Instructions for Use
Lansoprazole (lan-SOH-pra zohl)
Delayed-Release Capsules, USP
• 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:
You can only use apple juice, orange juice or tomato juice.
1 Open the capsule.
2 Sprinkle the granules into 60 mL (about ¼ cup) of apple juice, orange juice or tomato juice.
4 Swallow right away.
5 To make sure that the entire dose is taken, add 1/2 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 and granule 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 Instructions for Use has been approved by the U.S. Food and Drug Administration.
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Hetero Labs Limited.
Quallent Pharmaceuticals Health LLC
20 Genesis Close
Grand Cayman KY1-1208
Hetero Labs Limited
Jeedimetla, Hyderabad — 500 055, India
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Lansoprazole Delayed-Release Capsules, USP 30 mg — 500s count
| LANSOPRAZOLE lansoprazole capsule, delayed release |
|Product Information |
|Product Type ||HUMAN PRESCRIPTION DRUG ||Item Code (Source) ||NDC:82009-039 |
|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 |
| POLYSORBATE 80 || |
| SUCROSE || |
| TALC || |
| TITANIUM DIOXIDE || |
| TRIETHYL CITRATE || |
| FD&C BLUE NO. 1 || |
| D&C RED NO. 28 || |
| FD&C RED NO. 40 || |
| SHELLAC || |
| GELATIN || |
| PROPYLENE GLYCOL || |
| SILICON DIOXIDE || |
| STARCH, CORN || |
| HYDROXYPROPYL CELLULOSE || |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED || |
| MAGNESIUM CARBONATE || |
| METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A || |
|Product Characteristics |
|Color ||pink, black ||Score ||no score |
|Shape ||CAPSULE ||Size ||19mm |
|Flavor || ||Imprint Code ||H;167 |
|Contains || |
|# ||Item Code ||Package Description ||Multilevel Packaging |
| 1 ||NDC:82009-039-05 ||500 CAPSULE, DELAYED RELEASE in 1 BOTTLE ||None |
| Marketing Information |
|Marketing Category ||Application Number or Monograph Citation ||Marketing Start Date ||Marketing End Date |
|ANDA ||ANDA203083 ||10/14/2022 || |
|Labeler — Quallent Pharmaceuticals Health LLC
| Establishment |
|Name ||Address ||ID/FEI ||Operations |
|Hetero Labs Limited Unit III || ||676162024 ||manufacture (82009-039) |
Revised: 10/2022 Quallent Pharmaceuticals Health LLC
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