Varibar Thin Honey (Page 2 of 2)

11  DESCRIPTION

VARIBAR THIN HONEY (barium sulfate) is a radiographic contrast agent that is supplied as an off-white to lightly colored suspension (40% w/v) with an apple aroma for oral administration. The active ingredient barium sulfate is designated chemically as BaSO₄ with a molecular weight of 233.4 g/mol, a density of 4.5 g/cm³ , and the following chemical structure:

VARIBAR THIN HONEY has a viscosity of 1500 cPs and contains the following excipients:
carboxymethylcellulose sodium, citric acid, glycerin, natural and artificial apple flavor, polysorbate 80, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, starch modified (from corn), xanthan gum, and xylitol.

12  CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Due to its high atomic number, barium (the active ingredient in VARIBAR THIN HONEY) is opaque to x-rays and therefore acts as a positive contrast agent for radiographic studies.

12.2 Pharmacodynamics

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

12.3 Pharmacokinetics

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

13  NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No animal studies have been performed to evaluate the carcinogenic potential of barium sulfate or potential effects on fertility.

16  HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

VARIBAR THIN HONEY is supplied as a suspension in a multiple-dose polyethylene bottle containing 250 mL of barium sulfate (40 % w/v).

Provided as: 12 x 250 mL bottles (NDC 32909-121-07)

16.2 Storage and Handling

Store at USP controlled room temperature 20 to 25°C (68 to 77° F). Protect from freezing.

Once opened, VARIBAR THIN HONEY may be used for up to 21 days when stored at USP controlled room temperature, 20 to 25°C (68 to 77° F).

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)].

Rx only

Manufactured by
EZEM Canada Inc
Anjou (Quebec) Canada H1J 2Z4

For
Bracco Diagnostics Inc.
Monroe Township, NJ 08831

VARIBAR is a registered trademark of E-Z-EM, Inc.

January 2018

Varibar Thin Honey Box

Varibar Thin Honey Unit Label

VARIBAR THIN HONEY barium sulfate suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:32909-121 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Barium Sulfate (Barium Sulfate) Barium Sulfate 400 mg in 1 mL

Inactive Ingredients Ingredient Name Strength anhydrous citric acid carboxymethylcellulose sodium dimethicone 350 dimethicone 1000 glycerin modified corn starch (1-octenyl succinic anhydride) polysorbate 80 potassium sorbate silicon dioxide sodium benzoate trisodium citrate dihydrate water xanthan gum xylitol saccharin sodium

Product Characteristics Color WHITE Score Shape Size Flavor APPLE Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:32909-121-07 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC 1 250 mL in 1 BOTTLE, PLASTIC This package is contained within the BOX (32909-121-07)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208143 01/03/2018

Labeler — E-Z-EM Canada Inc (204211163)

Registrant — E-Z-EM, INC. (002041226)

Establishment
Name	Address	ID/FEI	Operations
E-Z-EM Canada Inc		204211163	MANUFACTURE (32909-121), LABEL (32909-121), ANALYSIS (32909-121), PACK (32909-121)

Revised: 11/2018 E-Z-EM Canada Inc