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NDC 62175-0515-12 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 Lannett Company, Inc.. 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: 62175-0515-12Last 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: 62175-0515-12Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Lansoprazole, Clarithromycin, and Amoxicillin
Product Information
| NDC | 62175-0515 |
|---|---|
| Product ID | 62175-515_9d4be625-fedb-4b0a-bfcf-b8b513eeec8c |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Lansoprazole |
| Proprietary Name Suffix | 24 HR |
| 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 | Lannett Company, Inc. |
| Pharmaceutical Class | Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA207157 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 62175-0515-12 (62175051512)
| NDC Package Code | 62175-515-12 |
|---|---|
| Billing NDC | 62175051512 |
| Package | 2 BOTTLE in 1 PACKAGE, COMBINATION (62175-515-12) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE |
| Marketing Start Date | 2017-09-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b5b4e61e-91c5-41bd-a16d-e25d9be2c87e Details
Uses
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 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 Course of Treatment (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
ammonium hydroxide, black iron oxide, butyl alcohol, dehydrated alcohol, FD&C Blue #1, FD&C Red #40, gelatin, hypromellose, iron oxide yellow, isopropyl alcohol, magnesium carbonate, mannitol, methacrylic acid and ethyl acrylate copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, sodium lauryl sulfate, sodium starch glycolate, sugar sphere, talc, titanium dioxide
Questions or Comments
INGREDIENTS AND APPEARANCE
| LANSOPRAZOLE
24 HR
lansoprazole capsule, delayed release |
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| Labeler - Lannett Company, Inc. (006422406) |