Lansoprazole: Package Insert and Label Information (Page 11 of 11)

PRINCIPAL DISPLAY PANEL – 15 mg

NDC 0378-6981-88

Lansoprazole
Delayed-Release Orally Disintegrating
Tablets
15 mg

Phenylketonurics: Contains phenylalanine (a component of aspartame) 3.37 mg per tablet.

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Rx only 100 Unit-Dose Tablets (10 Cards x 10 Tablets)

Each tablet contains 15 mg of lansoprazole, USP as enteric-coated pellets.

Usual Dosage: See accompanying prescribing information.

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room Temperature.]

Medication Guides may be obtained at Mylan.com/MedCenter or call 1-888-839-8993.

Keep this and all medication out of the reach of children.

Do not use if blisters are torn, broken or missing.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Code No.: MH/DRUGS/25/NKD/89

Mylan.com

MX:6981:100C:R5

PHARMACIST INSTRUCTIONS FOR THE PATIENT

Please inform patients of the following instructions for product use:

Lansoprazole delayed-release orally disintegrating tablets should not be chewed.

Lansoprazole delayed-release orally disintegrating tablets should be taken before eating.

Place the tablet on the tongue and allow it to disintegrate, with or without water, until the pellets can be swallowed.

Alternatively for children or other patients who have difficulty swallowing tablets, lansoprazole delayed-release orally disintegrating tablets can be delivered via oral syringe.

•

Place a 15 mg tablet in oral syringe and draw up approximately 4 mL of water.

•

Shake gently to allow for a quick dispersal.

•

After the tablet has dispersed, administer the contents within 15 minutes.

•

Refill the syringe with approximately 2 mL of water, shake gently and administer any remaining contents.

See accompanying prescribing information for nasogastric tube administration.

BLISTER OPENING INSTRUCTIONS

1.

Do not press blister pocket to open.

2.

Tear along the perforations to separate andremove one blister from the strip.

3.

Detach the triangular notch from the blister.

4.

Tear or Cut at notch to access the tablet.

5.

Remove the tablet from the opened blister.

PRINCIPAL DISPLAY PANEL – 30 mg

NDC 0378-6982-88

Lansoprazole
Delayed-Release Orally Disintegrating
Tablets
30 mg

Phenylketonurics: Contains phenylalanine (a component of aspartame) 6.74 mg per tablet.

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Rx only 100 Unit-Dose Tablets (10 Cards x 10 Tablets)

Each tablet contains 30 mg of lansoprazole, USP as enteric-coated pellets.

Usual Dosage: See accompanying prescribing information.

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room Temperature.]

Medication Guides may be obtained at Mylan.com/MedCenter or call 1-888-839-8993.

Keep this and all medication out of the reach of children.

Do not use if blisters are torn, broken or missing.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Code No.: MH/DRUGS/25/NKD/89

Mylan.com

MX:6982:100C:R5

PHARMACIST INSTRUCTIONS FOR THE PATIENT

Please inform patients of the following instructions for product use:

Lansoprazole delayed-release orally disintegrating tablets should not be chewed.

Lansoprazole delayed-release orally disintegrating tablets should be taken before eating.

Place the tablet on the tongue and allow it to disintegrate, with or without water, until the pellets can be swallowed.

Alternatively for children or other patients who have difficulty swallowing tablets, lansoprazole delayed-release orally disintegrating tablets can be delivered via oral syringe.

•

Place a 30 mg tablet in oral syringe and draw up approximately 10 mL of water.

•

Shake gently to allow for a quick dispersal.

•

After the tablet has dispersed, administer the contents within 15 minutes.

•

Refill the syringe with approximately 5 mL of water, shake gently and administer any remaining contents.

See accompanying prescribing information for nasogastric tube administration.

BLISTER OPENING INSTRUCTIONS

1.

Do not press blister pocket to open.

2.

Tear along the perforations to separate andremove one blister from the strip.

3.

Detach the triangular notch from the blister.

4.

Tear or Cut at notch to access the tablet.

5.

Remove the tablet from the opened blister.

LANSOPRAZOLE lansoprazole tablet, orally disintegrating, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-6981 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LANSOPRAZOLE (LANSOPRAZOLE) LANSOPRAZOLE 15 mg

Inactive Ingredients Ingredient Name Strength ASPARTAME CITRIC ACID MONOHYDRATE CROSPOVIDONE HYDROXYPROPYL CELLULOSE, UNSPECIFIED MAGNESIUM CARBONATE MAGNESIUM STEARATE MANNITOL METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 SODIUM BICARBONATE SODIUM HYDROXIDE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TRIETHYL CITRATE FERRIC OXIDE YELLOW STARCH, CORN SUCROSE

Product Characteristics Color YELLOW (pale yellow speckled) Score no score Shape ROUND Size 11mm Flavor STRAWBERRY Imprint Code M;LP1 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0378-6981-88 2 CARTON in 1 BOX contains a CARTON (0378-6981-85) 1 NDC:0378-6981-85 5 BLISTER PACK in 1 CARTON This package is contained within the BOX (0378-6981-88) and contains a BLISTER PACK (0378-6981-32) 1 NDC:0378-6981-32 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK This package is contained within a CARTON (0378-6981-85) and a BOX (0378-6981-88)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202396 11/29/2018

LANSOPRAZOLE lansoprazole tablet, orally disintegrating, delayed release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-6982 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 ASPARTAME CITRIC ACID MONOHYDRATE CROSPOVIDONE HYDROXYPROPYL CELLULOSE, UNSPECIFIED MAGNESIUM CARBONATE MAGNESIUM STEARATE MANNITOL METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 SODIUM BICARBONATE SODIUM HYDROXIDE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TRIETHYL CITRATE FERRIC OXIDE YELLOW STARCH, CORN SUCROSE

Product Characteristics Color YELLOW (pale yellow speckled) Score no score Shape ROUND Size 13mm Flavor STRAWBERRY Imprint Code M;LP2 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0378-6982-88 2 CARTON in 1 BOX contains a CARTON (0378-6982-85) 1 NDC:0378-6982-85 5 BLISTER PACK in 1 CARTON This package is contained within the BOX (0378-6982-88) and contains a BLISTER PACK (0378-6982-32) 1 NDC:0378-6982-32 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK This package is contained within a CARTON (0378-6982-85) and a BOX (0378-6982-88)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202396 11/29/2018

Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 04/2022 Mylan Pharmaceuticals Inc.