Berkley and Jensen Lansoprazole description, usages, side effects, indications, overdosage, supplying and lots more!

Berkley and Jensen Lansoprazole

BJWC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
BJWC Lansoprazole Delayed-Release Capsules 15 mg Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each capsule)

Lansoprazole 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 (immune system medicine)
  • •atazanavir (medicine for HIV infection)

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

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 20-25˚C (68-77˚F)
  • •keep product out of high heat and humidity
  • •protect product from moisture

Inactive ingredients

D&C red no. 28, D&C yellow no. 10, FD&C blue no. 1, 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?

1-800-934-1204

Consumer Information

Lansoprazole Delayed-Release Capsules 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 15 mg.

Save for future reference.

How Lansoprazole Delayed-Release Capsules 15 mg Treats Your Frequent Heartburn

Lansoprazole Delayed-Release Capsules 15 mg stops acid production at the source – the pumps that release acid into the stomach. Lansoprazole Delayed-Release Capsules 15 mg is taken once a day (every 24 hours), every day for 14 days.

What You Can Expect When Taking Lansoprazole Delayed-Release Capsules 15 mg

Frequent heartburn can occur anytime during the 24-hour period (day or night). Take Lansoprazole Delayed-Release Capsules 15 mg in the morning before eating. Lansoprazole Delayed-Release Capsules 15 mg is 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 15 mg every day for 14 days to treat your frequent heartburn.

Who Should Take Lansoprazole Delayed-Release Capsules 15 mg

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 15 mg

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 15 mg

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 15 mg 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 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 (immune system medicine)
  • •atazanavir (medicine for HIV infection)

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

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)

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 15 mg effectively treats frequent heartburn

In three clinical studies, Lansoprazole Delayed-Release Capsules 15 mg was shown to be significantly better than placebo in treating frequent heartburn.

How Lansoprazole Delayed-Release Capsules 15 mg is Sold

Lansoprazole Delayed-Release Capsules 15 mg is 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 15 mg

Call 1-800-719-9260

:3T300 00 J3

Package/Label Principal Display Panel

ACID REDUCER

24 HR LANSOPRAZOLE DELAYED-RELEASE CAPSULES 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

Compare to the active ingredient of Prevacid® 24 HR

ACTUAL SIZE

3 BOTTLES – 14 CAPSULES EACH

42 TOTAL CAPSULES

THREE 14-DAY COURSES OF TREATMENT

GLUTEN FREE

Berkley and Jensen Lansoprazole

Lansoprazole CAPSULE, DELAYED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68391-117
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
lansoprazole LANSOPRAZOLE 15 mg

Inactive Ingredients

Ingredient Name Strength
D&C RED NO. 28
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GELATIN
HYPROMELLOSES
mannitol
MEGLUMINE
POLYETHYLENE GLYCOLS
polysorbate 80
SODIUM LAURYL SULFATE
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
GREEN 16 mm L3T3 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 14 in 1 BOTTLE
2 NDC:68391-117-03 3 in 1 PACKAGE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202319 2012-05-22


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