Lansoprazole Delayed-Release Capsules USP
Drug Labeling and Warnings
Drug Details [pdf]
LANSOPRAZOLE- lansoprazole capsule, delayed release
Actavis Pharma, Inc.
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Lansoprazole Delayed-Release Capsules USP
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
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 medication)
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
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 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 carton and package insert. They contain important information.
store at 20° to 25°C (68° to 77°F)
keep product out of high heat and humidity
protect product from moisture
close cap tightly after use
Inactive ingredients
acetone, D&C Red #28, D&C Yellow #10, FD&C Blue #1, gelatin, hypromellose, isopropyl alcohol, light magnesium carbonate, methacrylic acid copolymer type C, polyethylene glycol 4000, polysorbate 80, sugar spheres (which contain sucrose and starch), talc, titanium dioxide. Printing Ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, strong ammonia solution, titanium dioxide
Principal Display Panel
Actavis™
NDC 0591-2448-14
Compare to the active ingredient in Prevacid® 24 HR*
Treats Frequent Heartburn
Lansoprazole
Delayed-Release Capsules USP, 15 mg
Acid Reducer
24 Hour
May take 1 to 4 days for full effect
Sodium Free
Does not contain an ingredient derived from wheat, barley or rye
One 14-Day Course of Treatment
14 capsules
| LANSOPRAZOLE
lansoprazole capsule, delayed release |
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| Labeler - Actavis Pharma, Inc. (119723554) |
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