Perrigo Lansoprazole Drug Facts

Perrigo Lansoprazole Drug Facts
SPL v3
SPL
SPL Set ID 91d69826-df5c-47a2-b852-3083629d1893
Route
ORAL
Published
Effective Date 2024-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lansoprazole (15 mg)
Inactive Ingredients
D&c Red No. 28 D&c Yellow No. 10 Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin, Unspecified Hypromellose, Unspecified Low-substituted Hydroxypropyl Cellulose, Unspecified Mannitol Meglumine Methacrylic Acid And Ethyl Acrylate Copolymer Polyethylene Glycol, Unspecified Polysorbate 80 Sodium Lauryl Sulfate Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 24HR Shape: capsule Color: pink Color: green Size: 15 mm Score: 1
Marketing Status
ANDA Active Since 2021-11-22

Description

Lansoprazole 15 mg

Purpose

Acid Reducer


Medication Information

Purpose

Acid Reducer

Description

Lansoprazole 15 mg

Use
  • 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

Allergy alert:

  • do not use if you are allergic to lansoprazole
  • lansoprazole may cause severe skin reactions.

Symptoms may include:

  • skin reddening
  • blisters
  • rash

If an allergic reaction occurs, stop use and seek medical help right away.

Directions
  • 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 Courses (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
  • read the directions and warnings before use
  • keep the carton. It contains 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

D&C red no. 28, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, gelatin, hypromellose, low substituted hydroxypropyl cellulose, mannitol, meglumine, methacrylic acid copolymer, pharmaceutical ink, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide

Questions Or Comments?

1-800-719-9260

Do Not Use If You Have:
  • trouble or pain swallowing food, vomiting with blood, or bloody or black stools
  • 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

These may be signs of a serious condition. See your doctor.

Stop Use and Ask A Doctor If
  • 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,

ask a health care professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Active Ingredient (in Each Capsule)

Lansoprazole 15 mg

Ask A Doctor Before Use If You Have
  • liver disease
  • had heartburn over 3 months. This may be a sign of a more serious condition.
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
Package/label Principal Display Panel

GOODSENSE®

Treats Frequent Heartburn

Lansoprazole Delayed-Release Capsules 15 mg

Actual Size

Acid Reducer

24HR

• May take 1 to 4 days for full effect

• Sodium Free

Compare to active ingredient of Prevacid® 24 HR

28 Capsules

Two 14-Day Courses of Treatment

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Structured Label Content

Use
  • 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
Purpose

Acid Reducer

Warnings

Allergy alert:

  • do not use if you are allergic to lansoprazole
  • lansoprazole may cause severe skin reactions.

Symptoms may include:

  • skin reddening
  • blisters
  • rash

If an allergic reaction occurs, stop use and seek medical help right away.

Directions
  • 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 Courses (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 (Other information)
  • read the directions and warnings before use
  • keep the carton. It contains 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 ingredients)

D&C red no. 28, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, gelatin, hypromellose, low substituted hydroxypropyl cellulose, mannitol, meglumine, methacrylic acid copolymer, pharmaceutical ink, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-719-9260

Do Not Use If You Have: (Do not use if you have:)
  • trouble or pain swallowing food, vomiting with blood, or bloody or black stools
  • 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

These may be signs of a serious condition. See your doctor.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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, (If pregnant or breast-feeding,)

ask a health care professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Lansoprazole 15 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • had heartburn over 3 months. This may be a sign of a more serious condition.
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
Package/label Principal Display Panel (Package/Label Principal Display Panel)

GOODSENSE®

Treats Frequent Heartburn

Lansoprazole Delayed-Release Capsules 15 mg

Actual Size

Acid Reducer

24HR

• May take 1 to 4 days for full effect

• Sodium Free

Compare to active ingredient of Prevacid® 24 HR

28 Capsules

Two 14-Day Courses of Treatment

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Advanced Ingredient Data


Raw Label Data

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