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Lansoprazole by Sam's West, Inc.

Medically reviewed on July 21, 2017

Dosage form: capsule, delayed release
Ingredients: LANSOPRAZOLE 15mg
Labeler: Sam's West, Inc.
NDC Code: 68196-030

Lansoprazole DR Capsules USP 15 mg

Active ingredient (in each capsule)

Lansoprazole USP, 15 mg

Purpose

Acid reducer

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

Do not use
  • 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
  • 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 taking
  • warfarin (blood-thinning medicine)
  • prescription antifungal or anti-yeast medicines
  • digoxin (heart medicine)
  • theophylline (asthma medicine)
  • tacrolimus or mycophenolate mofetil (immune system medicines)
  • atazanavir (medicine for HIV infection)
  • methotrexate (arthritis medicine)
  • presently taking a prescription drug.  Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if
  • you get diarrhea
  • 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

If pregnant or breast-feeding,

ask a health 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).

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, warnings and package insert before use
  • keep the package and package insert.  They contain important information.
  • Store at 20-25ºC (68-77ºF).
  • Protect from moisture.

Inactive ingredients

black iron oxide, colloidal silicon dioxide, corn starch, FD&C Blue No. 1, FD&C Red No. 3, FD&C Red No. 40, gelatin, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, potassium hydroxide, propylene glycol, shellac, strong ammonia solution, sucrose, sugar spheres, talc, titanium dioxide, yellow iron oxide

Questions or comments?

1-877-446-3679 (1-877-4-INFO-RX).

Consumer Information

LANSOPRAZOLE DELAYED-RELEASE CAPSULES, USP

(lan soepra zole)

15 mg

          Acid Reducer

• May take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours.

Please read the entire package insert before taking lansoprazole delayed-release capsules. Save for future reference.

How Lansoprazole Delayed-Release Capsules Treat Your Frequent Heartburn

Lansoprazole delayed-release capsules stop acid production at the source – the pumps that release acid into the stomach. Lansoprazole delayed-release capsules are taken once a day (every 24 hours), every day for 14 days.

What You Can Expect When Taking Lansoprazole Delayed-Release Capsules

Frequent heartburn can occur anytime during the 24-hour period (day or night). Take lansoprazole delayed-release capsules in the morning before eating. Lansoprazole delayed-release capsules are clinically proven to treat frequent heartburn. Although some people get complete relief of symptoms within 24 hours, it may take 1 to 4 days for full effect. Make sure you take lansoprazole delayed-release capsules every day for 14 days to treat your frequent heartburn.

Who Should Take Lansoprazole Delayed-Release Capsules

Adults (18 years and older) with frequent heartburn – when you have heartburn 2 or more days a week.

Who Should NOT Take Lansoprazole Delayed-Release Capsules

People who have one episode of heartburn a week or less, or who want immediate relief of heartburn.

How to Take Lansoprazole Delayed-Release Capsules 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.

When to Take Lansoprazole Delayed-Release Capsules Again

You may repeat a 14-day course of therapy every 4 months.

When to Talk to Your Doctor

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

Warnings and When to Ask Your Doctor

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

Do not use

• 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 your doctor before use if you have

• 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 taking

• warfarin (blood-thinning medicine)

• prescription antifungal or anti-yeast medicines

• digoxin (heart medicine)

• theophylline (asthma medicine)

• tacrolimus or mycophenolate mofetil (immune system medicines)

• atazanavir (medicine for HIV infection)

• methotrexate (arthritis medicine)

Stop use and ask a doctor if

• you get diarrhea

• 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

If pregnant or breast-feeding, ask a health professional before use.

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

Tips for Managing Heartburn

• Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables.

• Eat slowly and do not eat big meals.

• Do not eat late at night or just before bedtime.

• Do not lie flat or bend over soon after eating.

• Raise the head of your bed.

• Wear loose-fitting clothing around your stomach.

• If you are overweight, lose weight.

• If you smoke, quit smoking.

Clinical studies prove lansoprazole delayed-release capsules effectively treat frequent heartburn

In three clinical studies, lansoprazole delayed-release capsules were shown to be significantly better than placebo in treating frequent heartburn.

How Lansoprazole Delayed-Release Capsules are Sold

Lansoprazole delayed-release capsules are available in 14 capsule, 28 capsule and 42 capsule sizes. These sizes contain one, two and three 14-day courses of treatment, respectively. Do not use for more than 14 days in a row unless directed by your doctor. For the 28 count (two 14-day courses) and the 42 count (three 14-day courses), you may repeat a 14-day course every 4 months.

For Questions or Comments About Lansoprazole Delayed-Release Capsules

Call Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).

 

Revised: 4/2016

PRINCIPAL DISPLAY PANEL

Compare to Prevacid® 24HR active ingredient*

NDC 68196-030-03

Member's MarkTM

24 hour

lansoprazole delayed-release capsules USP 15 mg

acid reducer

  • May take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours
  • Clinically proven to treat frequent heartburn
  • Sodium free

Value 3 Pack

actual size

42 Capsules

Three 14-day courses of treatment

KEEP THE PACKAGE AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING OR BLACK BAND AROUND THE CENTER OF EACH CAPSULE IS MISSING OR BROKEN.

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Prevacid® 24HR.

LABORATORY TESTED - QUALITY ASSURED

GLUTEN FREE

100% MONEY BACK GUARANTEE

QUALITY AND PERFORMANCE

We would like to hear from you with any comments or suggestions.

In the continental U.S. or Canada, you can call us at 1-877-446-3679 (1-877-4-INFO-RX)

from 7:30 a.m. to 5 p.m. ET Monday - Friday.

DISTRIBUTED BY:

SAM'S WEST, INC.

BENTONVILLE, AR 72716

 

Lansoprazole DR Capsules USP 15 mg

PRINCIPAL DISPLAY PANEL

Lansoprazole

LANSOPRAZOLE 
lansoprazole delayed release capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-030
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANSOPRAZOLE (LANSOPRAZOLE) LANSOPRAZOLE15 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM CARBONATE 
STARCH, CORN 
FERROSOFERRIC OXIDE 
SILICON DIOXIDE 
FD&C BLUE NO. 1 
FD&C RED NO. 3 
FD&C RED NO. 40 
GELATIN 
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
POTASSIUM HYDROXIDE 
PROPYLENE GLYCOL 
SHELLAC 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
FERRIC OXIDE YELLOW 
HYDROXYPROPYL CELLULOSE (TYPE H) 
AMMONIA 
Product Characteristics
ColorGREEN (green opaque cap; pink opaque body) Scoreno score
ShapeCAPSULESize18mm
FlavorImprint CodeMYL;LD15
Contains    
Packaging
#Item CodePackage Description
1NDC:68196-030-033 BOTTLE in 1 PACKAGE
1NDC:68196-030-0114 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20318707/06/2017
Labeler - Sam's West, Inc. (051957769)

 
Sam's West, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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