Varibar Thin Liquid

Varibar Thin Liquid 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 32909-105, application NDA208036, label effective 20260415. 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 thin, modified barium, swallow examinations, pharyngeal function, morphology adult, pediatric patients, liquid indicated, radiopaque contrast. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE VARIBAR THIN LIQUID is indicated for modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients. VARIBAR THIN LIQUID is a radiopaque 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– once reconstituted, administer by infant bottle, syringe, spoon, or cup. The recommended dose is: ● Adults: 5 mL ● Pediatric patients 6 months and older: 1 mL to 3 mL ● Pediatric patients younger than 6 months of age: 0.5 mL to 1 mL During a single modified barium swallow examination, multiple doses may be administered Maximum cumulative dose: 80 mL ( 2.1 ) Must reconstitute supplied powder with water prior to use. See Full Prescribing Information for reconstitution instructions ( 2.2 ) 2.1 Recommended Dosing and Administration Instructions The recommended dose of reconstituted VARIBAR THIN LIQUID administered orally by infant bottle, syringe, spoon, or cup is: Adults: 5 mL Pediatric patients 6 months and older: 1 mL to 3 mL Pediatric patients younger than 6 months of age: 0.5 mL to 1 mL During a single modified barium swallow examination, multiple doses of VARIBAR THIN LIQUID may be administered, to assess the patient during multiple swallows and different radiographic views. The maximum cumulative dose is 80 mL. For oral use only Advise patients to hydrate following the barium sulfate procedure. 2.2 Instructions for Reconstitution The VARIBAR THIN LIQUID powder must be reconstituted prior to administration by a healthcare provider according to the following instructions: Add water to the fill line on the bottle label Replace the lid securely Invert the bottle and tap with fingers to mix the powder into the water Shake vigorously for 30 seconds. Let stand for 5 minutes Refill with water to the fill line on the bottle label and reshake thoroughly. Once reconstituted, write the discard after date on the immediate container label. After reconstitution, store in refrigerator at 2°C to 8°C (36ºF to 46ºF) for up to 72 hours. Reconstitution yields approximately 300 mL of VARIBAR THIN LIQUID oral suspension containing 0.4 grams of barium sulfate per mL (40% w/v) and should be homogeneous and white to lightly colored.

4 CONTRAINDICATIONS VARIBAR THIN LIQUID 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 of 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 THIN LIQUID 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 or aspiration ( 4 ) Known hypersensitivity to barium sulfate or any of the excipients of VARIBAR THIN LIQUID ( 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 Thin Liquid used for?
1 INDICATIONS AND USAGE VARIBAR THIN LIQUID is indicated for modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients. VARIBAR THIN LIQUID is a radiopaque 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 Thin Liquid?
E-Z-EM Canada Inc is the labeler of record for Varibar Thin Liquid. 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 Thin Liquid 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 Thin Liquid 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 Thin Liquid 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.