ZEGERID: Package Insert and Label Information (Page 8 of 8)

INSTRUCTIONS FOR USE

ZEGERID^® (ze-ger-id)

(omeprazole and sodium bicarbonate)

for oral suspension

Taking ZEGERID for oral suspension:

Important: ZEGERID should be taken on an empty stomach at least 1 hour before a meal.

1.

ZEGERID comes in packets containing 20 mg or 40 mg of ZEGERID.

2.

Use an oral syringe to draw up the amount of water needed to mix your dose. Ask your pharmacist for an oral syringe.

3.

Using the oral syringe, draw up 5 mL to 10 mL of water and add the water to a small cup. Do not mix ZEGERID with foods or liquids other than water.

4.

Empty the contents of the packet into the small cup.

5.

Stir well to dissolve the powder and drink the mixture right away.

6.

If any medicine remains after drinking, add more water, stir, and drink right away.

Giving ZEGERID for oral suspension with water through a nasogastric (NG) tube or orogastric (OG) tube:

Important: For patients receiving ZEGERID through a NG tube or OG tube, enteral feeding should be stopped approximately 3 hours before giving ZEGERID. You should wait at least 1 hour after giving ZEGERID before you start enteral feeding again.

1.

ZEGERID comes in packets containing 20 mg or 40 mg of ZEGERID.

2.

You will mix ZEGERID with 20 mL of water in a catheter tipped syringe.

3.

Use only a catheter tipped syringe to give ZEGERID through the NG or OG tube. Talk to your doctor about the size catheter tipped syringe you should use.

4.

Add 20 mL of water to the catheter tipped syringe. Do not use any food or liquids other than water to mix ZEGERID.

5.

Add the contents of 1 packet of ZEGERID to the syringe.

6.

Shake the syringe well to dissolve the powder.

7.

Inject the medicine through the NG or OG tube into the stomach right away.

8.

Refill the syringe with the same amount of water (20 mL) you used to prepare your dose of ZEGERID.

9.

Shake the syringe and flush any remaining medicine from the NG tube or OG tube into the stomach.

Distributed by:
Salix Pharmaceuticals, a division of
Bausch Health US, LLC
Bridgewater, NJ 08807 USAZEGERID is a trademark of Salix Pharmaceuticals, Inc. or its affiliates.

Any other product/brand names are trademarks of the respective owners.

© 2022 Salix Pharmaceuticals, Inc. or its affiliates

9658603 Revised: 03/2022

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL– 20mg sachet

NDC 68012-052-30

RX Only

Zegerid®

(omeprazole/sodium bicarbonate)

For Oral Suspension

Contains 30 single

20-mg dose packets

20 mg/1,680 mg

PHARMACIST: Dispense the enclosed

Medication Guide to each patient.

For more information, call 1-800-321-4576.

Salix PHARMACEUTICALS

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL- 40 mg sachet

NDC 68012-054-30

RX Only

Zegerid®

(omeprazole/sodium bicarbonate)

For Oral Suspension

Contains 30 single

40-mg dose packets

40 mg/1,680 mg

PHARMACIST: Dispense the enclosed

Medication Guide to each patient.

For more information, call 1-800-321-4576.

Salix PHARMACEUTICALS

Package/Label Display Panel — 20 mg capsules

Rx only

NDC 68012-102-30

Zegerid®

(omeprazole/sodium bicarbonate)

Capsules

30 Capsules

20mg/1100mg

PHARMACIST: Dispense the enclosed

Medication Guide to each patient.

Package/Label Display Panel – 40 mg capsules

NDC 68012-104-30

Rx only

Zegerid®

(omeprazole/sodium bicarbonate)

Capsules

30 Capsules

40mg/1100mg

PHARMACIST: Dispense the enclosed

Medication Guide to each patient.

ZEGERID omeprazole and sodium bicarbonate powder, for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68012-052 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE (OMEPRAZOLE) OMEPRAZOLE 20 mg SODIUM BICARBONATE (BICARBONATE ION) SODIUM BICARBONATE 1680 mg

Inactive Ingredients Ingredient Name Strength XYLITOL SUCROSE SUCRALOSE XANTHAN GUM

Product Characteristics Color Score Shape Size Flavor PEACH, PEPPERMINT Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68012-052-30 30 PACKET in 1 CARTON contains a PACKET 1 1 POWDER, FOR SUSPENSION in 1 PACKET This package is contained within the CARTON (68012-052-30)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021636 06/15/2004

ZEGERID omeprazole and sodium bicarbonate powder, for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68012-054 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE (OMEPRAZOLE) OMEPRAZOLE 40 mg SODIUM BICARBONATE (BICARBONATE ION) SODIUM BICARBONATE 1680 mg

Inactive Ingredients Ingredient Name Strength XYLITOL SUCROSE SUCRALOSE XANTHAN GUM

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68012-054-30 30 PACKET in 1 CARTON contains a PACKET 1 1 POWDER, FOR SUSPENSION in 1 PACKET This package is contained within the CARTON (68012-054-30) 2 NDC:68012-054-03 3 PACKET in 1 CARTON contains a PACKET 2 1 POWDER, FOR SUSPENSION in 1 PACKET This package is contained within the CARTON (68012-054-03)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021636 06/15/2014

ZEGERID omeprazole and sodium bicarbonate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68012-102 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE (OMEPRAZOLE) OMEPRAZOLE 20 mg SODIUM BICARBONATE (BICARBONATE ION) SODIUM BICARBONATE 1100 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM SODIUM STEARYL FUMARATE

Product Characteristics Color WHITE Score no score Shape CAPSULE Size 23mm Flavor Imprint Code 20 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68012-102-30 30 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021849 02/27/2006

ZEGERID omeprazole and sodium bicarbonate capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68012-104 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE (OMEPRAZOLE) OMEPRAZOLE 40 mg SODIUM BICARBONATE (BICARBONATE ION) SODIUM BICARBONATE 1100 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM SODIUM STEARYL FUMARATE

Product Characteristics Color BLUE, WHITE Score no score Shape CAPSULE Size 23mm Flavor Imprint Code 40 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68012-104-30 30 CAPSULE in 1 BOTTLE None 2 NDC:68012-104-05 5 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021849 02/27/2006

Labeler — Santarus, Inc.. (104286369)

Registrant — Salix Pharmaceuticals, Inc. (793108036)

Establishment
Name	Address	ID/FEI	Operations
Norwich Pharmaceuticals, Inc.		132218731	MANUFACTURE (68012-102), MANUFACTURE (68012-104)

Establishment
Name	Address	ID/FEI	Operations
Patheon Inc.		205475333	MANUFACTURE (68012-052), MANUFACTURE (68012-054), PACK (68012-052), PACK (68012-054)

Establishment
Name	Address	ID/FEI	Operations
UNION QUIMICO FARMACEUTICA SA		460940870	API MANUFACTURE (68012-052), API MANUFACTURE (68012-054), API MANUFACTURE (68012-102), API MANUFACTURE (68012-104)

Establishment
Name	Address	ID/FEI	Operations
Carton Service Incorporated		928861723	PACK (68012-052), PACK (68012-054), PACK (68012-102), PACK (68012-104)

Establishment
Name	Address	ID/FEI	Operations
PTI Royston LLC		601006997	MANUFACTURE (68012-054), MANUFACTURE (68012-102)

Establishment
Name	Address	ID/FEI	Operations
Bausch Health US, Inc.		253292734	MANUFACTURE (68012-052), MANUFACTURE (68012-054), MANUFACTURE (68012-102), MANUFACTURE (68012-104), PACK (68012-052), PACK (68012-054), PACK (68012-102), PACK (68012-104)

Revised: 03/2022 Santarus, Inc..