Lansoprazole

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lansoprazole 15mg

Purpose

OTC - PURPOSE SECTION

Acid reducer

Uses

INDICATIONS & USAGE SECTION

● treats frequent heartburn (occurs 2 or more days a week)

● not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Warnings

WARNINGS SECTION

Allergy alert: Do not use if you are allergic to lansoprazole

Do Not Use

OTC - DO NOT USE SECTION

● if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.

Ask a Doctor before use if you have

OTC - ASK DOCTOR SECTION

● liver disease

● had heartburn over 3 months. This may be a sign of a more serious condition.

● heartburn with lightheadedness, sweating or dizziness

● chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness

● frequent chest pain

● frequent wheezing, particularly with heartburn

● unexplained weight loss

● nausea or vomiting

● stomach pain

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

• taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if

OTC - STOP USE SECTION

● your heartburn continues or worsens

● you need to take this product for more than 14 days

● you need to take more than 1 course of treatment every 4 months

● you get diarrhea

● you develop a rash or joint pain

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

● adults 18 years of age and older

● this product is to be used once a day (every 24 hours), every day for 14 days

● it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours

14-Day Course of Treatment

● swallow 1 capsule with a glass of water before eating in the morning

● take every day for 14 days

● do not take more than 1 capsule a day

● swallow whole. Do not crush or chew capsules.

● do not use for more than 14 days unless directed by your doctor

Repeated 14-Day Course of Treatment (if needed)

● you may repeat a 14-day course every 4 months

● do not take for more than 14 days or more often than every 4 months unless directed by a doctor

● children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.

Other Information

SPL UNCLASSIFIED SECTION

● read the directions, warnings and package insert before use

● keep the carton and package insert. They contain important information.

● store at 20-25°C (68-77°F)

● keep product out of high heat and humidity

● protect product from moisture

● close cap tightly after use

Inactive Ingredients

INACTIVE INGREDIENT SECTION

ammonium hydroxide, black iron oxide, butyl alcohol, dehydrated alcohol, FD&C Blue #1, FD&C Red #40, gelatin, hypromellose, iron oxide yellow, isopropyl alcohol, magnesium carbonate, mannitol, methacrylic acid and ethyl acrylate copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, sodium lauryl sulfate, sodium starch glycolate, sugar sphere, talc, titanium dioxide

Questions or Comments

OTC - QUESTIONS SECTION

1-844-834-0530

Distributed by:

Lannett Company, Inc.

Philadelphia, PA 19136

CIA79102B

Rev. 09/20

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

• Lansoprazole 24 HR
• Lansoprazole
• AMMONIA
• FERROSOFERRIC OXIDE
• BUTYL ALCOHOL
• ALCOHOL
• FD&C BLUE NO. 1
• FD&C RED NO. 40
• GELATIN
• HYPROMELLOSE 2910 (6 MPA.S)
• FERRIC OXIDE YELLOW
• ISOPROPYL ALCOHOL
• MAGNESIUM CARBONATE
• MANNITOL
• METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
• POLYETHYLENE GLYCOL 6000
• POLYSORBATE 80
• PROPYLENE GLYCOL
• SHELLAC
• SODIUM LAURYL SULFATE
• SODIUM STARCH GLYCOLATE TYPE A CORN
• SUCROSE
• TALC
• TITANIUM DIOXIDE

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Source Document#

Source XML

Orange Book application contexts#

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Observed Orange Book product history#

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Product history page 1 of 2 · 43 observed states.

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