ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS. The following adverse reactions have been identified from spontaneous reporting or clinical studies of barium sulfate administered orally. Because the reactions are reported voluntarily from population of uncertain size, it is not always possible to reliably estimate their frequency or to establish causal relationship to drug exposure:Nausea, vomiting, diarrhea and abdominal crampingSerious adverse reactions and fatalities include aspiration pneumonitis, barium sulfate impaction, intestinal perforation with consequent peritonitis and granuloma formation, vasovagal and syncopal episodes. Nausea, vomiting, diarrhea and abdominal cramping. Serious adverse reactions and fatalities include aspiration pneumonitis, barium sulfate impaction, intestinal perforation with consequent peritonitis and granuloma formation, vasovagal and syncopal episodes. Common adverse reactions include nausea, vomiting, diarrhea and abdominal cramping (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.

CLINICAL PHARMACOLOGY SECTION.

12 CLINICAL PHARMACOLOGY. 12.1 Mechanismof Action. Due to its high atomic number, barium (the active ingredient in VARIBARNECTAR) is opaque to x-rays and therefore acts as positive contrastagent for radiographic studies.. 12.2 Pharmacodynamics. Barium sulfate is biologicallyinert and has no known pharmacological effects.. 12.3 Pharmacokinetics. Under physiological conditions,barium sulfate passes through the gastrointestinal tract in an unchangedform and is absorbed only in pharmacologically insignificant amounts.

CONTRAINDICATIONS SECTION.

4 CONTRAINDICATIONS. VARIBAR NECTAR is contraindicated in patientswith: known or suspected perforation of the GI tractknown obstruction of the GI tracthigh risk of GI perforation such as those with recentprior GI 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 for aspiration such as those with known or suspectedtracheo-esophageal fistula or obtundationknown severe hypersensitivity to barium sulfate or any ofthe excipients of VARIBAR NECTAR. known or suspected perforation of the GI tract. known obstruction of the GI tract. high risk of GI perforation such as those with recentprior GI 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 for aspiration such as those with known or suspectedtracheo-esophageal fistula or obtundation. known severe hypersensitivity to barium sulfate or any ofthe excipients of VARIBAR NECTAR. Known or suspected perforation of the GI tract (4)Known obstruction of the GI tract (4)Conditions associated with high risk of GI perforation (4)Patients with tracheo-esophageal fistula (4)Known severe hypersensitivity to barium sulfate or any ofthe excipients of VARIBAR NECTAR (4). Known or suspected perforation of the GI tract (4). Known obstruction of the GI tract (4). Conditions associated with high risk of GI perforation (4). Patients with tracheo-esophageal fistula (4). Known severe hypersensitivity to barium sulfate or any ofthe excipients of VARIBAR NECTAR (4).

DESCRIPTION SECTION.

11 DESCRIPTION. VARIBAR NECTAR (barium sulfate) is radiographic contrast agent for oral administration that is supplied as 40% w/v, smooth, off- white to lightly colored free-flowing suspension with an apple aroma. The active ingredient is designated chemically as BaSO4 which has density of 4.5 g/cm3, molecular weight of 233.4 g/mol, and the following chemical structure:VARIBAR NECTAR has viscosity of 300 cPs and contains the following excipients: carboxymethylcellulose sodium, citric acid, glycerin, maltodextrin, natural and artificial apple flavor, polysorbate 80, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, xanthan gum, and xylitol.. barium-sulfate-structure.

DOSAGE & ADMINISTRATION SECTION.

2 DOSAGE AND ADMINISTRATION. For oral use only administered by syringe, spoon, or cup. The recommended dose is:Adults: mLPediatric patients months and older: 1-3 mLPediatric patients younger than months of age: 0.5-1mLMaximum cumulative dose: 30 mLDuring single modified barium swallow examination, multipledoses of VARIBAR NECTAR may be administered. (2). For oral use only administered by syringe, spoon, or cup. The recommended dose is:. Adults: mL. Pediatric patients months and older: 1-3 mL. Pediatric patients younger than months of age: 0.5-1mL. Maximum cumulative dose: 30 mL. During single modified barium swallow examination, multipledoses of VARIBAR NECTAR may be administered. (2). 2.1 Recommended Dosing. The recommended dose of VARIBAR NECTAR administered orally by syringe, spoon, or cup:Adults mLPediatric patients months and olde 1-3 mLPediatric patients younger than months of age 0.5-1 mL(This amount may be administered by an oral syringe or, alternatively, an infant bottle) During single modified barium swallow examination, multiple doses of VARIBAR NECTAR may be administered as appropriate to assess the patient during multiple swallows and different radiographic views.The maximum cumulative dose is 30 mL.Once opened, write the discard after date on the immediate container label. Discard any unused product after 21 days.. The recommended dose of VARIBAR NECTAR administered orally by syringe, spoon, or cup:Adults mLPediatric patients months and olde 1-3 mLPediatric patients younger than months of age 0.5-1 mL(This amount may be administered by an oral syringe or, alternatively, an infant bottle) Adults mL. Pediatric patients months and olde 1-3 mL. Pediatric patients younger than months of age 0.5-1 mL(This amount may be administered by an oral syringe or, alternatively, an infant bottle). During single modified barium swallow examination, multiple doses of VARIBAR NECTAR may be administered as appropriate to assess the patient during multiple swallows and different radiographic views.. The maximum cumulative dose is 30 mL.. Once opened, write the discard after date on the immediate container label. Discard any unused product after 21 days.. 2.2 ImportantAdministration Instructions. For oral use only.Encourage patients to hydrate following thebarium sulfate procedure.

DOSAGE FORMS & STRENGTHS SECTION.

3 DOSAGE FORMS AND STRENGTHS. Oral Suspension: smooth, off-white to lightly colored free-flowing suspension with an apple aroma for oral administration supplied in multiple-dose HDPE plastic bottles containing 240 mL of barium sulfate (40% w/v) and multiple-dose glass bottles containing 70 mL of barium sulfate (40% w/v).. Oral suspension 40% (w/v) in 240 mL multiple-dose HDPE plastic bottle or 70 mL multiple dose glass bottle for oral administration (3). Oral suspension 40% (w/v) in 240 mL multiple-dose HDPE plastic bottle or 70 mL multiple dose glass bottle for oral administration (3).

HOW SUPPLIED SECTION.

16 HOW SUPPLIED/STORAGE AND HANDLING. How SuppliedVARIBAR NECTAR is smooth, off-white to lightly colored free-flowing suspension with an apple aroma for oral administration supplied in multiple-dose HDPE plastic bottles containing 240 mL of barium sulfate (40% w/v) and multiple-dose glass bottles containing 70 mL of barium sulfate (40% w/v).Provided as: 12 240 mL bottles (NDC 32909-116-00); 12 70 mL bottles (32909-116-55).Storage and HandlingStore at USP controlled room temperature 20C to 25C (68 to 77 F). Protect from freezing.Once opened, VARIBAR NECTAR may be used for up to 21 days when stored at USP controlled room temperature, 20C to 25C (68 to 77 F).

INDICATIONS & USAGE SECTION.

1 INDICATIONSAND USAGE. VARIBAR NECTAR is indicated for use in modified barium swallow examinationsto evaluate the oral and pharyngeal function and morphology in adultand pediatric patients.. VARIBAR NECTAR is radiographiccontrast 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 or slow gastrointestinal passage [see Warnings and Precautions (5.3)].Seek medical attention for any delayed onset of hypersensitivity: rash, urticaria, or respiratory difficulty [see Warnings and Precautions (5.1)].Rx onlyManufactured forBracco Diagnostics Inc.Princeton, NJ 08540by EZEM Canada IncAnjou (Quebec) Canada H1J 2Z4Revised May 2025CL10FD-03. Maintain adequate hydration [see Dosage and Administration (2.2) and Warnings and Precautions (5.3)].. Seek medical attention for worsening of constipation or slow gastrointestinal passage [see Warnings and Precautions (5.3)].. Seek medical attention for any delayed onset of hypersensitivity: rash, urticaria, or respiratory difficulty [see Warnings and Precautions (5.1)].

NONCLINICAL TOXICOLOGY SECTION.

13 NONCLINICAL TOXICOLOGY. 13.1 Carcinogenesis,Mutagenesis, Impairment of Fertility. No animal studies have been performed toevaluate the carcinogenic potential of barium sulfate or potentialeffects on fertility.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Varibar(R) Nectar Barium Sulfate Oral SuspensionNDC: 32909-116-00240 mL Varibar(R) Nectar Internal Label240 mL Varibar(R) Nectar External Label NDC: 32909-116-5570 mL Varibar(R) Nectar Internal Label70 mL Varibar(R) Nectar External Label. Varibar Nectar 240 mL Internal Label. Varibar Nectar 240 mL External Label. Varibar Nectar 70 mL Internal Label. Varibar Nectar 70 mL External Label.

SPL UNCLASSIFIED SECTION.

2.1 Recommended Dosing. The recommended dose of VARIBAR NECTAR administered orally by syringe, spoon, or cup:Adults mLPediatric patients months and olde 1-3 mLPediatric patients younger than months of age 0.5-1 mL(This amount may be administered by an oral syringe or, alternatively, an infant bottle) During single modified barium swallow examination, multiple doses of VARIBAR NECTAR may be administered as appropriate to assess the patient during multiple swallows and different radiographic views.The maximum cumulative dose is 30 mL.Once opened, write the discard after date on the immediate container label. Discard any unused product after 21 days.. The recommended dose of VARIBAR NECTAR administered orally by syringe, spoon, or cup:Adults mLPediatric patients months and olde 1-3 mLPediatric patients younger than months of age 0.5-1 mL(This amount may be administered by an oral syringe or, alternatively, an infant bottle) Adults mL. Pediatric patients months and olde 1-3 mL. Pediatric patients younger than months of age 0.5-1 mL(This amount may be administered by an oral syringe or, alternatively, an infant bottle). During single modified barium swallow examination, multiple doses of VARIBAR NECTAR may be administered as appropriate to assess the patient during multiple swallows and different radiographic views.. The maximum cumulative dose is 30 mL.. Once opened, write the discard after date on the immediate container label. Discard any unused product after 21 days.

USE IN SPECIFIC POPULATIONS SECTION.

8 USE IN SPECIFIC POPULATIONS. 8.1 Pregnancy. Risk SummaryVARIBAR NECTAR is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology (12.3)].. 8.2 Lactation. Risk SummaryVARIBAR NECTAR is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the infant to VARIBAR NECTAR [see Clinical Pharmacology (12.3)].. 8.4 Pediatric Use. The efficacy of VARIBAR NECTAR in pediatric patients from birth to less than 17 years of age is based on successful opacification of the oropharynx during modified barium swallow examinations [see Clinical Pharmacology (12.1)]. Safety and dosing recommendations in pediatric patients are based on clinical experience [see Dosage and Administration (2.1)].VARIBAR NECTAR is contraindicated in pediatric patients with tracheo-esophageal fistula [see Contraindications (4)]. Pediatric patients with history of asthma or food allergies may be at increased risk for development of hypersensitivity reactions [see Warnings and Precautions (5.1)]. Patients with cystic fibrosis or Hirschsprung disease should be monitored for small bowel obstruction after use [see Warnings and Precautions (5.3)].. 8.5 GeriatricUse. Clinicalstudies of VARIBAR NECTAR do not include sufficient numbers of subjectsaged 65 and over to determine whether they respond differently fromyounger subjects. Other reported clinical experience has not identifieddifferences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious,usually starting at the low end of the dosing range, reflecting thegreater frequency of decreased hepatic, renal, or cardiac function,and of concomitant disease or other drug therapy.

WARNINGS AND PRECAUTIONS SECTION.

5 WARNINGS AND PRECAUTIONS. Hypersensitivity reactions: Emergency equipment and trainedpersonnel should be immediately available (5.1)Intra-abdominal barium leakage: May occur in conditionssuch as GI fistula, ulcer, inflammatory bowel disease, appendicitisor diverticulitis, severe stenosis or obstructing lesions of the GItract (5.2)Delayed GI transit and obstruction: Patients should maintainadequate hydration in days following barium sulfate procedure toavoid obstruction 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 barium leakage: May occur in conditionssuch as GI fistula, ulcer, inflammatory bowel disease, appendicitisor diverticulitis, severe stenosis or obstructing lesions of the GItract (5.2). Delayed GI transit and obstruction: Patients should maintainadequate hydration in days following barium sulfate procedure toavoid obstruction or impaction (5.3). Aspiration pneumonitis: Aspiration may occur during themodified barium swallow examination. Monitor the patient for aspiration(5.4). 5.1 HypersensitivityReactions. Barium sulfate preparations contain number of excipients, includingnatural and artificial flavors and may induce serious hypersensitivityreactions. The manifestations include hypotension, bronchospasm andother respiratory impairments, dermal reactions including rashes,urticaria and itching. history of bronchial asthma, atopy or aprevious reaction to contrast agent may increase the risk for hypersensitivityreactions. Emergency equipment and trained personnel should be immediatelyavailable for treatment of hypersensitivity reaction.. 5.2 Intra-abdominalBarium Leakage. The use of VARIBAR NECTAR is contraindicated in patients at highrisk of perforation of the GI tract [see Contraindications(4)]. Administration of VARIBARNECTAR may result in leakage of barium at any level of the GI tractin the presence of conditions such as carcinomas, GI fistula, inflammatorybowel disease, gastric or duodenal ulcer, appendicitis or diverticulitis,and in patients with severe stenosis at any level of the GI tract,especially if it is distal to the stomach. The barium leakage hasbeen associated with peritonitis and granuloma formation.. 5.3 DelayedGastrointestinal Transit and Obstruction. Orally administered barium sulfate may accumulateproximal to constricting lesion of the colon, causing obstructionor impaction with development of baroliths (inspissated barium associatedwith feces) and may lead to abdominal pain, appendicitis, bowel obstruction,or rarely perforation. Patients with the following conditions areat higher risk for developing obstruction or baroliths: severe stenosisat any level of the GI tract, impaired GI motility, electrolyte imbalance,dehydration, on low residue diet, taking medications that delayGI motility, constipation, pediatric patients with cystic fibrosisor Hirschsprung disease, and the elderly [see Use in SpecificPopulations (8.4, 8.5)]. To reduce the risk ofdelayed GI transit and obstruction, patients should maintain adequatehydration following barium sulfate procedure.. 5.4 AspirationPneumonitis. The use of VARIBAR NECTAR is contraindicated in patients with tracheo-esophagealfistula [see Contraindications (4)]. Oral administration of barium is associated with aspirationpneumonitis, especially in patients with history of food aspirationor with compromised swallowing mechanism. Vomiting following oraladministration of barium sulfate may lead to aspiration pneumonitis.In patients at risk for aspiration,begin the procedure with small ingested volume of VARIBAR NECTAR.Aspiration of small volumes of barium sulfate may occur during themodified barium swallow procedure in some patients. Monitor the patientclosely for aspiration, discontinue administration if aspiration issuspected and monitor for development of aspiration pneumonitis.. 5.5 SystemicEmbolization. Barium sulfate products may occasionally intravasate into the venousdrainage of the large bowel and enter the circulation as bariumembolus leading to potentially fatal complications which includesystemic and pulmonary embolism, disseminated intravascular coagulation,septicemia and prolonged severe hypotension. Although this complicationis exceedingly uncommon after oral administration of barium sulfateproducts, monitor patients for potential intravasation when administeringbarium sulfate.