PANTOPRAZOLE SODIUM: Package Insert and Label Information (Page 6 of 6)

INSTRUCTIONS FOR USE

Pantoprazole Sodium (pan-TOE-pra-zole SOE-dee-um)

for Delayed-Release Oral Suspension

Important information:

• Do not split, chew, or crush pantoprazole sodium for delayed-release oral suspension.
• Take pantoprazole sodium for delayed-release oral suspension about 30 minutes before a meal.
  • Pantoprazole sodium for delayed-release oral suspension:
    • should only be taken with applesauce or apple juice.
    • should not be mixed in water or other liquids, or other foods.
    • packet should not be divided to make a smaller dose.

Taking pantoprazole sodium for delayed-release oral suspension with applesauce:

1. Open the packet of pantoprazole sodium for delayed-release oral suspension.
2. Sprinkle all of the granules in the packet on 1 teaspoon of applesauce.
3. Swallow the granules and applesauce within 10 minutes of putting the granules on the teaspoon of applesauce.
4. Take sips of water to make sure the granules are washed down into the stomach. Take more sips of water as needed.

Taking pantoprazole sodium for delayed-release oral suspension with apple juice:

1. Open the packet of pantoprazole sodium for delayed-release oral suspension.
2. Empty all of the granules in the packet into a small cup that contains 1 teaspoon of apple juice.
3. Stir the granules-apple juice mixture for 5 seconds. The granules will not break up.
4. Swallow the mixture right away.
5. To make sure that the entire dose is taken, add more apple juice to the cup, stir and swallow the apple juice right away.
6. Repeat step 5 if there are granules left in the cup.

Giving pantoprazole sodium for delayed-release oral suspension through a nasogastric (NG) tube or gastrostomy tube:

• Pantoprazole sodium for delayed-release oral suspension may be given through an NG tube or gastrostomy tube that is size 16 French or larger. Do not give pantoprazole sodium for delayed-release oral suspension through an NG tube or gastrostomy tube smaller than size 16 French.
• Mix pantoprazole sodium for delayed-release oral suspension only in apple juice when giving through an NG tube or gastrostomy tube.

1. Remove the plunger from a 60 mL (2 ounce) catheter-tip syringe. Throw away the plunger.
2. Connect the tip of the catheter-tip syringe to the NG tube or gastrostomy tube.
3. Hold the syringe attached to the NG tube or gastrostomy tube as high as possible while giving pantoprazole sodium for delayed-release oral suspension to prevent the tubing from bending.
4. Open the packet of pantoprazole sodium for delayed-release oral suspension.
5. Empty all the granules in the packet into the catheter-tip syringe.
6. Add 10 mL (2 teaspoons) of apple juice into the catheter-tip syringe and gently tap or shake the syringe to help empty the syringe.
7. Repeat step 6 at least 2 more times until there are no granules left in the catheter-tip syringe.

How should I store pantoprazole sodium for delayed-release oral suspension?
Pantoprazole sodium for delayed-release oral suspension comes in a child-resistant package.
Store pantoprazole sodium for delayed-release oral suspension at room temperature between 68°F to 77°F (20°C to 25°C).
Keep pantoprazole sodium for delayed-release oral suspension and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

* All trademark names are the property of their respective owners.
Dispense with Medication Guide available at: https://www.sunpharma.com/usa/products
Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512
Manufactured by:

Sun Pharmaceutical Industries Limited

Mohali, India.

Revised: 08/2022

PRINCIPAL DISPLAY PANEL — PACKET

NDC 62756-071-60
Pantoprazole Sodium for Delayed-Release Oral Suspension*
40 mg
*suspension in apple juice or applesauce only

Each packet contains 40 mg pantoprazole equivalent to 45.1 mg of pantoprazole sodium USP (sesquihydrate)
Store at 20° to 25°C (68° to 77°F).
Rx only SUN PHARMA

PRINCIPAL DISPLAY PANEL — CARTON

NDC 62756- 071 -64
Pantoprazole Sodium for Delayed-Release Oral Suspension*
40 mg
*suspension in apple juice or applesauce only
PHARMACIST: Dispense with Medication Guide to each patient.
Rx only
30 Packets
SUN PHARMA

PANTOPRAZOLE SODIUM pantoprazole sodium granule, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62756-071 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PANTOPRAZOLE SODIUM (PANTOPRAZOLE) PANTOPRAZOLE 40 mg

Inactive Ingredients Ingredient Name Strength SODIUM CARBONATE CROSPOVIDONE (120 .MU.M) POVIDONE K30 CALCIUM STEARATE HYPROMELLOSE 2910 (5 MPA.S) TALC METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER TRIETHYL CITRATE TITANIUM DIOXIDE FERRIC OXIDE YELLOW HYDROXYPROPYL CELLULOSE (110000 WAMW) MICROCRYSTALLINE CELLULOSE 101 POLYSORBATE 80 SODIUM LAURYL SULFATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62756-071-64 30 PACKET in 1 CARTON contains a PACKET (62756-071-60) 1 NDC:62756-071-60 1 GRANULE, DELAYED RELEASE in 1 PACKET This package is contained within the CARTON (62756-071-64)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA213725 07/01/2020

Labeler — Sun Pharmaceutical Industries, Inc. (146974886)

Establishment
Name	Address	ID/FEI	Operations
Sun Pharmaceutical Industries Limited		650456002	ANALYSIS (62756-071), MANUFACTURE (62756-071)

Revised: 08/2022 Sun Pharmaceutical Industries, Inc.