Varibar Pudding

Varibar Pudding 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 32909-125, application NDA208844, 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 pudding, modified barium, swallow examinations, pharyngeal function, morphology adult, pediatric patients, months age, radiographic contrast. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE VARIBAR PUDDING is indicated for modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients 6 months of age and older. VARIBAR PUDDING 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 6 months of age and older ( 1 )

2 DOSAGE AND ADMINISTRATION For oral use only – administered by syringe or spoon ( 2.1 ) Adults: 5 mL Pediatric patients: 1-3 mL Multiple doses may be administered Maximum cumulative dose : 30 mL 2.1 Recommended Dosing The recommended oral dose of VARIBAR PUDDING delivered by oral syringe or spoon: Adults 5 mL Pediatric patients 1-3 mL During a single modified barium swallow examination, multiple doses of VARIBAR PUDDING may be administered as appropriate, to assess the patient during multiple swallows and different radiographic views. The maximum cumulative dose is 30 mL oral. Once opened, write the discard after date on the immediate container label. Discard any unused product after 21 days. 2.2 Important Administration Instructions Advise patients to hydrate following the barium sulfate procedure. Advise patient at risk for constipation or delayed gastrointestinal transit to monitor for worsening of their condition after administration of barium sulfate and seek medical attention if worsening and advise using laxatives to enhance gastrointestinal transit.

4 CONTRAINDICATIONS VARIBAR PUDDING is contraindicated in patients with: - known or suspected perforation of the gastrointestinal (GI) tract; - known obstruction of the GI tract; - high risk of GI perforation such as those with a recent 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 hypersensitivity to barium sulfate or any of the excipients of VARIBAR PUDDING. VARIBAR PUDDING is contraindicated in patients with: Known or suspected perforation of the gastrointestinal (GI) tract ( 4 ) Conditions associated with high risk for GI perforation ( 4 ) Known obstruction of the GI tract ( 4 ) Patients with trachea-esophageal fistula ( 4 ) Known hypersensitivity to barium sulfate or any of the excipients of VARIBAR PUDDING ( 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 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 Pudding used for?
1 INDICATIONS AND USAGE VARIBAR PUDDING is indicated for modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients 6 months of age and older. VARIBAR PUDDING 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 …

Who makes Varibar Pudding?
E-Z-EM Canada Inc is the labeler of record for Varibar Pudding. 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 Pudding 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 Pudding 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 Pudding 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.