E-Z-HD

E-Z-HD 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 32909-764, 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: double-contrast radiographic, esophagus stomach, gastrointestinal tract, patients years, usage e-z-hd, duodenum help, contrast agent. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE E-Z-HD is indicated for use in double-contrast radiographic examinations of the esophagus, stomach and duodenum to help visualize the gastrointestinal (GI) tract in patients 12 years and older. E-Z-HD, a radiographic contrast agent, is indicated for use in double-contrast radiographic examinations of the esophagus, stomach and duodenum to visualize the gastrointestinal (GI) tract in patients 12 years and older ( 1 )

2 DOSAGE AND ADMINISTRATION Recommended reconstituted oral dose for adults and pediatric patients 12 years and older is between 65 mL to 135 mL (155 to 321 grams of barium sulfate, respectively) ( 2.1 ) Must reconstitute supplied powder with water prior to use. See Full Prescribing Information for reconstitution instructions ( 2.2 ) 2.1 Recommended Dosage The recommended dose of reconstituted E-Z-HD for adults and pediatric patients 12 years and olderis between 65 and 135 mL given orally (155 to 321 grams of barium sulfate, respectively). Volumes closer to 65 mL are recommended for the examination of the esophagus and volumes up to 135 mL are recommended for examination of the entire upper GI tract. 2.2 Instructions for Reconstitution The E-Z-HD powder must be reconstituted prior to administration by a healthcare provider according to the following instructions: Accurately measure 65 mL of water and add this water to the bottle containing the supplied E-Z-HD powder Replace cap securely on bottle and shake vigorously for 30 seconds Wait 5 minutes and re-shake bottle thoroughly. Reconstitution yields approximately 140 mL of E-Z-HD for oral suspension containing 2.38 grams of barium sulfate per mL 2.3 Administration Instructions Administer the reconstituted E-Z-HD for oral suspension immediately upon reconstitution To use with a straw, remove the adhesive label from top of the cap. Remove cap and use straw to push out cap liner. Replace cap Discard any unused suspension Advise patients to hydrate following the barium sulfate procedure

4 CONTRAINDICATIONS E-Z-HD is contraindicated in patients: Known or suspected perforation of the GI tract Known obstruction of the GI tract At 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 At high risk of aspiration such as those with prior aspiration, tracheo-esophageal fistula, or obtundation With known severe hypersensitivity to barium sulfate or any of the E-Z-HD excipients Known or suspected perforation of the GI tract ( 4 ) Conditions associated to high risk of aspiration ( 4 ) Conditions associated to high risk of GI perforation ( 4 ) Known hypersensitivity to barium sulfate or any of the excipients of E-Z-HD ( 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.

2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is E-Z-HD used for?
1 INDICATIONS AND USAGE E-Z-HD is indicated for use in double-contrast radiographic examinations of the esophagus, stomach and duodenum to help visualize the gastrointestinal (GI) tract in patients 12 years and older. E-Z-HD, a radiographic contrast agent, is indicated for use in double-contrast radiographic examinations of the esophagus, stomach and duodenum to visualize the gastrointestinal …

Who makes E-Z-HD?
E-Z-EM Canada Inc is the labeler of record for E-Z-HD. 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 E-Z-HD 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 E-Z-HD 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 E-Z-HD been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.