Patients Receiving XIFAXAN and at a Higher Incidence Than Placebo Number (%) of Patients MedDRA Preferred Term XIFAXAN Tablets 550 mg TWICE DAILY N = 140 Pla cebo N = 159 Edema peripheral 21 (15%) 13 (8%) Nausea 20 (14%) 21 (13%) Dizziness 18 (13%) 13 (8%) Fatigue 17 (12%) 18 (11%) Ascites 16 (11%) 15 (9%) Muscle spasms 13 (9%) 11 (7%) Pruritus 13 (9%) 10 (6%) Abdominal pain 12 (9%) 13 (8%) Abdominal distension 11 (8%) 12 (8%) Anemia 11 (8%) 6 (4%) Cough 10 (7%) 11 (7%) Depression 10 (7%) 8 (5%) Insomnia 10 (7%) 11 (7%) Nasopharyngitis 10 (7%) 10 (6%) Abdominal pain upper 9 (6%) 8 (5%) Arthralgia 9 (6%) 4 (3%) Back pain 9 (6%) 10 (6%) Constipation 9 (6%) 10 (6%) Dyspnea 9 (6%) 7 (4%) Pyrexia 9 (6%) 5 (3%) Rash 7 (5%) 6 (4%) The following adverse reactions, presented by body system, have also been reported in the placebo-controlled clinical trial in greater than 2% but less than 5% of patients taking XIFAXAN 550 mg taken orally two times a day for hepatic encephalopathy. The following includes adverse events occurring at a greater incidence than placebo, regardless of causal relationship to drug exposure. Ear and Labyrinth Disorders: Vertigo Gastrointestinal Disorders: Abdominal pain lower, abdominal tenderness, dry mouth, esophageal variceal bleed, stomach discomfort General Disorders and Administration Site Conditions: Chest pain, generalized edema, influenza like illness, pain NOS Infections and Infestations: Cellulitis , pneumonia, rhinitis, upper respiratory tract infection NOS Injury, Poisoning and Procedural Complications: Contusion, fall, procedural pain Investigations: Weight increased Metabolic and Nutritional Disorders: Anorexia, dehydration, hyperglycemia, hyperkalemia, hypoglycemia, hyponatremia Musculoskeletal, Connective Tissue, and Bone Disorders: Myalgia, pain in extremity Nervous System Disorders: Amnesia, disturbance in attention, hypoesthesia, memory impairment, tremor Psychiatric Disorders: Confusional state Respiratory, Thoracic, and Mediastinal Disorders: Epistaxis Vascular Disorders: Hypotension

6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of XIFAXAN. Because these reactions are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to either their seriousness, frequency of reporting or causal connection to XIFAXAN. Infections and Infestations Cases of C. difficile -associated colitis have been reported [see Warnings and Precautions ( 5.2 )] . General Hypersensitivity reactions, including exfoliative dermatitis, rash, angioneurotic edema (swelling of face and tongue and difficulty swallowing), urticaria, flushing, pruritus and anaphylaxis have been reported. These events occurred as early as within 15 minutes of drug administration.

<table ID="idb296700-abeb-4b6d-875b-a5a4ef0ebaa7"> <caption>Table 1. All Adverse Reactions With an Incidence &#x2265;2% Among Patients Receiving XIFAXAN Tablets, 200 mg Three Times Daily, in Placebo-Controlled Studies</caption> <col/> <col/> <col/> <thead> <tr> <th rowspan="2" styleCode=" Botrule Toprule Lrule Rrule "> <content styleCode="bold">MedDRA Preferred Term</content> </th> <th align="center" colspan="2" styleCode=" Botrule Toprule Lrule Rrule "> <content styleCode="bold">Number (%) of Patients </content> </th> </tr> <tr> <th align="center" styleCode=" Botrule Toprule Lrule Rrule "> <content styleCode="bold"> <content styleCode="bold">XIFAXAN Tablets, 600 mg/day</content> <content styleCode="bold">(N = 320)</content> </content> </th> <th align="center" styleCode=" Botrule Toprule Lrule Rrule "> <content styleCode="bold"> Placebo</content> <content styleCode="bold">N = 228</content> </th> </tr> </thead> <tfoot> <tr> <td> <paragraph>*NOS: Not otherwise specified</paragraph> </td> </tr> </tfoot> <tbody> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Flatulence</paragraph> </td> <td align="center" styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>36 (11%)</paragraph> </td> <td align="center" styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>45 (20%)</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Headache</paragraph> </td> <td align="center" styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>31 (10%)</paragraph> </td> <td align="center" styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>21 (9%)</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Abdominal Pain NOS^* </paragraph> </td> <td align="center" styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>23 (7%)</paragraph> </td> <td align="center" styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>23 (10%)</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Rectal Tenesmus</paragraph> </td> <td align="center" styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>23 (7%)</paragraph> </td> <td align="center" styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>20 (9%)</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Defecation Urgency</paragraph> </td> <td align="center" styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>19 (6%)</paragraph> </td> <td align="center" styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>21 (9%)</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Nausea</paragraph> </td> <td align="center" styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>17 (5%)</paragraph> </td> <td align="center" styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>19 (8%)</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Constipation</paragraph> </td> <td align="center" styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>12 (4%)</paragraph> </td> <td align="center" styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>8 (4%)</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Pyrexia</paragraph> </td> <td align="center" styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>10 (3%)</paragraph> </td> <td align="center" styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>10 (4%)</paragraph> </td> </tr> <tr> <td styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>Vomiting NOS</paragraph> </td> <td align="center" styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>7 (2%)</paragraph> </td> <td align="center" styleCode=" Botrule Toprule Lrule Rrule "> <paragraph>4 (2%)</paragraph> </td> </tr> </tbody> </table>