Lansoprazole (Page 12 of 12)

INSTRUCTIONS FOR USE

Lansoprazole (lan soe’ pra zole) Delayed-Release Capsules, for oral use

Important

  • Take lansoprazole delayed release capsules before meals.
  • Do not crush or chew lansoprazole delayed release capsules.
  • Lansoprazole delayed release capsules should only be used with the foods and juices listed below.

Lansoprazole Delayed-Release Capsules

Taking lansoprazole delayed release capsules with certain foods:

You can only use applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.

1. Open the capsule.

2. Sprinkle the granules on 1 tablespoon of applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.

3. Swallow right away.

Taking lansoprazole delayed release capsules with certain juices:

1. Open the capsule.

2. Sprinkle the granules into 60 mL (about ¼ cup) of apple juice, orange juice or tomato juice.

3. Stir.

4. Swallow right away.

5. To make sure that the entire dose is taken, add ½ cup or more of juice to the glass, stir and swallow right away.

Giving lansoprazole delayed release capsules through a nasogastric tube (NG tube) size 16 French or larger:

You can only use apple juice.

1.Place 40 mL of apple juice into a clean container

2.Open the capsule and empty the granules into the container of apple juice.

3.Use a catheter-tip syringe to draw up the apple juice and granule mixture.

4.Gently mix the catheter-tip syringe to keep the granules from settling.

5.Attach the catheter-tip syringe to the NG tube.

6.Give the mixture right away through the NG tube that goes into the stomach. Do not save the apple juice andgranule mixture for later use.

7.Refill the catheter-tip syringe with 40 mL of apple juice and mix gently. Flush the NG tube with apple juice.

How should I store lansoprazole delayed-release capsules?

  • Store lansoprazole delayed-release capsules at room temperature between 68°F to 77°F (20°C to 25°C).

Keep lansoprazole delayed-release capsules and all medicines out of the reach of children.

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

All trademark names are the property of their respective owners.

Manufactured for:
Xiromed LLC
Florham Park, NJ 07932

Made in Spain

Marketed/Packaged by:

GSMS, Inc.

Camrillio, CA 93012 USA

R04/2022

PI263-11

Package/Label Display Panel

NDC 51407-324-01
Lansoprazole
Delayed-Release Capsules, USP
30 mg 100 count

//medlibrary.org/lib/images-rx/lansoprazole-41/51407-324-01-rev-08-22-300x123.jpg
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LANSOPRAZOLE lansoprazole capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-324(NDC:70700-263)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LANSOPRAZOLE (LANSOPRAZOLE) LANSOPRAZOLE 30 mg
Inactive Ingredients
Ingredient Name Strength
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
HYPROMELLOSES
MAGNESIUM CARBONATE
MANNITOL
POLYSORBATE 20
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SUCROSE
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 2
GELATIN
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
BUTYL ALCOHOL
ISOPROPYL ALCOHOL
SHELLAC
Product Characteristics
Color white (white body/light blue cap) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 30mg;A263
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-324-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203203 07/25/2016
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 relabel (51407-324), repack (51407-324)

Revised: 09/2022 Golden State Medical Supply, Inc.

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