ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS. The following adverse reactionshave been identified from spontaneous reporting or clinical studiesof barium sulfate administered orally. Because the reactions are reportedvoluntarily from population of uncertain size, it is not alwayspossible to reliably estimate their frequency or to establish causalrelationship to drug exposure:Nausea, vomiting, diarrhea and abdominal crampingSerious adverse reactions and fatalities include aspirationpneumonitis, barium sulfate impaction, intestinal perforation withconsequent peritonitis and granuloma formation, vasovagal and syncopalepisodes. Nausea, vomiting, diarrhea and abdominal cramping. Serious adverse reactions and fatalities include aspirationpneumonitis, barium sulfate impaction, intestinal perforation withconsequent peritonitis and granuloma formation, vasovagal and syncopalepisodes. Common adverse reactions includenausea, vomiting, diarrhea and abdominal cramp (6)To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch See 17 for PATIENT COUNSELING INFORMATION.

CLINICAL PHARMACOLOGY SECTION.

12 CLINICALPHARMACOLOGY. 12.1 Mechanism of Action. Due to its high atomic number, barium (theactive ingredient in VARIBAR THIN HONEY) is opaque to x-rays and thereforeacts as positive contrast agent for radiographic studies.. 12.2 Pharmacodynamics. Barium sulfate is biologically inert andhas no known pharmacological effects.. 12.3 Pharmacokinetics. Under physiological conditions, barium sulfatepasses through the gastrointestinal tract in an unchanged form andis absorbed only in small, pharmacologically insignificant amounts.

CONTRAINDICATIONS SECTION.

4 CONTRAINDICATIONS. VARIBAR THIN HONEY is contraindicatedin patients with:known or suspected perforation of the gastrointestinal (GI)tractknown obstruction of the GI tracthigh risk of GI perforation such as those with recentGI perforation, acute GI hemorrhage or ischemia, toxic megacolon,severe ileus, post GI surgery or biopsy, acute GI injury or burn,or recent radiotherapy to the pelvishigh risk of aspiration such as those with known or suspectedtracheo-esophageal fistula or obtundationknown severe hypersensitivity to barium sulfate or any ofthe excipients of VARIBAR THIN HONEY. known or suspected perforation of the gastrointestinal (GI)tract. known obstruction of the GI tract. high risk of GI perforation such as those with recentGI perforation, acute GI hemorrhage or ischemia, toxic megacolon,severe ileus, post GI surgery or biopsy, acute GI injury or burn,or recent radiotherapy to the pelvis. high risk of aspiration such as those with known or suspectedtracheo-esophageal fistula or obtundation. known severe hypersensitivity to barium sulfate or any ofthe excipients of VARIBAR THIN HONEY. Known or suspected perforation of the gastrointestinal (GI)tract (4)Known obstruction of the GI tract (4)Conditions associated with high risk of GI perforation oraspiration (4)Known hypersensitivity to barium sulfate or any of the excipientsof VARIBAR THIN HONEY (4). Known or suspected perforation of the gastrointestinal (GI)tract (4). Known obstruction of the GI tract (4). Conditions associated with high risk of GI perforation oraspiration (4). Known hypersensitivity to barium sulfate or any of the excipientsof VARIBAR THIN HONEY (4).

DESCRIPTION SECTION.

11 DESCRIPTION. VARIBAR THIN HONEY (barium sulfate)is radiographic contrast agent that is supplied as an off-whiteto lightly colored suspension (40% w/v) with an apple aroma for oraladministration. The active ingredient barium sulfate is designatedchemically as BaSO4 with molecular weightof 233.4 g/mol, density of 4.5 g/cm3,and the following chemical structure:VARIBAR THIN HONEY hasa viscosity of 1500 cPs and contains the following excipients:carboxymethylcellulose sodium, citric acid, glycerin, natural andartificial apple flavor, polysorbate 80, potassium sorbate, purifiedwater, saccharin sodium, simethicone emulsion, sodium benzoate, sodiumcitrate, starch modified (from corn), xanthan gum, and xylitol.. barium-sulfate-structure.

DOSAGE & ADMINISTRATION SECTION.

2 DOSAGE AND ADMINISTRATION. For oral use only administer by syringe, spoon, or cup. The recommended dose is:Adults: mLPediatric patients: to mL During single modified barium swallow examination, multipledoses may be administeredMaximum cumulative dose: 30 mL (2). For oral use only administer by syringe, spoon, or cup. The recommended dose is:Adults: mLPediatric patients: to mL Adults: mL. Pediatric patients: to mL. During single modified barium swallow examination, multipledoses may be administered. Maximum cumulative dose: 30 mL (2). 2.1 Recommended Dosing. The recommended dose of VARIBAR THIN HONEY administeredorally by syringe, spoon, or cup is: Adults mLPediatric patients to mL During single modified barium swallow examination, multipledoses of VARIBAR THIN HONEY may be administered, to assess the patientduring multiple swallows and different radiographic views.The maximum cumulative dose is 30 mL.Once opened, write the discard after date on the immediatecontainer label. Discard any unused product after 21 days.. The recommended dose of VARIBAR THIN HONEY administeredorally by syringe, spoon, or cup is: Adults mLPediatric patients to mL Adults mL. Pediatric patients to mL. During single modified barium swallow examination, multipledoses of VARIBAR THIN HONEY may be administered, to assess the patientduring multiple swallows and different radiographic views.. The maximum cumulative dose is 30 mL.. Once opened, write the discard after date on the immediatecontainer label. Discard any unused product after 21 days.. 2.2 Important Administration Instructions. For oral use onlyAdvise patients to hydrate following the barium sulfateprocedure.. For oral use only. Advise patients to hydrate following the barium sulfateprocedure.

DOSAGE FORMS & STRENGTHS SECTION.

3 DOSAGE FORMS AND STRENGTHS. Oral suspension: barium sulfate(40% w/v) supplied in multiple-dose plastic bottle as ready-to-usesuspension for oral administration. Each bottle contains 250 mL ofsuspension.. Oral suspension: barium sulfate(40% w/v) supplied in multiple-dose bottle for oral administration(3).

HOW SUPPLIED SECTION.

16 HOW SUPPLIED/STORAGEAND HANDLING. 16.1 How Supplied VARIBAR THIN HONEY is supplied as suspensionin multiple-dose polyethylene bottle containing 250 mL of bariumsulfate (40 w/v).Provided as: 12 250 mL bottles (NDC 32909-121-07)16.2 Storage and HandlingStore at USP controlled roomtemperature 20 to 25C (68 to 77 F). Protect from freezing.Once opened, VARIBAR THIN HONEYmay be used for up to 21 days when stored at USP controlled room temperature,20 to 25C (68 to 77 F).

INDICATIONS & USAGE SECTION.

1 INDICATIONS AND USAGE. VARIBAR THIN HONEY is indicatedfor modified barium swallow examinations to evaluate the oral andpharyngeal function and morphology in adult and pediatric patients.. VARIBAR THIN HONEY is radiopaquecontrast agent indicated for use in modified barium swallow examinationsto evaluate the oral and pharyngeal function and morphology in adultand pediatric patients (1).

INFORMATION FOR PATIENTS SECTION.

17 PATIENT COUNSELING INFORMATION. After administration, advise patients to:Maintain adequate hydration [see Dosage and Administration(2.2) and Warnings and Precautions(5.3)].Seek medical attention for worsening of constipation orslow gastrointestinal passage [see Warnings and Precautions(5.3)].Seek medical attention for any delayed onset of hypersensitivity:rash, urticaria, or respiratory difficulty [see Warnings andPrecautions (5.1)].Rx onlyManufactured byEZEMCanada IncAnjou (Quebec) Canada H1J 2Z4ForBracco Diagnostics Inc.Monroe Township, NJ 08831VARIBAR is registered trademark of E-Z-EM,Inc.January 2018. Maintain adequate hydration [see Dosage and Administration(2.2) and Warnings and Precautions(5.3)].. Seek medical attention for worsening of constipation orslow gastrointestinal passage [see Warnings and Precautions(5.3)].. Seek medical attention for any delayed onset of hypersensitivity:rash, urticaria, or respiratory difficulty [see Warnings andPrecautions (5.1)].

NONCLINICAL TOXICOLOGY SECTION.

13 NONCLINICALTOXICOLOGY. 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility. No animal studies have beenperformed to evaluate the carcinogenic potential of barium sulfateor potential effects on fertility.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

VaribarThin Honey Box. varibar-thin-honey-box.

SPL UNCLASSIFIED SECTION.

2.1 Recommended Dosing. The recommended dose of VARIBAR THIN HONEY administeredorally by syringe, spoon, or cup is: Adults mLPediatric patients to mL During single modified barium swallow examination, multipledoses of VARIBAR THIN HONEY may be administered, to assess the patientduring multiple swallows and different radiographic views.The maximum cumulative dose is 30 mL.Once opened, write the discard after date on the immediatecontainer label. Discard any unused product after 21 days.. The recommended dose of VARIBAR THIN HONEY administeredorally by syringe, spoon, or cup is: Adults mLPediatric patients to mL Adults mL. Pediatric patients to mL. During single modified barium swallow examination, multipledoses of VARIBAR THIN HONEY may be administered, to assess the patientduring multiple swallows and different radiographic views.. The maximum cumulative dose is 30 mL.. Once opened, write the discard after date on the immediatecontainer label. Discard any unused product after 21 days.

USE IN SPECIFIC POPULATIONS SECTION.

8 USEIN SPECIFIC POPULATIONS. 8.1 Pregnancy. Risk SummaryVARIBAR THIN HONEY is not absorbed systemicallyfollowing oral administration, and maternal use is not expected toresult in fetal exposure to the drug.. 8.2 Lactation. Risk SummaryVARIBAR THIN HONEY is not absorbed systemicallyby the mother following oral administration, and breastfeeding isnot expected to result in exposure of the infant to the drug.. 8.4 Pediatric Use. The efficacy of VARIBAR THIN HONEY in pediatricpatients is based on successful opacification of the pharynx duringmodified barium swallow examinations [see Clinical Pharmacology(12.1)]. Safety and dosingrecommendations in pediatric patients are based on clinical experience.VARIBAR THIN HONEY is contraindicatedin pediatric patients with trachea-esophageal fistula. [seeContraindications (4)]. Pediatricpatients with history of asthma or food allergies may be at increasedrisk for development of hypersensitivity reactions [see Warningsand Precautions (5.1)]. Monitorpatients with cystic fibrosis or Hirschsprung disease for bowel obstructionafter use [see Warnings and Precautions (5.3)].. 8.5 Geriatric Use. Clinical studies of VARIBAR THIN HONEY didnot include sufficient numbers of subjects aged 65 and over to determinewhether they respond differently from younger subjects. Other reportedclinical experience has not identified differences in responses betweenthe elderly and younger patients. In general, dose selection for anelderly patient should be cautious, usually starting at the low endof the dosing range, reflecting the greater frequency of decreasedhepatic, renal, or cardiac function, and of concomitant disease orother drug therapy.

WARNINGS AND PRECAUTIONS SECTION.

5 WARNINGS AND PRECAUTIONS. Hypersensitivity reactions: Emergency equipment and trainedpersonnel should be immediately available (5.1)Intra-abdominal leakage: May occur in conditions such asGI fistula, ulcer, inflammatory bowel disease, appendicitis or diverticulitis,severe stenosis or obstructing lesions of the GI tract (5.2)Delayed GI transit and obstruction: Patients should maintainadequate hydration in days following barium sulfate procedure to avoidobstruction or impaction (5.3)Aspiration pneumonitis: Aspiration may occur during themodified barium swallow examination, monitor the patient for aspiration(5.4). Hypersensitivity reactions: Emergency equipment and trainedpersonnel should be immediately available (5.1). Intra-abdominal leakage: May occur in conditions such asGI fistula, ulcer, inflammatory bowel disease, appendicitis or diverticulitis,severe stenosis or obstructing lesions of the GI tract (5.2). Delayed GI transit and obstruction: Patients should maintainadequate hydration in days following barium sulfate procedure to avoidobstruction or impaction (5.3). Aspiration pneumonitis: Aspiration may occur during themodified barium swallow examination, monitor the patient for aspiration(5.4). 5.1 Hypersensitivity Reactions. Barium sulfate preparations contain numberof excipients, including natural and artificial flavors and may induceserious hypersensitivity reactions. The manifestations include hypotension,bronchospasm and other respiratory impairments, and dermal reactionsincluding rashes, urticaria and itching. history of bronchial asthma,atopy, food allergies, or previous reaction to contrast agentmay increase the risk for hypersensitivity reactions. Emergency equipmentand trained personnel should be immediately available for treatmentof hypersensitivity reaction.. 5.2 Intra-abdominal Barium Leakage. The use of VARIBAR THIN HONEY is contraindicatedin patients at high risk of perforation of the GI tract [seeContraindications (4)]. Administrationof VARIBAR THIN HONEY may result in leakage of barium from the GItract in the presence of conditions such as carcinomas, GI fistula,inflammatory bowel disease, gastric or duodenal ulcer, appendicitis,or diverticulitis, and in patients with severe stenosis at any levelof the GI tract, especially if it is distal to the stomach. The bariumleakage has been associated with peritonitis and granuloma formation.. 5.3 Delayed Gastrointestinal Transit and Obstruction. Orally administered barium sulfatemay accumulate proximal to constricting lesion of the colon, causingobstruction or impaction with development of baroliths (inspissatedbarium associated with feces) and may lead to abdominal pain, appendicitis,bowel obstruction, or rarely perforation. Patients with the followingconditions are at higher risk for developing obstruction or baroliths: severe stenosis at any level of the GI tract, impaired GI motility,electrolyte imbalance, dehydration, on low residue diet, takingmedications that delay GI motility, constipation, pediatric patientswith cystic fibrosis or Hirschsprung disease, and the elderly [see Use in Specific Populations (8.4, 8.5)]. To reduce therisk of delayed GI transit and obstruction, patients should maintainadequate hydration after the barium sulfate procedure.. 5.4 Aspiration Pneumonitis. The use of VARIBAR THIN HONEY is contraindicatedin patients with trachea-esophageal fistula [see Contraindications(4)]. Oral administrationof barium is associated with aspiration pneumonitis, especially inpatients with history of food aspiration or with compromised swallowingmechanism. Vomiting following oral administration of barium sulfatemay lead to aspiration pneumonitis.In patients at risk for aspiration, beginthe procedure with small ingested volume of VARIBAR THIN HONEY.Monitor the patient closely for aspiration, discontinue administrationof VARIBAR THIN HONEY if aspiration is suspected, and monitor fordevelopment of aspiration pneumonitis.. 5.5 Systemic Embolization. Barium sulfate products may occasionallyintravasate into the venous drainage of the GI tract and enter thecirculation as barium embolus leading to potentially fatal complicationswhich include systemic and pulmonary embolism, disseminated intravascularcoagulation, septicemia and prolonged severe hypotension. Althoughthis complication is exceedingly uncommon after oral administrationof barium sulfate suspension, monitor patients for potential intravasationwhen administering barium sulfate.