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NDC 71713-0201-03 Omeprazole 20 mg/1 Details
Omeprazole 20 mg/1
Omeprazole is a ORAL TABLET, DELAYED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Thirty Madison Inc. The primary component is OMEPRAZOLE.
MedlinePlus Drug Summary
Prescription omeprazole is used alone or with other medications 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 omeprazole is used to treat damage from GERD in adults and children 1 month of age and older. Prescription omeprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults and children 1 year of age and older with GERD. Prescription omeprazole is also used to treat conditions in which the stomach produces too much acid such as Zollinger-Ellison syndrome in adults. Prescription omeprazole is also used to treat ulcers (sores in the lining of the stomach or intestine) and it is also used with other medications to treat and prevent the return of ulcers caused by a certain type of bacteria (H. pylori) in adults. Nonprescription (over-the-counter) omeprazole is used to treat frequent heartburn (heartburn that occurs at least 2 or more days a week) in adults. Omeprazole is in a class of medications called proton-pump inhibitors. It works by decreasing the amount of acid made in the stomach.
Related Packages: 71713-0201-03Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Omeprazole
Product Information
| NDC | 71713-0201 |
|---|---|
| Product ID | 71713-201_b3d11bd8-0ac3-363e-2e46-03fc1366a56a |
| 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 | Omeprazole |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Omeprazole |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, DELAYED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/1 |
| Substance Name | OMEPRAZOLE |
| Labeler Name | Thirty Madison Inc |
| Pharmaceutical Class | Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA207740 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 71713-0201-03 (71713020103)
| NDC Package Code | 71713-201-03 |
|---|---|
| Billing NDC | 71713020103 |
| Package | 3 BOTTLE in 1 CARTON (71713-201-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE |
| Marketing Start Date | 2019-05-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b7289621-9dc7-fd2b-bbb1-f69dea450f7d Details
Use
WARNINGS SECTION
Do not use if you have
• Trouble or pain swallowing food, vomiting with blood, or bloody or black stools • 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
These may be signs of a serious condition. See your doctor.
Ask a doctor before use if you have:
• had heartburn over 3 months. This may be a sign of a more serious condition
• frequent wheezing, particularly with heartburn
• unexplained weight loss
• nausea or vomiting
• stomach pain
Ask a doctor or Pharmacist beofre using if you are
taking:
• warfarin, clopidogrel or cilostazol (blood thinning medications)
• prescription antifungal or anti-yeast medicines
• diazepam (anxiety medicine)
• digoxin (heart medicine)
• tacrolimus or mycophenolate mofetil (immune system medicines)
• prescription antiretrovirals (medicines for HIV infection)
• methotrexate (arthritis medicine)
Directions
• for 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, some people get relief of symptoms within 24 hours
• 14 day course of treatment
•swallow 1 tablet with a glass of water befre eating in the morning • take every day for 14 days • do not take more than 1 tablet a day • do not use for more than 14 days unless directed by your doctor • swallow whole. Do not chew or crush tablets
• Repeated 14 days 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. Heartburn in children may sometimes be caused by a serious condition.
Other Information
Inactive Ingredients
ammonia solution, ammonium hydroxide, carnauba wax, hypromellose acetate succinate, hypromellose, iron oxide black, lactose monohydrate, monoethanolamine, n-butyl alcohol, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, red iron oxide, sodium stearate, sodium starch glycolate, shellac glaze, sodium lauryl sulphate, sodium stearyl fumarate, talc, titanim dioxide, triethyl citrate, yellow iron oxide
Tips for Managing Heartburn
• Do not lie flat or bend over after eating
• Do not wear tight-fitting clothing around the stomach
• Do not eat before bedtime
• Raise the head of your bed
• Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol and certain fruits and vegetables
• Eat slowly and avoid big meals
• If overweight, lose weight
• Quit smoking
INGREDIENTS AND APPEARANCE
| OMEPRAZOLE
omeprazole tablet, delayed release |
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| Labeler - Thirty Madison Inc (080774087) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Dr.Reddy's Laboratories Limited (SEZ UNIT) | 860037244 | analysis(71713-201) , manufacture(71713-201) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Reed Lane Inc | 001819879 | repack(71713-201) | |