Product Details
MESALAMINE 800 MG DR TAB 180
Manufacturer: ZYDUS PHARMACEUTICALS USA INC
MFG#: 68382-0435-28
NDC: 68382-0435-28
PID: 304692
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Product Properties:
| Description | N |
|---|---|
| Description | - |
| Description | N |
| DESI Drug Ind | -; - |
| DESI Drug Ind | - |
| DESI Drug Ind | -; - |
| DESI2 Drug Ind | - |
| Drug Category | N |
| Drug Category | USES: This medication is used to treat a certain bowel disease (ulcerative colitis). It helps to reduce symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and stomach pain. Mesalamine belongs to a class of drugs known as aminosalicylates. It works by decreasing swelling in the colon. |
| Drug Category | USES: This medication is used to treat a certain bowel disease (ulcerative colitis). It helps to reduce symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and stomach pain. Mesalamine belongs to a class of drugs known as aminosalicylates. It works by decreasing swelling in the colon. |
| Drug Type Code | COMMON BRAND NAME(S): Asacol, Delzicol |
| Drug Type Code | COMMON BRAND NAME(S): Asacol, Delzicol |
| Drug Type Code | 1 |
| FDA Approval Date | 07/21/2017 |
| FDA Therap Equiv | AB |
| HCPCS | - |
| HCPCS | 1 |
| HCPCS | 1 |
| Market Entry Date | 08/06/2018 |
| Medical Coverage | - |
| Medical Coverage | - |
| Medical Coverage | - |
| Termination Date | (me-SAL-a-meen/a-MEE-noe-sal-i-SIL-ik AS-id) |
| Termination Date | (me-SAL-a-meen/a-MEE-noe-sal-i-SIL-ik AS-id) |
| Termination Date | - |
| Unit | TAB |
| Units Per Pkg | 1 |
| Active Ingredients | 1600 mesalamine 89576 |
| Active Ingredients | 1600 mesalamine 89576 |
| Active Ingredients | 1600 mesalamine 89576 |
| AHFS Class | 56360000 ANTI-INFLAMMATORY AGENTS (GI DRUGS) |
| AHFS Class | 56360000 ANTI-INFLAMMATORY AGENTS (GI DRUGS) |
| AHFS Class | 56360000 ANTI-INFLAMMATORY AGENTS (GI DRUGS) |
| DEA Class | NC |
| DEA Class | NC |
| DEA Class | NC |
| Dose Form | TABLET, DELAYED RELEASE (ENTERIC COATED) |
| Dose Form | TABLET, DELAYED RELEASE (ENTERIC COATED) |
| Dose Form | TABLET, DELAYED RELEASE (ENTERIC COATED) |
| Fine Line Class | 850085008510 All Rx Products |
| Fine Line Class | 850085008510 All Rx Products |
| Fine Line Class | 850085008510 All Rx Products |
| Gen Code and Des | 53882 mesalamine ORAL TABLET DR 800 MG |
| Gen Code and Des | 53882 mesalamine ORAL TABLET DR 800 MG |
| Gen Code and Des | 53882 mesalamine ORAL TABLET DR 800 MG |
| Inactive Ingredients | 2537 povidone 9003398 |
| Inactive Ingredients | 2537 povidone 9003398 |
| Inactive Ingredients | 2537 povidone 9003398 |
| OMP Family | - |
| OMP Family | - |
| OMP Family | - |
| Product Category | RX Pharmaceuticals |
| Product Category | RX Pharmaceuticals |
| Product Category | RX Pharmaceuticals |
| Strength | 800MG DR |
| Strength | 800MG DR |
| Strength | 800MG DR |
| Common Brand Name | COMMON BRAND NAME(S): Asacol, Delzicol |
| Common Brand Name | - |
| Common Brand Name | - |
| Drug Interaction | DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Mesalamine is very similar to balsalazide, olsalazine, and sulfasalazine. Do not use medications containing balsalazide, olsalazine, or sulfasalazine while using mesalamine. This medication may interfere with certain laboratory tests (including urine normetanephrine levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug. |
| Drug Interaction | - |
| Drug Interaction | - |
| Allocation Period | - |
| Allocation Period | - |
| Allocation Period | - |
| Case Quantity | 12 |
| Case Quantity | 12 |
| Case Quantity | 12 |
| Drug Form Pack Size | 180 |
| Drug Form Pack Size | 180 |
| Drug Form Pack Size | 180 |
| Form | TABLET |
| Form | TABLET |
| Form | TABLET |
| Hazard Code | - |
| Hazard Code | - |
| Hazard Code | - |
| Listed Chemical | - |
| Listed Chemical | - |
| Listed Chemical | - |
| NIOSH Code | - |
| NIOSH Code | - |
| NIOSH Code | - |
| Orange Book | AB Products meeting necessary bioequivalence requirements. |
| Orange Book | AB Products meeting necessary bioequivalence requirements. |
| Orange Book | AB Products meeting necessary bioequivalence requirements. |
| Retail Pack Quantity | 1 |
| Retail Pack Quantity | 1 |
| Retail Pack Quantity | 1 |
| Returnable Status | Returnable |
| Returnable Status | Returnable |
| Returnable Status | Returnable |
| Special Storage Cond | 00 None |
| Special Storage Cond | 00 None |
| Special Storage Cond | 00 None |
| Temp Zone | 10 Room Temperature |
| Temp Zone | 10 Room Temperature |
| Temp Zone | 10 Room Temperature |
| Unit | EA |
| Unit | EA |
| Unit | EA |
| Unit Size | 180 |
| Unit Size | 180 |
| Unit Size | 180 |
| How to Use | - |
| How to Use | - |
| How to Use | HOW TO USE: Take this medication by mouth with or without food as directed by your doctor, usually 3 times daily. Some brands should be taken on an empty stomach at least 1 hour before or 2 hours after a meal. Consult your doctor or pharmacist for details for your particular brand. Swallow this medication whole. Do not crush, chew, or break. Doing so can keep the drug from being released properly into the colon. Drink plenty of fluids during treatment with this medication unless otherwise directed by your doctor. This will help prevent kidney stones. The dosage is based on your medical condition and response to treatment. In children, the dosage is also based on weight. Different brands of this medication deliver different amounts of medication. Do not switch brands without your doctor's permission and directions. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Tell your doctor if your condition does not improve or if it worsens. |
| Missed Dose | 1 |
| Missed Dose | MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. |
| Missed Dose | 1 |
| Notes | TAB |
| Notes | NOTES: Do not share this medication with others. Lab and/or medical tests (such as liver/kidney function) may be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details. |
| Notes | TAB |
| Overdose | AB |
| Overdose | OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: ringing in the ears, confusion, rapid breathing, seizures. |
| Overdose | AB |
| Phonetic Pronunciation | - |
| Phonetic Pronunciation | - |
| Phonetic Pronunciation | (me-SAL-a-meen/a-MEE-noe-sal-i-SIL-ik AS-id) |
| Precautions | - |
| Precautions | PRECAUTIONS: Before taking mesalamine, tell your doctor or pharmacist if you are allergic to it; or to other aminosalicylates (such as balsalazide, olsalazine); or to salicylates (such as aspirin, salsalate); or to sulfasalazine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, stomach blockage (such as pyloric stenosis). This medication may make you more sensitive to the sun, especially if you have skin problems (such as atopic dermatitis, eczema). Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This medication is similar to aspirin. Children and teenagers younger than 18 years should not take aspirin or aspirin-related medications (such as salicylates) if they have chickenpox, flu, or any undiagnosed illness, or if they have recently received a vaccine. In these cases, taking aspirin increases the risk of Reye's syndrome, a rare but serious illness. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding. |
| Precautions | - |
| Side Effects | - |
| Side Effects | SIDE EFFECTS: Stomach upset, nausea/vomiting, constipation, headache, or joint/muscle pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. You may sometimes see whole or partial tablets/capsules in your stool. If this occurs often, tell your doctor. You may not be absorbing enough of the medication. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Rarely, mesalamine can worsen ulcerative colitis. Tell your doctor right away if your symptoms worsen after starting this medication (such as increased abdominal pain/cramping, bloody diarrhea). Tell your doctor right away if you have any serious side effects, including: nausea/vomiting that doesn't stop, signs of kidney problems (such as change in the amount of urine, blood in the urine), dark urine, severe stomach/abdominal pain, yellowing eyes/skin, chest pain, shortness of breath. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. |
| Side Effects | - |
| Storage | 07/21/2017 |
| Storage | STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. If your medication bottle comes with a desiccant, keep the desiccant in the bottle with the medication. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. |
| Storage | 07/21/2017 |
| Uses | - |
| Uses | - |
| Uses | USES: This medication is used to treat a certain bowel disease (ulcerative colitis). It helps to reduce symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and stomach pain. Mesalamine belongs to a class of drugs known as aminosalicylates. It works by decreasing swelling in the colon. |
Frequently Asked Questions (FAQs)
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MESALAMINE 800 MG DR TAB 180 is manufactured by ZYDUS PHARMACEUTICALS USA INC.
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