Varibar Nectar

Varibar Nectar is an FDA-registered drug product whose active ingredient is BARIUM SULFATE. It is labelled by E-Z-EM Canada Inc taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 32909-116, application NDA208143, label effective 20260515. It is one of 10 FDA drug label records sharing the active ingredient BARIUM SULFATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing BARIUM SULFATE are most often described in connection with: varibar nectar, modified barium, swallow examinations, pharyngeal function, morphology adult, pediatric patients, radiographic contrast, agent indicated. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE VARIBAR NECTAR is indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients. VARIBAR NECTAR is a radiographic contrast agent indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients. ( 1 )

2 DOSAGE AND ADMINISTRATION For oral use only – administered by syringe, spoon, or cup. The recommended dose is: Adults: 5 mL Pediatric patients 6 months and older: 1-3 mL Pediatric patients younger than 6 months of age: 0.5-1 mL Maximum cumulative dose: 30 mL During a single modified barium swallow examination, multiple doses 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 5 mL Pediatric patients 6 months and olde 1-3 mL Pediatric patients younger than 6 months of age 0.5-1 mL (This amount may be administered by an oral syringe or, alternatively, an infant bottle) During a 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 Important Administration Instructions For oral use only. Encourage patients to hydrate following the barium sulfate procedure.

4 CONTRAINDICATIONS VARIBAR NECTAR is contraindicated in patients with: known or suspected perforation of the GI tract known obstruction of the GI tract high risk of GI perforation such as those with a recent prior 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 suspected tracheo-esophageal fistula or obtundation known severe hypersensitivity to barium sulfate or any of the 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 of the excipients of VARIBAR NECTAR ( 4 )

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 a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure: 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

FDA lists 10 drug label records with BARIUM SULFATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Varibar Nectar used for?
1 INDICATIONS AND USAGE VARIBAR NECTAR is indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients. VARIBAR NECTAR is a radiographic contrast agent indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients. ( 1 )

Who makes Varibar Nectar?
E-Z-EM Canada Inc is the labeler of record for Varibar Nectar. 10 FDA label records share the active ingredient BARIUM SULFATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Varibar Nectar come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Varibar Nectar prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing BARIUM SULFATE?
Yes. 10 FDA drug label records list BARIUM SULFATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Varibar Nectar been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.