Labetalol Hydrochloride 100 mg Tablet, 60-count
Other active recalls for Labetalol Hydrochloride (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the beta-Adrenergic Blocker class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Labetalol is used to treat high blood pressure. Labetalol is in a class of medications called beta blockers. It works by relaxing blood vessels and slowing heart rate to improve blood flow and decrease blood pressure.
Read the full MedlinePlus article ↗- Labetalol is used to lower high blood pressure (hypertension). The tablet form is for ongoing daily management of hypertension, and can be used on its own or with other blood press...
- Please don't stop labetalol on your own, even if you feel great — this is really important. Stopping suddenly, especially if you have coronary artery disease (even undiagnosed), ca...
- Is it okay to stop taking labetalol if I feel fine?
- Yes, this is a known effect. Labetalol lowers blood pressure more when you're standing than lying down, which can cause lightheadedness when you get up quickly — especially 2 to 4...
Patient education
Supplement & herbal interactions
Labetalol may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
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UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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UNII R75537T0T4
Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in liquids.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
11 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.084 | $5.04 / 60 tablets |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.1818 | $10.91 / 60 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Labetalol Hydrochloride 100 mg 71247-0126-01 | Innogenix, | 100 tablets | $0.083 | AB | FDA listed | save 1% |
| Labetalol hydrochloride 100 mg 00591-0605-01 | Actavis | 100 tablets | $0.084 | AB | Availability likely | — |
| Labetalol Hydrochloride 100 mg 00904-7451-61 | Major | 1 tablet | $0.084 | AB | Availability likely | — |
| Labetalol Hydrochloride 100 mg 23155-0723-01 | Heritage | 100 tablets | $0.084 | AB | Availability likely | — |
| Labetalol Hydrochloride 100 mg 58657-0602-01 | Method | 100 tablets | $0.084 | AB | Availability likely | — |
| Labetalol Hydrochloride 100 mg 58657-0906-01 | Method | 1 tablet | $0.084 | AB | Availability likely | — |
| Labetalol Hydrochloride 100 mg 60687-0439-01 | American | 1 tablet | $0.084 | AB | Availability likely | — |
| Labetalol Hydrochloride 100 mgthis 62135-0791-60 | Chartwell | 60 tablets | $0.084 | AB | Availability likely | — |
| Labetalol Hydrochloride 100 mg 68001-0381-00 | BluePoint | 100 tablets | $0.084 | AB | Availability likely | — |
| Labetalol Hydrochloride 100 mg 68001-0700-00 | BluePoint | 100 tablets | $0.084 | AB | Availability likely | — |
| Labetalol Hydrochloride 100 mg 68382-0798-01 | Zydus | 100 tablets | $0.084 | AB | Availability likely | — |
| Labetalol Hydrochloride 100 mg 72603-0902-01 | NorthStar | 100 tablets | $0.084 | AB | Availability likely | — |
| Labetalol Hydrochloride 100 mg 72888-0120-01 | Advagen | 100 tablets | $0.084 | AB | Availability likely | — |
| Labetalol Hydrochloride 100 mg 00615-8512-39 | NCS | 30 tablets | — | AB | FDA listed | — |
| Labetalol Hydrochloride 100 mg 10135-0711-01 | Marlex | 100 tablets | — | AB | FDA listed | — |
| Labetalol Hydrochloride 100 mg 29300-0252-01 | Unichem | 100 tablets | — | — | FDA listed | — |
| Labetalol Hydrochloride 100 mg 33342-0515-11 | Macleods | 100 tablets | — | AB | FDA listed | — |
| Labetalol Hydrochloride 100 mg 42806-0327-01 | Epic | 100 tablets | — | AB | FDA listed | — |
| Labetalol Hydrochloride 100 mg 50090-6741-00 | A-S | 60 tablets | — | AB | FDA listed | — |
| Labetalol Hydrochloride 100 mg 50090-7457-00 | A-S | 60 tablets | — | AB | FDA listed | — |
| Labetalol Hydrochloride 100 mg 50090-7458-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Labetalol Hydrochloride 100 mg 51407-0614-01 | Golden | 100 tablets | — | AB | FDA listed | — |
| Labetalol Hydrochloride 100 mg 51655-0322-25 | Northwind | 60 tablets | — | AB | FDA listed | — |
| Labetalol Hydrochloride 100 mg 55154-0181-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Labetalol Hydrochloride 100 mg 55154-8192-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| Labetalol Hydrochloride 100 mg 60760-0784-90 | St. | 90 tablets | — | AB | FDA listed | — |
| Labetalol Hydrochloride 100 mg 60760-0991-90 | St. | 90 tablets | — | AB | FDA listed | — |
| Labetalol Hydrochloride 100 mg 63629-1161-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Labetalol Hydrochloride 100 mg 63629-1162-01 | Bryant | 500 tablets | — | AB | FDA listed | — |
| Labetalol Hydrochloride 100 mg 67296-2156-01 | Redpharm | 15 tablets | — | AB | FDA listed | — |
| Labetalol Hydrochloride 100 mg 70377-0060-11 | Biocon | 30 tablets | — | AB | FDA listed | — |
| Labetalol Hydrochloride 100 mg 70518-3499-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Labetalol Hydrochloride 100 mg 70518-4201-00 | REMEDYREPACK | 180 tablets | — | AB | FDA listed | — |
| Labetalol Hydrochloride 100 mg 70771-1163-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Labetalol hydrochloride 100 mg 71205-0095-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Labetalol Hydrochloride 100 mg 71209-0083-03 | Cadila | 60 tablets | — | AB | FDA listed | — |
| Labetalol HCL 100 mg 71335-2145-01 | Bryant | 30 tablets | — | — | Discontinued | — |
| Labetalol Hydrochloride 100 mg 71335-2475-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Labetalol Hydrochloride 100 mg 71335-3065-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Labetalol Hydrochloride 100 mg 72162-1675-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Labetalol Hydrochloride 100 mg 82804-0289-90 | Proficient | 90 tablets | — | AB | FDA listed | — |
| Labetalol Hydrochloride 100 mg 67046-1693-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 62135-0791-60 You're viewing this | 60 TABLET in 1 BOTTLE (62135-791-60) | 2023-10-24 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Labetalol HCl tablets are indicated in the management of hypertension. Labetalol HCl tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION DOSAGE MUST BE INDIVIDUALIZED. The recommended initial dosage is 100 mg twice daily whether used alone or added to a diuretic regimen. After 2 or 3 days, using standing blood pressure as an indicator, dosage may be titrated in increments of 100 mg b.i.d. every 2 or 3 days.
The usual maintenance dosage of labetalol HCl is between 200 and 400 mg twice daily. Since the full antihypertensive effect of labetalol HCl is usually seen within the first 1 to 3 hours of the initial dose or dose increment, the assurance of a lack of an exaggerated hypotensive response can be clinically established in the office setting. The antihypertensive effects of continued dosing can be measured at subsequent visits, approximately 12 hours after a dose, to determine whether further titration is necessary.
Patients with severe hypertension may require from 1,200 mg to 2,400 mg per day, with or without thiazide diuretics. Should side effects (principally nausea or dizziness) occur with these doses administered twice daily, the same total daily dose administered three times daily may improve tolerability and facilitate further titration. Titration increments should not exceed 200 mg twice daily.
When a diuretic is added, an additive antihypertensive effect can be expected. In some cases this may necessitate a labetalol HCl dosage adjustment. As with most antihypertensive drugs, optimal dosages of labetalol HCl tablets are usually lower in patients also receiving a diuretic.
When transferring patients from other antihypertensive drugs, labetalol HCl tablets should be introduced as recommended and the dosage of the existing therapy progressively decreased. Elderly Patients As in the general patient population, labetalol therapy may be initiated at 100 mg twice daily and titrated upwards in increments of 100 mg b.i.d. as required for control of blood pressure. Since some elderly patients eliminate labetalol more slowly, however, adequate control of blood pressure may be achieved at a lower maintenance dosage compared to the general population.
The majority of elderly patients will require between 100 and 200 mg b.i.d.
⛔ Contraindications ▾
CONTRAINDICATIONS Labetalol HCl tablets are contraindicated in bronchial asthma, overt cardiac failure, greater-than-first-degree heart block, cardiogenic shock, severe bradycardia, other conditions associated with severe and prolonged hypotension, and in patients with a history of hypersensitivity to any component of the product (see WARNINGS ). Beta-blockers, even those with apparent cardioselectivity, should not be used in patients with a history of obstructive airway disease, including asthma.
⚠️ Warnings ▾
WARNINGS Hepatic Injury Severe hepatocellular injury, confirmed by rechallenge in at least one case, occurs rarely with labetalol therapy. The hepatic injury is usually reversible, but hepatic necrosis and death have been reported. Injury has occurred after both short- and long-term treatment and may be slowly progressive despite minimal symptomatology.
Similar hepatic events have been reported with a related research compound, dilevalol HCl, including two deaths. Dilevalol HCl is one of the four isomers of labetalol HCl. Thus, for patients taking labetalol, periodic determination of suitable hepatic laboratory tests would be appropriate.
Appropriate laboratory testing should be done at the first symptom/sign of liver dysfunction (e.g., pruritus, dark urine, persistent anorexia, jaundice, right upper quadrant tenderness, or unexplained "flu-like" symptoms). If the patient has laboratory evidence of liver injury or jaundice, labetalol should be stopped and not restarted. Cardiac Failure Sympathetic stimulation is a vital component supporting circulatory function in congestive heart failure.
Beta-blockade carries a potential hazard of further depressing myocardial contractility and precipitating more severe failure. Although beta-blockers should be avoided in overt congestive heart failure, if necessary, labetalol HCl can be used with caution in patients with a history of heart failure who are well compensated. Congestive heart failure has been observed in patients receiving labetalol HCl.
Labetalol HCl does not abolish the inotropic action of digitalis on heart muscle. In Patients Without a History of Cardiac Failure In patients with latent cardiac insufficiency, continued depression of the myocardium with beta- blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of impending cardiac failure, patients should be fully digitalized and/or be given a diuretic, and the response should be observed closely.
If cardiac failure continues despite adequate digitalization and diuretic, therapy with labetalol HCl tablets should be withdrawn (gradually, if possible). Exacerbation of Ischemic Heart Disease Following Abrupt Withdrawal Angina pectoris has not been reported upon labetalol HCl discontinuation. However, hypersensitivity to catecholamines has been observed in patients withdrawn from beta-blocker therapy; exacerbation of angina and, in some cases, myocardial infarction have occurred after abrupt discontinuation of such therapy.
When discontinuing chronically administered labetalol HCl tablets, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of 1 to 2 weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, therapy with labetalol HCl tablets should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician's advice.
Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue therapy with labetalol HCl tablets abruptly in patients being treated for hypertension. Nonallergic Bronchospasm (e.g., Chronic Bronchitis and Emphysema) Patients with bronchospastic disease should, in general, not receive beta-blockers. Labetalol may be used with caution, however, in patients who do not respond to, or cannot tolerate, other antihypertensive agents.
It is prudent, if labetalol HCl tablets are used, to use the smallest effective dose, so that inhibition of endogenous or exogenous beta-agonists is minimized. Pheochromocytoma Labetalol HCl has been shown to be effective in lowering blood pressure and relieving symptoms in patients with pheochromocytoma. However, paradoxical hypertensive responses have been reported in a few patients with this tumor; there…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Most adverse effects are mild and transient and occur early in the course of treatment. In controlled clinical trials of 3 to 4 months' duration, discontinuation of labetalol HCl tablets due to one or more adverse effects was required in 7% of all patients. In these same trials, other agents with solely beta-blocking activity used in the control groups led to discontinuation in 8% to 10% of patients, and a centrally acting alpha-agonist led to discontinuation in 30% of patients.
The incidence rates of adverse reactions listed in the following table were derived from multicenter, controlled clinical trials comparing labetalol HCl, placebo, metoprolol, and propranolol over treatment periods of 3 and 4 months. Where the frequency of adverse effects for labetalol HCl and placebo is similar, causal relationship is uncertain. The rates are based on adverse reactions considered probably drug related by the investigator.
If all reports are considered, the rates are somewhat higher (e.g., dizziness, 20%, nausea, 14%, fatigue, 11%), but the overall conclusions are unchanged. Labetalol HCl (n= 227) % Placebo (n= 98) % Propranolol (n= 84) % Metoprolol (n= 49) % Body as a whole Fatigue 5 0 12 12 Asthenia 1 1 1 0 Headache 2 1 1 2 Gastrointestinal Nausea 6 1 1 2 Vomiting <1 0 0 0 Dyspepsia 3 1 1 0 Abdominal pain 0 0 1 2 Diarrhea <1 0 2 0 Taste distortion 1 0 0 0 Central and Peripheral Nervous Systems Dizziness 11 3 4 4 Paresthesias <1 0 0 0 Drowsiness <1 2 2 2 Autonomic Nervous System Nasal stuffiness 3 0 0 0 Ejaculation failure 2 0 0 0 Impotence 1 0 1 3 Increased sweating <1 0 0 0 Cardiovascular Edema 1 0 0 0 Postural hypotension 1 0 0 0 Bradycardia 0 0 5 12 Respiratory Dyspnea 2 0 1 2 Skin Rash 1 0 0 0 Special Senses Vision abnormality 1 0 0 0 Vertigo 2 1 0 0 The adverse effects were reported spontaneously and are representative of the incidence of adverse effects that may be observed in a properly selected hypertensive patient population, i.e., a group excluding patients with bronchospastic disease, overt congestive heart failure, or other contraindications to beta-blocker therapy.
Clinical trials also included studies utilizing daily doses up to 2,400 mg in more severely hypertensive patients. Certain of the side effects increased with increasing dose, as shown in the following table that depicts the entire U.S. therapeutic trials data base for adverse reactions that are clearly or possibly dose related. Labetalol HCl Daily Dose (mg) 200 300 400 600 800 Number of patients 522 181 606 608 503 Dizziness (%) 2 3 3 3 5 Fatigue 2 1 4 4 5 Nausea <1 0 1 2 4 Vomiting 0 0 <1 <1 <1 Dyspepsia 1 0 2 1 1 Paresthesia 2 0 2 2 1 Nasal stuffiness 1 1 2 2 2 Ejaculation failure 0 2 1 2 3 Impotence 1 1 1 1 2 Edema 1 0 1 1 1 Labetalol HCl Daily Dose (mg) 900 1,200 1,600 2,400 Number of patients 117 411 242 175 Dizziness (%) 1 9 13 16 Fatigue 3 7 6 10 Nausea 0 7 11 19 Vomiting 0 1 2 3 Dyspepsia 0 2 2 4 Paresthesia 1 2 5 5 Nasal stuffiness 2 4 5 6 Ejaculation failure 0 4 3 5 Impotence 4 3 4 3 Edema 0 1 2 2 In addition, a number of other less common adverse events have been reported: Body as a Whole Fever.
Cardiovascular Hypotension, and rarely, syncope, bradycardia, heart block. Central and Peripheral Nervous Systems Paresthesia, most frequently described as scalp tingling. In most cases, it was mild and transient and usually occurred at the beginning of treatment.
Collagen Disorders Systemic lupus erythematosus, positive antinuclear factor. Eyes Dry eyes. Immunological System Antimitochondrial antibodies.
Liver and Biliary System Hepatic necrosis, hepatitis, cholestatic jaundice, elevated liver function tests. Musculoskeletal System Muscle cramps, toxic myopathy. Respiratory System Bronchospasm.
Skin and Appendages Rashes of various types, such as generalized maculopapular, lichenoid, urticarial, bullous lichen planus, psoriaform, and facial erythema; Peyronie's disease; reversible alopecia. Urinary System Difficulty in micturition, includin…
🆘 Overdosage ▾
OVERDOSAGE Overdosage with labetalol HCl causes excessive hypotension that is posture sensitive and, sometimes, excessive bradycardia. Patients should be placed supine and their legs raised if necessary to improve the blood supply to the brain. If overdosage with labetalol HCl follows oral ingestion, gastric lavage or pharmacologically induced emesis (using syrup of ipecac) may be useful for removal of the drug shortly after ingestion.
The following additional measures should be employed if necessary: Excessive bradycardia - administer atropine or epinephrine. Cardiac failure - administer a digitalis glycoside and a diuretic. Dopamine or dobutamine may also be useful.
Hypotension - administer vasopressors, e.g., norepinephrine. There is pharmacological evidence that norepinephrine may be the drug of choice. Bronchospasm - administer epinephrine and/or an aerosolized beta2-agonist.
Seizures - administer diazepam. In severe beta-blocker overdose resulting in hypotension and/or bradycardia, glucagon has been shown to be effective when administered in large doses (5 to 10 mg rapidly over 30 seconds, followed by continuous infusion of 5 mg per hour that can be reduced as the patient improves). Neither hemodialysis nor peritoneal dialysis removes a significant amount of labetalol HCl from the general circulation (< 1%).
The oral LD 50 value of labetalol HCl in the mouse is approximately 600 mg/kg and in the rat is > 2 g/kg. The IV LD 50 in these species is 50 to 60 mg/kg.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Labetalol HCl combines both selective, competitive, alpha 1 -adrenergic blocking and nonselective, competitive beta-adrenergic blocking activity in a single substance. In man, the ratios of alpha- to beta-blockade have been estimated to be approximately 1:3 and 1:7 following oral and intravenous (IV) administration, respectively. Beta 2 -agonist activity has been demonstrated in animals with minimal beta 1 -agonist (ISA) activity detected.
In animals, at doses greater than those required for alpha- or beta-adrenergic blockade, a membrane stabilizing effect has been demonstrated.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Labetalol Hydrochloride Tablets, USP are available as follows: 100 mg tablets: Yellow, round, bevel-edged, film-coated tablets, debossed 723 on one side and bisect on the other side. They are available as follows: Bottle of 60 tablets NDC 62135-791-60 200 mg tablets: White, round, bevel-edged, film-coated tablets, debossed 724 on one side and bisect on the other side. They are available as follows: Bottle of 60 tablets NDC 62135-792-60 300 mg tablets: Green, round, bevel-edged, film-coated tablets, debossed 725 on one side and plain on the other side.
They are available as follows: Bottle of 60 tablets NDC 62135-800-60 Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71780 Rev. 10/2023
📋 Description ▾
DESCRIPTION Labetalol Hydrochloride Tablets, USP are adrenergic receptor blocking agents that have both selective alpha 1 -adrenergic and non-selective beta-adrenergic receptor blocking actions in a single substance. Labetalol HCl, USP is a racemate, chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] salicylamide monohydrochloride, and it has the following structural formula: Labetalol HCl, USP has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs.
Dilevalol, the R, R' stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl, USP is a white or off-white crystalline powder, soluble in water. Each tablet, for oral administration, contains 100 mg, 200 mg, or 300 mg of Labetalol Hydrochloride USP.
In addition, each tablet contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, methocel, purified water, sodium starch glycolate and colorants (100 mg: Opadry yellow YS-1-12630; 200 mg: Opadry White YS-1-7003; 300 mg: Opadry Green YS-1-3256). labetalol-structure