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Labetalol Hcl 200 Mg Tab 100

  • Manufacturer Name : BLUEPOINT LABORATORIES
  • MFG # : 68001038200
  • NDC : 68001038200
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description -
Description N
DESI Drug Ind -
DESI Drug Ind -; -
DESI2 Drug Ind -
Drug Category N
Drug Category USES: Labetalol is used with or without other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This medication is both an alpha blocker and beta blocker. It works by blocking the action of certain natural chemicals in your body such as epinephrine on the heart and blood vessels. This effect lowers the heart rate, blood pressure, and strain on the heart.
Drug Type Code COMMON BRAND NAME(S): Normodyne, Trandate
Drug Type Code 1
FDA Approval Date 02/18/2019
FDA Therap Equiv AB
HCPCS -
HCPCS 1
Market Entry Date 06/05/2019
Medical Coverage -
Medical Coverage -
Termination Date -
Termination Date (luh-BET-uh-lol)
Unit TAB
Units Per Pkg 100
Active Ingredients 4368 labetalol HCl 32780646
Active Ingredients 4368 labetalol HCl 32780646
AHFS Class 24240000 BETA-ADRENERGIC BLOCKING AGENTS; 24200000 ALPHA-ADRENERGIC BLOCKING AGENTS; 24040416 CLASS II ANTIARRHYTHMICS; 24080400 ALPHA-ADRENERGIC BLOCKING AGT.(HYPOTEN); 24080800 BETA-ADRENERGIC BLOCKING AGT.(HYPOTEN); 12160412 SELECTIVE ALPHA-1-ADRENERGIC BLOCK.AGENT; 12160804 NON-SEL. BETA-ADRENERGIC BLOCKING AGENTS
AHFS Class 24240000 BETA-ADRENERGIC BLOCKING AGENTS; 24200000 ALPHA-ADRENERGIC BLOCKING AGENTS; 24040416 CLASS II ANTIARRHYTHMICS; 24080400 ALPHA-ADRENERGIC BLOCKING AGT.(HYPOTEN); 24080800 BETA-ADRENERGIC BLOCKING AGT.(HYPOTEN); 12160412 SELECTIVE ALPHA-1-ADRENERGIC BLOCK.AGENT; 12160804 NON-SEL. BETA-ADRENERGIC BLOCKING AGENTS
DEA Class NC
DEA Class NC
Dose Form TABLET
Dose Form TABLET
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 5099 labetalol HCl ORAL TABLET 200 MG
Gen Code and Des 5099 labetalol HCl ORAL TABLET 200 MG
Inactive Ingredients 2432 lactose 64044515
Inactive Ingredients 2432 lactose 64044515
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 200MG
Strength 200MG
Common Brand Name COMMON BRAND NAME(S): Normodyne, Trandate
Common Brand Name -
Drug Interaction -
Drug Interaction DRUG INTERACTIONS: See also Precautions section. 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. Some products that may interact with this drug include: cimetidine, fingolimod. Some products have ingredients that could raise your heart rate or blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or NSAIDs such as ibuprofen/naproxen). This medication may interfere with certain medical/laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
Allocation Period -
Allocation Period -
Case Quantity 24
Case Quantity 24
Drug Form Pack Size 100
Drug Form Pack Size 100
Form TABLET
Form TABLET
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
Orange Book AB Products meeting necessary bioequivalence requirements.
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit Size 100
Unit Size 100
How to Use HOW TO USE: See also Warning section. Take this medication by mouth as directed by your doctor, usually twice a day. You may take this medication with or without food, but it is important to choose one way and take this medication the same way with every dose. Dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. For the treatment of high blood pressure, it may take several weeks before you get the full benefit of this drug. Keep taking this medication even if you feel well. Most people with high blood pressure do not feel sick. Tell your doctor if your condition does not improve or if it worsens (for example, your blood pressure readings remain high or increase).
How to Use -
Missed Dose 100
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.
Notes NOTES: Do not share this medication with others. Talk with your doctor about making changes to your lifestyle that may help this medication work better (such as stress reduction programs, exercise, and dietary changes). Have your blood pressure and pulse (heart rate) checked regularly while taking this medication. Learn how to check your own blood pressure and pulse at home, and share the results with your doctor. Lab and/or medical tests (such as liver function) should be done while you are taking this medication. 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: very slow heartbeat, severe dizziness, severe weakness, fainting, trouble breathing.
Phonetic Pronunciation (luh-BET-uh-lol)
Phonetic Pronunciation -
Precautions -
Precautions PRECAUTIONS: Before taking labetalol, tell your doctor or pharmacist if you are allergic to it; 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: heart problems (such as heart failure, slow heartbeat, second- or third-degree atrioventricular block), breathing problems (such as asthma, chronic bronchitis, emphysema), kidney disease, liver disease, overactive thyroid disease (hyperthyroidism), serious allergic reactions including those needing treatment with epinephrine, blood circulation problems (such as Raynaud's disease, peripheral vascular disease), mental/mood disorders (such as depression), a certain muscle disease (myasthenia gravis), certain eye problems (cataracts, glaucoma). This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery (including cataract/glaucoma eye surgery), tell your doctor or dentist if you are taking or have ever taken this medication, and about all the other products you use (including prescription drugs, nonprescription drugs, and herbal products). This product may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). The risk is higher if you have diabetes, or are vomiting, fasting, or not eating regularly. Other symptoms of low blood sugar level, such as dizziness and sweating, are not affected by this drug. If you have diabetes, this product may make it harder to control your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet. Children may be at greater risk for low blood sugar (hypoglycemia) while using this drug, especially if they are vomiting or not eating regularly. To help prevent low blood sugar, make sure children eat regularly. If your child cannot eat regularly, is vomiting, or has symptoms of low blood sugar (such as sweating, shaking), tell the doctor right away. Older adults may be more sensitive to the side effects of this drug, including dizziness and lightheadedness. These side effects can increase the risk of falling. Labetalol has been used to treat high blood pressure in pregnant women. It is important to control high blood pressure for the health of the mother and unborn baby. If you are planning pregnancy, become pregnant, or think you may be pregnant, discuss with your doctor the benefits and risks of using this medication during pregnancy. Rarely, babies born to mothers who took labetalol during pregnancy may have symptoms of low blood pressure, slow heartbeat, slow breathing, and low blood sugar (such as shaking, unusual sweating) for a few days after delivery. Tell the doctor right away if you notice any of these symptoms in your newborn. This medication passes into breast milk, and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: See also Warning and Precautions sections. Dizziness and tiredness may occur. Scalp tingling may also occur as your body adjusts to the medication. Decreased sexual ability has been reported rarely. If any of these effects last or get worse, tell your doctor or pharmacist promptly. To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. This drug may reduce blood flow to your hands and feet, causing them to feel cold. Smoking may worsen this effect. Dress warmly and avoid tobacco use. 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. Tell your doctor right away if you have any serious side effects, including: very slow heartbeat, severe dizziness, fainting, blue fingers/toes, new or worsening symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain), mental/mood changes (such as confusion, mood swings, depression). This drug may rarely cause serious (rarely fatal) liver disease. If you notice any of the following rare but serious side effects, get medical help right away: nausea/vomiting that doesn't stop, severe stomach/abdominal pain, yellowing eyes/skin, dark urine. 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: 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 STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. 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 02/18/2019
Uses -
Uses USES: Labetalol is used with or without other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This medication is both an alpha blocker and beta blocker. It works by blocking the action of certain natural chemicals in your body such as epinephrine on the heart and blood vessels. This effect lowers the heart rate, blood pressure, and strain on the heart.

Frequently Asked Questions(FAQs)

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Labetalol Hcl 200 Mg Tab 100 is manufactured by BLUEPOINT LABORATORIES.
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