LANSOPRAZOLE capsule, delayed release
Lansoprazole by
Drug Labeling and Warnings
Lansoprazole by is a Otc medication manufactured, distributed, or labeled by Dr. Reddy's Laboratories Inc., Dr.Reddy's Laboratories Limited (FTO III). 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 a prescription drug. Acid reducers may interact with certain prescription drugs.
-
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 days
- 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
-
Inactive ingredients
FD&C Blue No. 2, gelatin, hydroxypropyl cellulose, iron oxide black, iron oxide red, iron oxide yellow, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol 6000, polysorbate 80, sodium lauryl sulphate, starch (corn), sucrose, sugar spheres, talc, titanium dioxide
- Questions or comments?
-
SPL UNCLASSIFIED SECTION
Consumer Information
Lansoprazole Delayed-Release Capsules USP, 15 mg / Acid Reducer
Treats Frequent Heartburn
May take 1 to 4 days for full effect
Please read the entire package insert before taking Lansoprazole Delayed-Release Capsules USP, 15 mg. Save for future reference.
How Lansoprazole Delayed-Release Capsules USP, 15 mg Treat Your Frequent Heartburn
Lansoprazole Delayed-Release Capsules USP, 15 mg stops acid production at the source - the pumps that release acid into the stomach. Lansoprazole Delayed-Release Capsules USP, 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 USP, 15 mg
Frequent heartburn can occur anytime during the 24-hour period (day or night). Take Lansoprazole Delayed-Release Capsules USP, 15 mg in the morning before eating. Lansoprazole Delayed-Release Capsules USP, 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 USP, 15 mg every day for 14 days to treat your frequent heartburn.
Who Should Take Lansoprazole Delayed-Release Capsules USP, 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 USP, 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 USP, 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 USP, 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 a prescription drug. Acid reducers may interact with certain prescription drugs.
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 USP, 15 mg effectively treat frequent heartburn
In three clinical studies, Lansoprazole Delayed-Release Capsules USP, 15 mg was shown to be significantly better than placebo in treating frequent heartburn.
How Lansoprazole Delayed-Release Capsules USP, 15 mg is Sold
Lansoprazole Delayed-Release Capsules USP, 15 mg 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 USP, 15 mg
Call 1-888-375-3784
Manufactured by:
Dr. Reddy's Laboratories Limited
Bachupally - 500 090 INDIA
- Carton Label
- Container Label
-
INGREDIENTS AND APPEARANCE
LANSOPRAZOLE
lansoprazole capsule, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 43598-883(NDC:55111-739) 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 FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) GELATIN (UNII: 2G86QN327L) HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Hydroxypropyl Cellulose, Low Substituted (UNII: 2165RE0K14) MAGNESIUM CARBONATE (UNII: 0E53J927NA) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color PINK (opaque pink colored cap) , GREEN (opaque green colored body) Score no score Shape CAPSULE Size 3mm Flavor Imprint Code RDY;398 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 43598-883-52 1 in 1 CARTON 08/01/2019 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC: 43598-883-42 3 in 1 CARTON 08/01/2019 2 14 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202194 08/01/2019 Labeler - Dr. Reddy's Laboratories Inc. (802315887) Establishment Name Address ID/FEI Business Operations Dr.Reddy's Laboratories Limited (FTO III) 918608162 manufacture(43598-883) , analysis(43598-883)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.