Home › NDC Lookup › Ingredients › Barium Sulfate › 32909-0814-53
Tagitol V Barium Sulfate 400 mg/mL Suspension — NDC 32909-0814-53 package photo

Tagitol V Barium Sulfate 400 mg/mL Suspension

by E-Z-EM Canada Inc · 24 BOX in 1 CASE (32909-814-53) / 3 BOTTLE, PLASTIC in 1 BOX / 20 mL in 1 BOTTLE, PLASTIC
NDC 32909-0814-53
🏷️ FDA NDC (as labeled) 32909-814-53 billing pads the product segment with a zero
This package
Contains20 mL in 1 bottle, plastic Pack sizes2 compare ↓
Also comes in: 3 bottles 32909-0814-55
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 32909-814-53
Product NDC 32909-814
11-digit billing NDC 32909081453
NCPDP billing unit ML — per mL (volume)
UNII 25BB7EKE2E
Application # NDA208143
SPL Set ID 30c68756-c7db-bf50-9cd5-ef4b0c7ab1d0
Established class (EPC) Radiographic Contrast Agent
Mechanism of action X-Ray Contrast Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-08-04
Route ORAL
Dosage form SUSPENSION
Substance BARIUM SULFATE
GPI-14 94401010101834
GPI class Tagitol V
GCN Seq No 059660
GCN 25405
HICL code 001119
Ingredient (HICL) Barium Sulfate
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D0
Therapeutic class — intermediate (HIC2) Drugs Acting Primarily On The Gi Tract As A Whole
HIC3 code D0U
Therapeutic class — specific (HIC3) Gastrointestinal Radiopaque Diagnostics
AHFS code 36:68.00.00
AHFS class Roentgenography And Other Imaging Agents
FDB label name TAGITOL V 40% SUSPENSION
FDB brand name Tagitol V
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 32909-814-53 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 32909-0814-53. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerE-Z-EM Canada Inc
Application holderBRACCO DIAGNOSTICS INC
FDA applicationNDA208143 (NDA)
Labeler code32909
First marketedAug 2017
Product typeHuman Prescription Drug
Portfolio16 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name TAGITOL V 40% SUSPENSION Ingredient Barium Sulfate
📗 Our plain-language guide HelloPharmacist
  • Barium sulfate blocks X-rays, so when you drink it, it coats the inside of your esophagus, stomach, and intestines and makes them light up clearly on the scan or X-ray image. Witho...
  • Why do I have to drink barium before my scan? What does it actually do?
  • Your body doesn't absorb barium sulfate — it passes straight through your digestive tract and comes out in your stool, usually within a day or two. You may notice your stool looks...
  • Will it stay in my body? Is it safe to swallow?
📖 Read our full Barium Sulfate guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White
FlavorApple
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII MCU2324216
    A silicone-based oil that reduces foaming and helps ingredients mix evenly. It's used as an antifoaming agent and lubricant in tablets, capsules, and liquid formulations.
  • UNII 2Y53S6ATLU
    Dimethicone 350 is a silicone-based oil. It works as a lubricant and anti-foaming agent to help the medicine flow smoothly during manufacturing and reduce unwanted bubbles in the final product.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII B22547B95K
    A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
  • UNII VCQ006KQ1E
    Xylitol is a naturally occurring sugar alcohol derived from plants. It's used in medicines as a sweetener, bulking agent, and to improve taste, especially in liquid formulations and chewable tablets.

15 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 3 bottles
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Varibar Thin Honey 400 mg/mL 32909-0121-07 E-Z-EM 1 bottle — — FDA listed —
Varibar Honey 400 mg/mL 32909-0122-07 E-Z-EM 1 bottle — — FDA listed —
Tagitol V 400 mg/mLthis 32909-0814-53 E-Z-EM 3 bottles — — FDA listed —
Varibar Nectar 400 mg/mL 32909-0116-00 E-Z-EM 240 ml — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2017
On the market since
Aug 2017
📍
2026
Currently FDA-listed
9 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
32909-0814-53 You're viewing this 24 BOX in 1 CASE (32909-814-53) / 3 BOTTLE, PLASTIC in 1 BOX / 20 mL in 1 BOTTLE, PLASTIC 2017-08-04 Active
32909-0814-55 24 BOX in 1 CASE (32909-814-55) / 3 BOTTLE, GLASS in 1 BOX / 20 mL in 1 BOTTLE, GLASS 2022-10-01 Active

Pack size FAQ

What quantity is in NDC 32909-0814-53?
NDC 32909-0814-53 is listed by the FDA — 24 box in 1 case / 3 bottle, plastic in 1 box / 20 ml in 1 bottle, plastic.
What NDC number is used to bill for this package of Tagitol V Barium Sulfate 400 mg/mL Suspension?
Bill NDC 32909-0814-53 — the 11-digit billing format is 32909081453. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 32909-814-53, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 32909-0814-53, written without dashes as 32909081453. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 32909-0814-53, the first segment (32909) is the labeler code FDA assigned to E-Z-EM Canada Inc; the middle segment (0814) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (53) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by E-Z-EM Canada Inc. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 3 bottles (32909-0814-55). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
E-Z-EM Canada Inc is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 51 words ▾

1 INDICATIONS AND USAGE TAGITOL V is indicated for use in adult patients for use in computed tomography (CT) colonography as a fecal tagging agent. TAGITOL V is a radiographic contrast agent indicated in adult patients for use in computed tomography (CT) colonography as a fecal tagging agent ( 1 )

⏱️ Dosage and Administration 146 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dose is: One 20 mL bottle (8g barium sulfate) with each meal (breakfast, lunch and dinner) the day before the CT colonography examination ( 2.1 ). Total dose = 3 bottles (24 g barium sulfate) For oral use only ( 2.2 ).

2.1Recommended Dosing The recommended oral dose of TAGITOL V is one 20 mL bottle (8 g barium sulfate) with each meal (breakfast, lunch and dinner) the day before the colonography examination. Total dose = 3 bottles (24 g barium sulfate).

2.2Important Administration Instructions TAGITOL V is typically provided to the patient for self-administration. Advise patients to carefully read and follow the Patient Instructions for Use to be provided to the patient. Shake bottle for 15 seconds prior to administration. For oral use only. Encourage patients to hydrate following the barium sulfate procedure. Discard any unused suspension.

💊 Dosage Forms and Strengths 59 words ▾

3 DOSAGE FORMS AND STRENGTHS Oral suspension: barium sulfate (40% w/v) supplied as a ready-to-use suspension in a 20 mL, single-dose, bottle for oral administration. Each 20 mL bottle contains 8 g of barium sulfate. Oral suspension : barium sulfate (40% w/v) 20 mL single dose bottles as a ready to use suspension for oral administration ( 3 )

⛔ Contraindications 151 words ▾

4 CONTRAINDICATIONS TAGITOL V 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 prior aspiration, tracheo-esophageal fistula, or obtundation; - known hypersensitivity to barium sulfate or any of the excipients of TAGITOL V.

TAGITOL V is contraindicated in patients with: 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 TAGITOL V ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions: Emergency equipment and trained personnel should be immediately available ( 5.1 ) Intra-abdominal barium leakage: May occur in conditions which increase the risk of perforation such as - carcinoma, GI fistula, inflammatory bowel disease, gastric or duodenal ulcer, appendicitis, diverticulitis, or severe stenosis or obstructing lesions of the GI tract ( 5.2 ) Delayed GI transit and obstruction: Patients should maintain adequate hydration in days following a barium sulfate procedure to avoid obstruction or impaction by baroliths ( 5.3 ) Aspiration pneumonitis: Caution is recommended in patients with a history of food aspiration and in patients with known swallowing disorders ( 5.4 )

5.1Hypersensitivity Reactions Barium sulfate preparations contain a number of excipients, including natural and artificial flavors and may induce serious hypersensitivity reactions. The manifestations include hypotension, bronchospasm and other respiratory impairments, dermal reactions including rashes, urticaria and itching. A history of bronchial asthma, atopy, or a previous reaction to a contrast agent may increase the risk for hypersensitivity reactions.

Emergency equipment and trained personnel should be immediately available for treatment of a hypersensitivity reaction.

5.2Intra-abdominal Barium Leakage The use of TAGITOL V is contraindicated in patients at high risk of perforation of the GI tract [see Contraindications ( 4 )]. Administration of TAGITOL V may result in leakage of barium from the GI tract in the presence of conditions that increase the risk of perforation such as carcinomas, GI fistula, inflammatory bowel disease, gastric or duodenal ulcer, appendicitis, or diverticulitis, and in patients with a severe stenosis at any level of the gastrointestinal tract, especially if it is distal to the stomach.

The barium leakage has been associated with peritonitis and granuloma formation.

5.3Delayed Gastrointestinal Transit and Obstruction Orally administered barium sulfate may accumulate proximal to a constricting lesion of the colon, causing obstruction or impaction with development of baroliths (inspissated barium associated with feces) and may lead to abdominal pain, appendicitis, bowel obstruction, or rarely perforation. Patients with the following conditions are at higher risk for developing obstruction or baroliths: severe stenosis at any level of the GI tract, impaired gastrointestinal motility, electrolyte imbalance, dehydration, on a low residue diet, on medications that delay GI motility, constipation, cystic fibrosis, Hirschsprung disease, and the elderly.

To reduce the risk of delayed GI transit and obstruction, patients should maintain adequate hydration following a barium sulfate procedure.

5.4Aspiration Pneumonitis The use of TAGITOL V is contraindicated in patients at high risk of aspiration [see Contraindications ( 4 )]. Oral administration of barium is associated with aspiration pneumonitis, especially in patients with a history of food aspiration or with compromised swallowing mechanism. Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis.

5.5Systemic Embolization Barium sulfate products may occasionally intravasate into the venous drainage of the large bowel and enter the circulation as a "barium embolus" leading to potentially fatal complications which include systemic and pulmonary embolism, disseminated intravascular coagulation, septicemia and prolonged severe hypotension. Although this complication is exceedingly uncommon after oral administration of barium sulfate products, monitor patients for potential intravasation when administering barium sulfate.

🤒 Adverse Reactions 111 words ▾

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

👥 Use in Specific Populations 171 words ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary TAGITOL V 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 )] .

8.2Lactation Risk Summary TAGITOL V is not absorbed systemically by the mother following oral administration and breastfeeding is not expected to result in exposure of the infant to the drug [see Clinical Pharmacology ( 12.3 )]

8.4Pediatric Use TAGITOL V is not indicated for pediatric use.

8.5Geriatric Use Clinical studies of TAGITOL V do not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences 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 the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🤰 Pregnancy 34 words ▾

8.1Pregnancy Risk Summary TAGITOL V 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 )] .

🧒 Pediatric Use 11 words ▾

8.4Pediatric Use TAGITOL V is not indicated for pediatric use.

🧓 Geriatric Use 84 words ▾

8.5Geriatric Use Clinical studies of TAGITOL V do not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences 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 the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🧬 Clinical Pharmacology 72 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Due to its high atomic number, barium (the active ingredient in TAGITOL V) is opaque to x-rays and therefore acts as a positive contrast agent for radiographic studies.

12.2Pharmacodynamics Barium sulfate is biologically inert and has no known pharmacological effects.

12.3Pharmacokinetics Under physiological conditions, barium sulfate passes through the gastrointestinal tract in an unchanged form and is absorbed only in pharmacologically insignificant amounts.

🧬 Mechanism of Action 32 words ▾

12.1Mechanism of Action Due to its high atomic number, barium (the active ingredient in TAGITOL V) is opaque to x-rays and therefore acts as a positive contrast agent for radiographic studies.

📦 How Supplied / Storage and Handling 68 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied TAGITOL V (barium sulfate) is an oral suspension (40% w/v) supplied as a box of three 20 mL bottles. Each bottle contains 8 grams barium sulfate. Provided as: 24 boxes, each containing 3 (20 mL) bottles (NDC 32909-814)

16.2Storage and Handling Store at room temperature 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do Not Freeze.

📋 Description 91 words ▾

11 DESCRIPTION TAGITOL V (barium sulfate) is a radiographic contrast agent that is supplied as a 40% w/v, off-white to lightly colored, free-flowing, ready-to-use suspension with an apple aroma for oral administration. The active ingredient barium sulfate is designated chemically as BaSO 4 with a molecular weight of 233.4 g/mol and the following chemical structure: TAGITOL V 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

💬 Information for Patients 135 words ▾

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 )] .

Administration Instructions TAGITOL V is typically provided to the patient for self-administration. Advise patients to carefully read and follow the Patient Instructions for Use to be provided to the patient. Provide the patient with any site specific instructions regarding their procedure and when to take meals.

Rx only Manufactured by EZEM Canada Inc Anjou (Quebec) Canada H1J 2Z4 For Bracco Diagnostics Inc. Princeton, NJ 08540 rev. 02/2025

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 32909-0770-01 · E-Z-EM 32995-3601-01 · Vistin →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.