LANSOPRAZOLE capsule, delayed release
lansoprazole by
Drug Labeling and Warnings
lansoprazole by is a Otc medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Active ingredient (in each capsule)
- Purpose
- Use
-
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)
-
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.
-
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
Consumer Information
Treats Frequent Heartburn
Lansoprazole
Delayed-Release Capsules 15 mg / Acid Reducer
- May take 1 to 4 days for full effect
- Sodium Free
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 or mycophenolate mofetil (immune system medicines)
- atazanavir (medicine for HIV infection)
- methotrexate (arthritis medicine)
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 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
Distributed By
Perrigo®
Allegan, MI 49010
: 3T300 00 J5
-
HOW SUPPLIED
Product: 71335-0575
NDC: 71335-0575-1 30 CAPSULE, DELAYED RELEASE in a BOTTLE
NDC: 71335-0575-2 90 CAPSULE, DELAYED RELEASE in a BOTTLE
NDC: 71335-0575-3 60 CAPSULE, DELAYED RELEASE in a BOTTLE
NDC: 71335-0575-4 58 CAPSULE, DELAYED RELEASE in a BOTTLE
NDC: 71335-0575-5 28 CAPSULE, DELAYED RELEASE in a BOTTLE
NDC: 71335-0575-6 14 CAPSULE, DELAYED RELEASE in a BOTTLE
NDC: 71335-0575-7 120 CAPSULE, DELAYED RELEASE in a BOTTLE
NDC: 71335-0575-8 180 CAPSULE, DELAYED RELEASE in a BOTTLE
- Lansoprazole DR 15mg Capsule(Rx)
-
INGREDIENTS AND APPEARANCE
LANSOPRAZOLE
lansoprazole capsule, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 71335-0575(NDC:45802-245) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG) LANSOPRAZOLE 15 mg Inactive Ingredients Ingredient Name Strength D&C RED NO. 28 (UNII: 767IP0Y5NH) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14) MANNITOL (UNII: 3OWL53L36A) MEGLUMINE (UNII: 6HG8UB2MUY) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color PINK, GREEN Score no score Shape CAPSULE Size 16mm Flavor Imprint Code L3T3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 71335-0575-3 60 in 1 BOTTLE; Type 0: Not a Combination Product 11/19/2012 2 NDC: 71335-0575-4 58 in 1 BOTTLE; Type 0: Not a Combination Product 11/19/2012 3 NDC: 71335-0575-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/19/2012 4 NDC: 71335-0575-7 120 in 1 BOTTLE; Type 0: Not a Combination Product 11/19/2012 5 NDC: 71335-0575-2 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/19/2012 6 NDC: 71335-0575-5 28 in 1 BOTTLE; Type 0: Not a Combination Product 11/19/2012 7 NDC: 71335-0575-6 14 in 1 BOTTLE; Type 0: Not a Combination Product 11/19/2012 8 NDC: 71335-0575-8 180 in 1 BOTTLE; Type 0: Not a Combination Product 11/19/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202319 08/07/2012 Labeler - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(71335-0575) , RELABEL(71335-0575)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.