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NDC 63868-0429-42 Lansoprazole 15 mg/1 Details
Lansoprazole 15 mg/1
Lansoprazole is a ORAL CAPSULE, DELAYED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Chain Drug Marketing Association. The primary component is LANSOPRAZOLE.
MedlinePlus Drug Summary
Prescription lansoprazole is used to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 1 year of age and older. Prescription lansoprazole is used to treat the damage from GERD in adults and children 1 year of age and older. Prescription lansoprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults with GERD. Prescription lansoprazole is also used to treat ulcers (sores in the lining of the stomach or intestine), to prevent more ulcers from developing in adults whose ulcers have already healed, and to decrease the risk that adults who are taking nonsteroidal anti-inflammatory drugs (NSAIDs) will develop ulcers. Prescription lansoprazole is also used to treat conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome in adults. Prescription lansoprazole is also used in combination with other medications to treat and prevent stomach ulcers caused by a certain type of bacteria (H. pylori) in adults. Nonprescription (over-the-counter) lansoprazole is used to treat frequent heartburn (heartburn that occurs two or more days per week) in adults. Lansoprazole is in a class of medications called proton pump inhibitors. It works by decreasing the amount of acid made in the stomach.
Related Packages: 63868-0429-42Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Lansoprazole
Lansoprazole, clarithromycin, and amoxicillin are used to treat and prevent the return of ulcers (sores in the lining of the stomach or intestine) caused by a certain type of bacteria (H. pylori). Lansoprazole is in a class of medications called proton pump inhibitors. Clarithromycin and amoxicillin are in a class of medications called antibiotics. Lansoprazole works by decreasing the amount of acid made in the stomach. Clarithromycin and amoxicillin work by stopping the growth of the bacteria that may cause ulcers. Antibiotics will not work for colds, flu, or other viral infections.
Related Packages: 63868-0429-42Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Lansoprazole, Clarithromycin, and Amoxicillin
Product Information
| NDC | 63868-0429 |
|---|---|
| Product ID | 63868-429_236ccaaa-8eea-b6c0-575c-d3de258b751a |
| Associated GPIs | 49270040006510 |
| GCN Sequence Number | 030106 |
| GCN Sequence Number Description | lansoprazole CAPSULE DR 15 MG ORAL |
| HIC3 | D4J |
| HIC3 Description | PROTON-PUMP INHIBITORS |
| GCN | 01697 |
| HICL Sequence Number | 008993 |
| HICL Sequence Number Description | LANSOPRAZOLE |
| Brand/Generic | Generic |
| Proprietary Name | Lansoprazole |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Lansoprazole |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CAPSULE, DELAYED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 15 |
| Active Ingredient Units | mg/1 |
| Substance Name | LANSOPRAZOLE |
| Labeler Name | Chain Drug Marketing Association |
| Pharmaceutical Class | Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA202194 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63868-0429-42 (63868042942)
| NDC Package Code | 63868-429-42 |
|---|---|
| Billing NDC | 63868042942 |
| Package | 3 BOTTLE in 1 CARTON (63868-429-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE |
| Marketing Start Date | 2019-09-13 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.46663 |
| Pricing Unit | EA |
| Effective Date | 2022-11-23 |
| NDC Description | LANSOPRAZOLE DR 15 MG CAPSULE |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2022-11-23 |
Standard Product Labeling (SPL)/Prescribing Information SPL 5aaa28e5-bfb2-2c85-3996-19404354ed39 Details
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
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
INGREDIENTS AND APPEARANCE
| LANSOPRAZOLE
lansoprazole capsule, delayed release |
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| Labeler - Chain Drug Marketing Association (011920774) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Dr.Reddy's Laboratories Limited (FTO III) | 918608162 | manufacture(63868-429) , analysis(63868-429) | |