Protonix Delayed-Release (Page 10 of 10)

Instructions for Use PROTONIX (pro-TAH-nix) (pantoprazole sodium) for delayed-release oral suspension

PROTONIX for delayed-release oral suspension (PROTONIX for oral suspension) :

Important information:

  • Do not split, chew, or crush PROTONIX for oral suspension.
  • Take PROTONIX for oral suspension about 30 minutes before a meal.
  • PROTONIX for 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 PROTONIX for oral suspension with applesauce:
    1. Open the packet of PROTONIX for 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 PROTONIX for oral suspension with apple juice:
    1. Open the packet of PROTONIX for 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 PROTONIX for oral suspension through a nasogastric (NG) tube or gastrostomy tube:
    • PROTONIX for oral suspension may be given through an NG tube or gastrostomy tube that is size 16 French or larger. Do not give PROTONIX for oral suspension through an NG tube or gastrostomy tube smaller than size 16 French.
    • Mix PROTONIX for 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 PROTONIX for oral suspension to prevent the tubing from bending.
      4. Open the packet of PROTONIX for 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 PROTONIX?

Store PROTONIX at room temperature between 68°F to 77°F (20°C to 25°C).

Keep PROTONIX and all medicines out of the reach of children.

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

This product’s label may have been updated. For current full prescribing information, please go to www.pfizer.com.

Pfizer Logo
(click image for full-size original)

under license from
Takeda GmbH
D78467 Konstanz, Germany

LAB-0574-15.0

Revised: November 2020

PRINCIPAL DISPLAY PANEL — 20 mg Tablet Bottle Label

ALWAYS DISPENSE WITH
MEDICATION GUIDE

Pfizer
NDC 0008-0843-81

Protonix ®
(pantoprazole sodium)
delayed-release tablets

20 mg

Swallow tablets whole. Do NOT
split, chew, or crush tablets.

90 Tablets Rx only

Principal Display Panel -- 20 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 40 mg Tablet Bottle Label

ALWAYS DISPENSE WITH MEDICATION GUIDE

Pfizer
NDC 0008-0841-81

Protonix ®
(pantoprazole sodium)
delayed-release tablets

40 mg

Swallow tablets whole. Do NOT
split, chew, or crush tablets.

90 Tablets Rx only

Principal Display Panel -- 40 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 40 mg Packet

NDC 0008-0844-01

Pfizer

Protonix ®
40 mg
(pantoprazole sodium)

For Delayed-Release Oral Suspension*
*suspension in apple juice or applesauce only

Each packet contains:
Pantoprazole
40 mg
(equivalent to 45.1 mg of pantoprazole sodium)

14287101
F.2/0518/6103546 Code 40

Rx only

Principal Display Panel -- 40 mg Packet
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 40 mg Packet Carton

Pfizer

NDC 0008-0844-02

ALWAYS DISPENSE WITH MEDICATION GUIDE

Protonix ®
40 mg
(pantoprazole sodium)

For Delayed-Release Oral Suspension*
*suspension in apple juice or applesauce only

Rx only 30 Packets

Principal Display Panel -- 40 mg Packet Carton
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REDPHARM
(click image for full-size original)

PROTONIX DELAYED-RELEASE pantoprazole sodium tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67296-0029(NDC:0008-0841)
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
CALCIUM STEARATE
CROSPOVIDONE (120 .MU.M)
MANNITOL
FERRIC OXIDE YELLOW
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYSORBATE 80
POVIDONE K25
POVIDONE K90
PROPYLENE GLYCOL
SODIUM CARBONATE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIETHYL CITRATE
HYPROMELLOSE 2910 (6 MPA.S)
Product Characteristics
Color yellow (YELLOW) Score no score
Shape OVAL (BICONVEX) Size 12mm
Flavor Imprint Code PROTONIX
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67296-0029-7 14 TABLET, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020987 05/01/2000
Labeler — RedPharm Drug, Inc. (828374897)
Establishment
Name Address ID/FEI Operations
EPM Packaging, Inc. 079124340 repack (67296-0029)

Revised: 01/2022 RedPharm Drug, Inc.

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