Medicine guide

Labetalol Hydrochloride

100 mg · Tablet, Film Coated

Prescription only
beta-Adrenergic Blocker

Active substance: Labetalol Hydrochloride
Used in: Heart, blood pressure and circulation
Made by: Zydus Pharmaceuticals USA Inc.
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-03-02

What it is

beta-Adrenergic Blocker

Used for

Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially…

The label’s usual adult dose

The recommended initial dose is 100 mg twice daily whether used alone or added to a diuretic regimen.

Full directions ↓

Do not take it if

Labetalol hydrochloride 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…

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

94other products contain Labetalol Hydrochloride — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.

From the official label · 2026-03-02 · DailyMed

How it works

From this product’s own US prescribing label.

Labetalol hydrochloride 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.

Peak level after1–2 h

Half-life6–8 h

Mostly cleared after≈ 35 hfive half-lives — our arithmetic

The shape is a standard model drawn from the two times above, not a measurement. How fast a medicine acts and wears off also depends on the dose, the form and the person.

How it leaves the body

These metabolites are present in plasma and are excreted in the urine and, via the bile, into the feces.

With food

The absolute bioavailability of labetalol is increased when administered with food.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-03-02

Do not take it if

Labetalol hydrochloride 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 cardio selectivity, should not be used in patients with a history of obstructive airway disease, including asthma.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

DOSAGE MUST BE INDIVIDUALIZED.
The recommended initial dose 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 hydrochloride tablets is between 200 mg and 400 mg twice daily.
Since the full antihypertensive effect of labetalol hydrochloride tablets is usually seen within the first 1to 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 1200 mg to 2400 mg per day, with or without thiazide diuretics.
Should side effects (principally nausea or dizziness) occur with these doses administered b.i.d.(twice daily), the same total daily dose administered t.i.d.
(three times daily) may improve tolerability and facilitate further titration.
Titration increments should not exceed 200 mg b.i.d.(twice daily).
When a diuretic is added, an additive antihypertensive effect can be expected.
In some cases this may necessitate a labetalol hydrochloride tablet dosage adjustment.
As with most antihypertensive drugs, optimal dosages of labetalol hydrochloride tablets are usually lower in patients also receiving a diuretic.
When transferring a patient from other antihypertensive drugs, labetalol hydrochloride 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 mg and 200 mg b.i.d.

Quoted from the official label, section “Dosage & Administration”.

Other 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 hydrochloride, including two deaths.
Dilevalol hydrochloride is one of the four isomers of labetalol hydrochloride.
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 or 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 hydrochloride 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 hydrochloride.
Labetalol hydrochloride 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 hydrochloride tablets should be withdrawn (gradually, if possible).
Exacerbation of Ischemic Heart Disease Following Abrupt Withdrawal Angina pectoris has not been reported upon labetalol hydrochloride 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 hydrochloride 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, labetalol hydrochloride tablet administration 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 hydrochloride tablets abruptly in patients being treated for hypertension.
Non allergic bronchospasm (e.g. chronic bronchitis and emphysema) patients with bronchospastic disease should, in general, not receive beta-blockers .
Labetalol hydrochloride tablets may be used with caution, however, in patients who do not respond to, or cannot tolerate, other antihypertensive agents.
It is prudent, if labetalol hydrochloride tablets are used, to use
the smallest effective dose, so that inhibition of endogenous or exogenous beta-agonists is minimized.
Pheochromocytoma Labetalol hydrochloride 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; therefore, use caution when administering labetalol hydrochloride to patients with pheochromocytoma.
Hypoglycemia Beta-blockers may prevent early warning signs of hypoglycemia, such as tachycardia, and increase the risk for severe or prolonged hypoglycemia at any time during treatment, especially in patients with diabetes mellitus or children and patients who are fasting (i.e., surgery, not eating regularly, or are vomiting).
If severe hypoglycemia occurs, patients should be instructed to seek emergency treatment.
Major Surgery The necessity or desirability of withdrawing beta-blocking therapy before major surgery is controversial.
Protracted severe hypotension and difficulty in restarting or maintaining a heartbeat have been reported with beta-blockers.
The effect of labetalol hydrochloride's alpha-adrenergic activity has not been evaluated in this setting.
A synergism between labetalol hydrochloride and halothane anesthesia has been shown (see PRECAUTIONS , Drug Interactions ).
General Impaired Hepatic Function Labetalol hydrochloride tablets should be used with caution in patients with impaired hepatic function since metabolism of the drug may be diminished. Jaundice or Hepatic Dysfunction (see WARNINGS ).

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Teratogenic Effects Pregnancy Category C Teratogenic studies were performed with labetalol in rats and rabbits at oral doses up to approximately six and four times the maximum recommended human dose (MRHD), respectively.
No reproducible evidence of fetal malformations was observed.
Increased fetal resorptions were seen in both species at doses approximating the MRHD.
A teratology study performed with labetalol in rabbits at intravenous doses up to 1.7 times the MRHD revealed no evidence of drug-related harm to the fetus.
There are no adequate and well-controlled studies in pregnant women.
Labetalol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effects Hypotension, bradycardia, hypoglycemia and respiratory depression have been reported in infants of mothers who were treated with labetalol hydrochloride for hypertension during pregnancy.
Oral administration of labetalol to rats during late gestation through weaning at doses of two to four times the MRHD caused a decrease in neonatal survival.
Small amounts of labetalol (approximately 0.004% of the maternal dose) are excreted in human milk. Caution should be exercised when labetalol hydrochloride tablets are administered to a nursing woman..

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

In one survey, 2.3% of patients taking labetalol hydrochloride in combination with tricyclic antidepressants experienced tremor as compared to 0.7% reported to occur with labetalol hydrochloride alone.
The contribution of each of the treatments to this adverse reaction is unknown but the possibility of a drug interaction cannot be excluded.
Drugs possessing beta-blocking properties can blunt the bronchodilator effect of beta-receptor agonist drugs in patients with bronchospasm; therefore, doses greater than the normal anti-asthmatic dose of beta-agonist bronchodilator drugs may be required.
Cimetidine has been shown to increase the bioavailability of labetalol hydrochloride.
Since this could be explained either by enhanced absorption or by an alteration of hepatic metabolism of labetalol hydrochloride, special care should be used in establishing the dose required for blood pressure control in such patients.
Synergism has been shown between halothane anesthesia and intravenously administered labetalol hydrochloride.
During controlled hypotensive anesthesia using labetalol hydrochloride in association with halothane, high concentrations (3% or above) of halothane should not be used because the degree of hypotension will be increased and because of the possibility of a large reduction in cardiac output and an increase in central venous pressure.
The anesthesiologist should be informed when a patient is receiving labetalol hydrochloride.
Labetalol hydrochloride blunts the reflex tachycardia produced by nitroglycerin without preventing its hypotensive effect.
If labetalol hydrochloride is used with nitroglycerin in patients with angina pectoris, additional antihypertensive effects may occur.
Care should be taken if labetalol is used concomitantly with calcium antagonists of the verapamil type.
Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate.
Concomitant use can increase the risk of bradycardia.
Risk of Anaphylactic Reaction While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic or therapeutic.
Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.
Drug/Laboratory Test Interactions The presence of labetalol metabolites in the urine may result in falsely elevated levels of urinary catecholamines, metanephrine, normetanephrine and vanillylmandelic acid (VMA) when measured by fluorimetric or photometric methods.
In screening patients suspected of having a pheochromocytoma and being treated with labetalol hydrochloride, a specific method, such as a high performance liquid chromatographic assay with solid phase extraction (e.g.
J.
Chromatogr 385:241, 1987) should be employed in determining levels of catecholamines.
Labetalol hydrochloride has also been reported to produce a false-positive test for amphetamine when screening urine for the presence of drugs using the commercially available assay methods Toxi-LabA ® (thin-layer chromatographic assay) and Emit-d.a.u. ® (radioenzymatic assay).
When patients being treated with labetalol have a positive urine test for amphetamine using these techniques, confirmation should be made by using more specific methods, such as a gas chromatographic-mass spectrometer technique.
Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term oral dosing studies with labetalol hydrochloride for 18 months in mice and for 2 years in rats showed no evidence of carcinogenesis.
Studies with labetalol hydrochloride using dominant lethal assays in rats and mice and exposing microorganisms according to modified Ames tests, showed no evidence of mutagenesis.
Pregnancy Teratogenic Effects Pregnancy Category C Teratogenic studies were performed with labetalol in rats and rabbits at oral doses up to approximately six and four times the maximum recommended human dose (MRHD), respectively.
No reproducible evidence of fetal malformations was observed.
Increased fetal resorptions were seen in both species at doses approximating the MRHD.
A teratology study performed with labetalol in rabbits at intravenous doses up to 1.7 times the MRHD revealed no evidence of drug-related harm to the fetus.
There are no adequate and well-controlled studies in pregnant women.
Labetalol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effects Hypotension, bradycardia, hypoglycemia and respiratory depression have been reported in infants of mothers who were treated with labetalol hydrochloride for hypertension during pregnancy.
Oral administration of labetalol to rats during late gestation through weaning at doses of two to four times the MRHD caused a decrease in neonatal survival.
Labor and Delivery Labetalol hydrochloride given to pregnant women with hypertension did not appear to affect the usual course of labor and delivery.
Nursing Mothers Small amounts of labetalol (approximately 0.004% of the maternal dose) are excreted in human milk.
Caution should be exercised when labetalol hydrochloride tablets are administered to a nursing woman..
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Elderly Patients As in the general population, some elderly patients (60 years of age and older) have experienced orthostatic hypotension, dizziness or lightheadedness during treatment with labetalol.
Because elderly patients are generally more likely than younger patients to experience orthostatic symptoms, they should be cautioned about the possibility of such side effects during treatment with labetalol.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Overdosage with labetalol hydrochloride 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 hydrochloride 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 mg to 10 mg rapidly over 30 seconds, followed by continuous infusion of 5 mg/hr that can be reduced as the patient improves).
Neither hemodialysis nor peritoneal dialysis removes a significant amount of labetalol hydrochloride from the general circulation (<1%).
The oral LD 50 value of labetalol hydrochloride in the mouse is approximately 600 mg/kg and in the rat is greater than 2 g/kg.
The intravenous LD 50 in these species is 50 mg/kg to 60 mg/kg.

Quoted from the official label, section “Overdosage”.

Use in children

Safety and effectiveness in pediatric patients have not been established.

Quoted from the official label, section “Pediatric Use”.

Side effects

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 hydrochloride 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 acentrally 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 hydrochloride, placebo, metoprolol and propranolol, over treatment periods of 3 and 4 months.
Where the frequency of adverse effects for labetalol hydrochloride 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 Hydrochloride (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 table below which depicts the entire U.S. therapeutic trials data base for adverse reactions that are clearly or possibly dose related.
Labetalol Hydrochloride DailyDose(mg) 200 300 400 600 800 900 1200 1600 2400 Number of Patients 522 181 606 608 503 117 411 242 175 Dizziness (%) 2 3 3 3 5 1 9 13 16 Fatigue 2 1 4 4 5 3 7 6 10 Nausea <1 0 1 2 4 0 7 11 19 Vomiting 0 0 <1 <1 <1 0 1 2 3 Dyspepsia 1 0 2 1 1 0 2 2 4 Paresthesias 2 0 2 2 1 1 2 5 5 Nasal Stuffiness 1 1 2 2 2 2 4 5 6 Ejaculation Failure 0 2 1 2 3 0 4 3 5 Impotence 1 1 1 1 2 4 3 4 3 Edema 1 0 1 1 1 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 (ANF).
Eyes : Dry eyes.
Immunological System : Anti mitochondrial 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; facial erythema;
Peyronie's disease, reversible alopecia.
Urinary System : Difficulty in micturition, including acute urinary bladder retention..
Hypersensitivity :
Rare reports of hypersensitivity (e.g. rash, urticaria, pruritus, angioedema, dyspnea) and anaphylactoid reactions.
Following approval for marketing in the United Kingdom, a monitored release survey involving approximately 6,800 patients was conducted for further safety and efficacy evaluation of this product.
Results of this survey indicate that the type, severity and incidence of adverse effects were comparable to those cited above.
Potential Adverse Effects In addition, other adverse effects not listed above have been reported with other beta-adrenergic blocking agents.
Central Nervous System :
Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium and decreased performance on psychometrics.
Cardiovascular : Intensification of A-V block (see CONTRAINDICATIONS).
Allergic :
Fever combined with aching and sore throat; laryngospasm; respiratory distress.
Hematologic: Agranulocytosis; thrombocytopenic or non thrombocytopenic purpura.
Gastrointestinal : Mesenteric artery thrombosis; ischemic colitis.
The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with labetalol hydrochloride.
Clinical Laboratory Tests There have been reversible increases of serum transaminases in 4% of patients treated with labetalol hydrochloride and tested, and more rarely, reversible increases in blood urea.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

As with all drugs with beta-blocking activity, certain advice to patients being treated with labetalol hydrochloride is warranted.
This information is intended to aid in the safe and effective use of this medication.
It is not a disclosure of all possible adverse or intended effects.
While no incident of the abrupt withdrawal phenomenon (exacerbation of angina pectoris) has been reported with labetalol hydrochloride, dosing with labetalol hydrochloride tablets should not be interrupted or discontinued without a physician's advice.
Patients being treated with labetalol hydrochloride tablets should consult a physician at any signs or symptoms of impending cardiac failure or hepatic dysfunction (see WARNINGS ).
Also, transient scalp tingling may occur, usually when treatment with labetalol hydrochloride tablets is initiated (see ADVERSE REACTIONS ).
Inform patients or caregivers that there is a risk of hypoglycemia when labetalol hydrochloride tablets are given to patients who are fasting or who are vomiting.
Monitor for symptoms of hypoglycemia (see WARNINGS ).
Laboratory Tests As with any new drug given over prolonged periods, laboratory parameters should be observed over regular intervals.
In patients with concomitant illnesses, such as impaired renal function, appropriate tests should be done to monitor these conditions.

Quoted from the official label, section “Patient Counseling Information”.

What it looks like and how it is packed

Labetalol Hydrochloride Tablets USP for oral administration are available as:
Labetalol Hydrochloride Tablets USP, 100 mg are yellow colored, round, biconvex, film-coated tablets debossed with "7" and "98" on either side of score line on one side and plain on other side and are supplied as:
NDC 68382-798-06 in bottle of 30 tablets NDC 68382-798-16 in bottle of 90 tablets NDC 68382-798-01 in bottle of 100 tablets NDC 68382-798-05 in bottle of 500 tablets Labetalol Hydrochloride Tablets USP, 200 mg are white to off white colored, round, biconvex, film-coated tablets debossed with "7" and "99" on either side of score line on one side and plain on other side and are supplied as:
NDC 68382-799-06 in bottle of 30 tablets NDC 68382-799-16 in bottle of 90 tablets NDC 68382-799-01 in bottle of 100 tablets NDC 68382-799-05 in bottle of 500 tablets Labetalol Hydrochloride Tablets USP, 300 mg are light green colored, round, biconvex, beveled edge, film-coated tablets debossed with "800" on one side and plain on other side and are supplied as:
NDC 68382-800-06 in bottle of 30 tablets NDC 68382-800-16 in bottle of 90 tablets NDC 68382-800-01 in bottle of 100 tablets NDC 68382-800-05 in bottle of 500 tablets Labetalol Hydrochloride Tablets USP should be Stored at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required.
To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals USA Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
This product's package insert may have been updated.
For current package insert, please visit www.zydususa.com Manufactured by:
Zydus Lifesciences Ltd.
Matoda, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc.
Pennington, NJ 08534 Rev.: 03/26

Quoted from the official label, section “How Supplied”.

What is in it

Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective Alpha 1 -adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl- 3-phenylpropyl)amino]ethyl]benzamide mono hydrochloride and it has the following structure:
Labetalol hydrochloride has the molecular formula C19 H24 N2 O3
HCl and a molecular weight of 364.87. It 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 hydrochloride, USP is a white or almost white powder. It is sparingly soluble in water and in ethanol (96%), practically insoluble in ether and in methylene chloride. Labetalol hydrochloride tablet, USP for oral administration contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients:
corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium starch glycolate (botanical source:
potato) and titanium dioxide. Additionally, 100 mg tablets contain D&C yellow #10 Aluminum lake, iron oxide yellow, iron oxide red and talc. 300 mg tablets contain FD&C blue #1 Aluminum lake, iron oxide yellow and talc. Labetalol hydrochloride tablets

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Lactoselactose monohydrateMilk sugar: matters with lactose intolerance or a milk allergy.
Colour dyes100 mg tablets contain D&C yellow #10 Aluminum lake; talc. 300 mg tablets contain FD&C blue #1 Aluminum lakeSome people react to dyes such as tartrazine (Yellow 5) or carmine.
Titanium dioxidetitanium dioxideA whitening agent no longer allowed in food in the EU (E171).

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

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Details

Made by	Zydus Pharmaceuticals USA Inc.
Active substance	Labetalol Hydrochloride
Used in	Heart, blood pressure and circulation
Strength	100 mg
Form	Tablet, Film Coated
Route	Oral
Packs	100 TABLET, FILM COATED in 1 BOTTLE · 500 TABLET, FILM COATED in 1 BOTTLE
NDC	68382-798

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

95 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Tablet, Film Coated63 products
- 100 mg24
  100 mg · 24 companies
  +16 more
- 200 mg20
  200 mg · 20 companies
  +12 more
- 300 mg18
  300 mg · 18 companies
  +10 more
- 400 mg
Tablet17 products
- 100 mg6
  100 mg · 6 companies
- 200 mg5
  200 mg · 5 companies
- 300 mg5
  300 mg · 5 companies
- 400 mg
Injection, Solution9 products
- 5 mg/mL9
  5 mg/mL · 9 companies
  +1 more
Injection6 products
- 5 mg/mL4
  5 mg/mL · 4 companies
- 100 mg/20mL
- 200 mg/40mL

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Labetalol Hydrochloride