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Labetalol Hydrochloride 100 mg Tablet, Film Coated, 100-count

by Innogenix, Inc. · 100 TABLET, FILM COATED in 1 BOTTLE (71247-126-01)

NDC 71247-0126-01

🏷️ FDA NDC (as labeled) 71247-126-01 billing pads the product segment with a zero

This package

Contains100-count Cost per ea$0.0830 NADAC Per package$8.30 / 100 tablets Pack sizes2 compare ↓

Also priced by: Medicaid pays $0.2464/unit · Part D plans $0.1818/unit — full pricing hub ↓

Also comes in: 500 tablets 71247-0126-05

Rx only Generic On market Non-controlled

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️

Other active recalls for Labetalol Hydrochloride (different manufacturers) — 1 · tap to view

These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.

Class II · May 20, 2024 — Lack of Assurance of Sterility-The potential for incomplete crimp seals. (Pfizer Inc.) · FDA recall D-0565-2024

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 71247-126-01

Product NDC 71247-126

11-digit billing NDC 71247012601

NCPDP billing unit EA — each (per item)

RxCUI 896758, 896762, 896766

UNII 1GEV3BAW9J

UPC 0371247126014, 0371247127011, 0371247130011

Application # ANDA075215

SPL Set ID 82fc2d64-0572-4a9b-94fc-f6eb8d930c54

Established class (EPC) beta-Adrenergic Blocker

Mechanism of action Adrenergic beta-Antagonists

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2021-02-08

Route ORAL

Dosage form TABLET, FILM COATED

Substance LABETALOL HYDROCHLORIDE

GPI-14 33300010100305

GPI class Labetalol HCl

GCN Seq No 005098

GCN 10342

HICL code 002095

Ingredient (HICL) Labetalol Hcl

HIC1 code J

Therapeutic class — broad (HIC1) Autonomic Nervous System

HIC2 code J7

Therapeutic class — intermediate (HIC2) Antiadrenergics

HIC3 code J7A

Therapeutic class — specific (HIC3) Alpha/Beta-Adrenergic Blocking Agents

AHFS code 12:16.04.12

AHFS class Selective Alpha-1-Adrenergic Block.agent

FDB label name LABETALOL HCL 100 MG TABLET

FDB brand name Labetalol Hcl

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 71247-126-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 71247-0126-01. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the beta-Adrenergic Blocker class.

Pharmacologic class beta-Adrenergic Blocker

Drug family (ATC) Alpha and beta blocking agents

How it works Adrenergic beta-Antagonists

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerInnogenix, Inc.

Application holderINNOGENIX LLC

FDA applicationANDA075215 (ANDA)

Labeler code71247

First marketedFeb 2021

Product typeHuman Prescription Drug

Portfolio9 products on file

🔎 All NDCs from Innogenix, Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name LABETALOL HCL 100 MG TABLET Ingredient Labetalol Hcl

📗 Our plain-language guide HelloPharmacist

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...

📖 Read our full Labetalol guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Nutrient depletion considerations

Labetalol may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

COENZYME Q10 Insufficient Evidence

🧪 Full Labetalol nutrient depletion report →

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color brown / white / blue

ShapeRound

ImprintI;130

Size11 mm

ScoringNot scored

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
UNII R12CBM0EIZ
A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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.
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.
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.
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.
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.
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.

10 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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	$0.083	$8.30 / 100 tablets
Medicaid paysCMS SDUD · 12 mo	$0.2464	$24.64 / 100 tablets
Medicare drug plans payPart D · Q2 2026	$0.1818	$18.18 / 100 tablets

NADAC price history (per ea) — tap or hover for the price & month

▼ Down 30% over the last 18 months.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Labetalol Hydrochloride 100 mgthis 71247-0126-01	Innogenix,	100 tablets	$0.083	AB	FDA listed	—
Labetalol hydrochloride 100 mg 00591-0605-01	Actavis	100 tablets	$0.085	AB	Availability likely	+2%
Labetalol Hydrochloride 100 mg 00904-7451-61	Major	1 tablet	$0.085	AB	Availability likely	+2%
Labetalol Hydrochloride 100 mg 23155-0723-01	Heritage	100 tablets	$0.085	AB	Availability likely	+2%
Labetalol Hydrochloride 100 mg 58657-0602-01	Method	100 tablets	$0.085	AB	Availability likely	+2%
Labetalol Hydrochloride 100 mg 58657-0906-01	Method	1 tablet	$0.085	AB	Availability likely	+2%
Labetalol Hydrochloride 100 mg 60687-0439-01	American	1 tablet	$0.085	AB	Availability likely	+2%
Labetalol Hydrochloride 100 mg 62135-0791-60	Chartwell	60 tablets	$0.085	AB	Availability likely	+2%
Labetalol Hydrochloride 100 mg 68001-0381-00	BluePoint	100 tablets	$0.085	AB	Availability likely	+2%
Labetalol Hydrochloride 100 mg 68001-0700-00	BluePoint	100 tablets	$0.085	AB	Availability likely	+2%
Labetalol Hydrochloride 100 mg 68382-0798-01	Zydus	100 tablets	$0.085	AB	Availability likely	+2%
Labetalol Hydrochloride 100 mg 72603-0902-01	NorthStar	100 tablets	$0.085	AB	Availability likely	+2%
Labetalol Hydrochloride 100 mg 72888-0120-01	Advagen	100 tablets	$0.085	AB	Availability likely	+2%
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	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2021

On the market since

Feb 2021

📍

2026

Currently FDA-listed

5 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

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?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 71247-0126-01, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

Units reimbursed last 4 qtrs

3.2K

Gross reimbursed last 4 qtrs

$788.49

Avg / prescription

$15.46

Avg / unit

$0.2464

Latest quarter Q4 2025

0Rx

Medicaid pays / ea

$0.2464

gross reimbursed

NADAC / ea

$0.0830

acquisition cost

Spread

+$0.1634

+197% vs cost

What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

73% FFS 27% MCO

Fee-for-service · 37 Rx Managed care · 14 Rx

State Medicaid map

Units reimbursed · per 100k residents

5.86.3

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 California 6.3 /100k

2 Pennsylvania 5.8 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

100 tablets this page71247-0126-01 51 Rx · $788

500 tablets71247-0126-05 No Medicaid data

Drug total (last 4 qtrs): 51 Rx · 3,200 units · $788 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Labetalol Hydrochloride — the ingredient across all brands.

Top reported reactions

Premature Baby142

Foetal Exposure During Pregnancy138

Fatigue121

Hypertension112

Nausea104

Diarrhoea94

Headache85

Age at onset

Neonate41

Infant2

Child1

Adolescent4

Adult207

Elderly149

Reporter sex

Male · 34%

Female · 66%

Unknown · 0%

Serious outcomes

Death180

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
71247-0126-01 You're viewing this	100 TABLET, FILM COATED in 1 BOTTLE (71247-126-01)	$0.0830 / ea	$8.30	2021-02-08	Active
71247-0126-05	500 TABLET, FILM COATED in 1 BOTTLE (71247-126-05)	$0.0830 / ea	$41.49	2021-02-08	Active

You're viewing the smallest of 2 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0830 NADAC).

Pack size FAQ

What quantity is in NDC 71247-0126-01?

NDC 71247-0126-01 is a 100-count package — 100 tablet, film coated in 1 bottle.

What is the difference between NDC 71247-0126-01 and NDC 71247-0126-05?

Both are Labetalol Hydrochloride 100 mg Tablet, Film Coated — the drug itself is identical. NDC 71247-0126-01 is the 100-count package, while NDC 71247-0126-05 is the 500 tablets package.

What NDC number is used to bill for this package of Labetalol Hydrochloride 100 mg Tablet, Film Coated?

Bill NDC 71247-0126-01 — the 11-digit billing format is 71247012601. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description

🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Labetalol Hydrochloride is indicated in the management of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including beta adrenergic blockers.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Labetalol Hydrochloride Tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.

Labetalol Hydrochloride Tablets are a beta adrenergic blocker indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1 )

⏱️ Dosage and Administration 217 words ▾

2 DOSAGE AND ADMINISTRATION The recommended initial dosage is 100 mg twice daily, alone or added to a diuretic regimen. Titrate in increments of 100 mg twice daily every 2 or 3 days. Maintenance dosage is between 200 and 400 mg twice daily.

( 2.1 ) Severe Hypertension: May require from 1,200 to 2,400mg per day, with or without thiazide diuretics. Titrate in increments not to exceed 200 mg twice daily. ( 2.2 ) Elderly patients: Initiate at 100 mg twice daily.

Titrate in increments of 100 mg twice daily as required for blood pressure control. Many elderly patients will require between 100 and 200 mg twice daily. ( 2.3 )

2.1Recommended Dosage Labetalol Hydrochloride dosage must be individualized. The recommended initial dosage of labetalol hydrochloride is 100 mg twice daily. Adjust dosage in increments of 100 mg twice daily at 2- to 3-day intervals based on response. The recommended maintenance dosage of labetalol hydrochloride is between 200 and 400 mg twice daily.

💊 Dosage Forms and Strengths 85 words ▾

3 DOSAGE FORMS AND STRENGTHS Labetalol Hydrochloride Tablets are available in the following strengths: 100 mg - Round, beige, film-coated tablets, plain on one side, scored and debossed with “I/126” on the other side. 200 mg - Round, white, film-coated tablets, plain on one side, scored and debossed with “I/127” on the other side. 300 mg - Round, blue, film-coated tablets, plain on one side and debossed with “I/130” on the other side.

Tablets: 100 mg, 200 mg, and 300 mg tablets ( 3 )

⛔ Contraindications 75 words ▾

4 CONTRAINDICATIONS Labetalol Hydrochloride Tablets are contraindicated in patients with: bronchial asthma or obstructive airway disease decompensated heart failure greater than first degree heart block cardiogenic shock severe bradycardia Hypersensitivity reactions, including anaphylaxis, to labetalol non-dihydropyridine calcium-channel antagonists Bronchial asthma or obstructive airway disease ( 4 ) Overt cardiac failure ( 4 ) Greater‑than‑first‑degree heart block ( 4 ) Cardiogenic shock ( 4 ) Severe bradycardia ( 4 ) Non-dihydropyridine calcium-channel antagonists ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Monitor patients for symptomatic postural hypotension and syncope after initial dosing or dose increments. ( 5.1 ) Monitor heart rate and rhythm for bradycardia, including sinus pause, heart block, severe bradycardia, and cardiac arrest in patients receiving Labetalol Hydrochloride Tablets. ( 5.2 ) Beta-blockade can depress myocardial contractility and precipitating more severe failure.

Avoid use in patients with overt heart failure. ( 5.3 ). Monitor heart rate and rhythm for bradycardia, including sinus pause, heart block, severe bradycardia, and cardiac arrest in patients receiving Labetalol Hydrochloride Tablets.

( 5.2 ) Beta-blockade can depress myocardial contractility and precipitating more severe failure. Avoid use in patients with overt heart failure. ( 5.3 ) Acute exacerbation of coronary artery disease upon cessation of therapy.

Do not abruptly discontinue. ( 5.4 ) Avoid use in patients with bronchospastic disease. ( 5.5 ) Beta‑adrenergic blockade may prevent the appearance of premonitory signs and symptoms (e.g., tachycardia) of acute hypoglycemia.

( 5.6 ) Exacerbation of pheochromocytoma: Paradoxical increases in blood pressure may occur. ( 5.7 ) Hepatic necrosis and death have been reported. If the patient develops signs or symptoms of liver injury, institute appropriate treatment and investigate the probable cause.

( 5.8 ) Do not routinely withdraw chronic beta blocker therapy prior to surgery. ( 5.10 )

5.1Hypotension Monitor patients for symptomatic postural hypotension and syncope after initial dosing or dose increments with Labetalol Hydrochloride Tablets. Elderly patients are generally more likely than younger patients to experience orthostatic symptoms [see Dosage and Administration (2.1) , Use in Specific Populations (8.5) , Clinical Pharmacology (12.2) ].

5.2Bradycardia Bradycardia, including sinus pause, heart block, severe bradycardia, and cardiac arrest have occurred with the use of beta blockers. Monitor heart rate and rhythm in patients receiving Labetalol Hydrochloride Tablets.

5.3Cardiac 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. Avoid Labetalol Hydrochloride Tablets in patients with overt congestive heart failure.

If patients develop signs or symptoms of heart failure during administration, discontinue Labetalol Hydrochloride Tablets and treat appropriately.

5.4Ischemic Heart Disease Abrupt cessation of therapy with beta blocking agents in patients with coronary artery disease can cause exacerbations of angina pectoris and, in some cases, myocardial infarction has been reported. Therefore, even in the absence of overt angina pectoris, after the discontinuation of Labetalol Hydrochloride Tablets observe patients for development or worsening of angina. If patient experiences angina or angina markedly worsens or if acute coronary insufficiency develops, promptly reinstitute Labetalol Hydrochloride Tablets and manage as unstable angina.

5.5Reactive Airway Disease and Nonallergic Bronchospasm Avoid use in patients with reactive airways disease. If Labetalol Hydrochloride Tablets are used, use the smallest effective dose, to minimize inhibition of endogenous or exogenous beta agonists.

5.6Hypoglycemia 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.

5.7Use in Patients with Pheochromocytoma Labetalol hydrochloride has been shown to be effective in lowering blood pressure and relieving symptoms in patients with pheochromocytoma;…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Hypotension [see Warnings and Precautions (5.1) Bradycardia [see Warnings and Precautions (5.2) ] Cardiac failure [see Warnings and Precautions (5.3) ] Ischemic heart disease [see Warnings and Precautions (5.4) ] Nonallergic bronchospasm [see Warnings and Precautions (5.5) )] Use in patients with pheochromocytoma [see Warnings and Precautions (5.7) ] Hepatic injury [see Warnings and Precautions (5.8) ] Risk of severe acute hypersensitivity reaction [see Warnings and Precautions (5.9) ] Most commonly observed adverse reactions: fatigue, nausea, dizziness ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Innogenix, LLC at 1-844-466-6469 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Adverse Reactions Resulting in Discontinuation of Treatment Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 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.

The incidence rates of adverse reactions listed in Table 1 were derived from multicenter, controlled clinical trials comparing labetalol hydrochloride and placebo over treatment periods of 3 and 4 months. Table 1: Adverse Reactions Occurring in at Least 2% of Patients and More Frequent on Labetalol Labetalol HCl (n=227) Placebo (n=98) Body as a whole Fatigue 5% 0% Headache 2% 1% Gastrointestinal Nausea 6% 1% Dyspepsia 3% 1% Central and Peripheral Nervous Systems Dizziness 11% 3% Autonomic Nervous System Nasal stuffiness 3% 0% Respiratory Dyspnea 2% 0% Special Senses Vertigo 2% 1% 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 Table 2 that depicts the entire US therapeutic trials data base for adverse reactions that are clearly or possibly dose related.

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Concomitant use with negative chronotropes can increase risk of bradycardia ( 7.1 ) Beta blockers antagonize the bronchodilator effect of beta-receptor agonists. ( 7.2 ) Increase hypotension may occur with halothane anesthesia. ( 7.3 ) Nitroglycerin may result in additional hypotensive effects. ( 7.4 )

7.1Negative Chronotopes Digitalis glycosides, diltiazem, verapamil, and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use with negative chronotropes can increase the risk of bradycardia or hypotension [see Warnings and Precautions (5.2) ]. Coadministration of labetalol HCl with non-dihydropyridine calcium-channel antagonists (e.g., verapamil) is contraindicated [see Contraindications (4) ].

7.2Bronchodilators Labetalol HCl antagonizes the bronchodilatory effect of beta-receptor agonist drugs; therefore, labetalol HCl is contraindicated in patients with bronchial asthma [see Contraindications (4) ].

7.3Anesthesia Synergism has been shown between halothane anesthesia and intravenously administered labetalol. During controlled hypotensive anesthesia using labetalol 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.

7.4Nitroglycerin Coadministration of labetalol HCl and nitroglycerine will have an additive effect in lowering blood pressure. Additionally, labetalol HCl blunts the reflex tachycardia produced by nitroglycerin. If labetalol HCl is used in patients with angina pectoris on nitroglycerin, monitor patients’ blood pressure and adjust labetalol dose as needed. In these patients, avoid initiating Labetalol Hydrochloride Tablets.

7.5Drug/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, a specific method, such as a high-performance liquid chromatographic assay with solid phase extraction should be employed in determining levels of catecholamines.

Labetalol 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. When patients being treated with labetalol have a positive urine test for amphetamine using these techniques, confirm using more specific methods, such as a gas chromatographic mass spectrometer technique.

7.4Nitroglycerin Coadministration of labetalol HCl and nitroglycerine will have an additive effect in lowering blood pressure. Additionally, labetalol HCl blunts the reflex tach…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary The extensive experience with use of labetalol in pregnant women, based on published interventional and observational studies, has not identified a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Untreated hypertension during pregnancy can lead to serious adverse outcomes for the mother and the fetus (see Clinical Considerations). In animal reproductive studies, oral administration of labetalol to pregnant rats and rabbits during organogenesis at doses up to approximately six and four times the maximum recommended human dose (MRHD), respectively, resulted in no fetal malformations; however, increased fetal resorptions were seen in both species at doses approximating the MRHD (see Data).

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Consideration Disease-Associated Maternal and/or Embryo/Fetal Risk Hypertension in pregnancy increase the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death.

Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal Adverse Reactions Labetalol crosses the placenta. Newonates born to mothers who are receiving labetalol during pregnancy, may be at risk for hypotension, bradycardia, hypoglycemia, and respiratory depression.

Neonates should be monitored for symptoms of hypotension, bradycardia, hypoglycemia and respiratly depression and mange accordingly. Data Human Data Data from published interventional and observational studies did not demonstrate an association between major congenital malformations and the use of labetalol in pregnancy, however, most studies reported the maternal use of intravenous labetalol occurring after 20 weeks gestation. The published literature has reported inconsistent findings of intrauterine growth retardation, preterm birth and perinatal mortality with maternal use of labetalol during pregnancy; however, these studies have methodological limitations hindering interpretation.

These studies cannot definitively establish the absence of risk during pregnancy. Animal Data 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. 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.

8.2Lactation Risk Summary Available published data report the presence of labetalol in human milk at low levels. There are no data on the effects on the breastfed infant and on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for labetalol and any potential adverse effects on the breastfed infant from labetalol or from the underlying maternal condition.

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.5Geriatric Use Pharmacokinetic studies indicate that the elimination of labetalol is reduced in elderly patients. Although elderly patients may initiate therapy at the currently recommended dosage of 100 mg twice daily, elderly patients will generally require lower maintenance dosages than nonelderly patients.

🤰 Pregnancy ~2 min read ▾

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 43 words ▾

🆘 Overdosage 130 words ▾

10 OVERDOSAGE 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. Treat symptoms of overdose with standard supportive care.

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. Treat symptoms of overdose with standard supportive care. Neither hemodialysis nor peritoneal dialysis removes a significant amount of labetalol hydrochloride from the general circulation (<1%).

The oral LD50 value of labetalol hydrochloride in the mouse is approximately 600 mg/kg and in the rat is >2 g/kg. The IV LD50in these species is 50 mg/kg to 60 mg/kg.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Labetalol hydrochloride combines both selective, competitive, alpha1‑adrenergic blocking and nonselective, competitive, beta‑adrenergic blocking activity. 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.

12.2Pharmacodynamics The capacity of labetalol hydrochloride to block alpha receptors in man has been demonstrated by attenuation of the pressor effect of phenylephrine and by a significant reduction of the pressor response caused by immersing the hand in ice cold water ("cold pressor test"). Labetalol hydrochloride's beta1 receptor blockade in man was demonstrated by a small decrease in the resting heart rate, attenuation of tachycardia produced by isoproterenol or exercise, and by attenuation of the reflex tachycardia to the hypotension produced by amyl nitrite.

Beta2 receptor blockade was demonstrated by inhibition of the isoproterenol induced fall in diastolic blood pressure. Both the alpha- and beta blocking actions of orally administered labetalol hydrochloride contribute to a decrease in blood pressure in hypertensive patients. Labetalol hydrochloride consistently, in dose related fashion, blunted increases in exercise induced blood pressure and heart rate, and in their double product.

The pulmonary circulation during exercise was not affected by labetalol hydrochloride dosing. The effects on A‑V nodal refractoriness were inconsistent. Single oral doses of labetalol hydrochloride administered to patients with coronary artery disease had no significant effect on sinus rate, intraventricular conduction, or QRS duration.

The atrioventricular (A‑V) conduction time was modestly prolonged in two of seven patients. In another study, IV labetalol hydrochloride slightly prolonged A‑V nodal conduction time and atrial effective refractory period with only small changes in heart rate. Labetalol hydrochloride produces dose‑related falls in blood pressure without reflex tachycardia and without significant reduction in heart rate, presumably through a mixture of its alpha- and beta‑blocking effects.

Hemodynamic effects are variable, with small, nonsignificant changes in cardiac output seen in some studies but not others, and small decreases in total peripheral resistance. Elevated plasma renins are reduced. Due to the alpha1‑receptor blocking activity of labetalol hydrochloride, blood pressure is lowered more in the standing than in the supine position, and symptoms of postural hypotension (2%), including rare instances of syncope, can occur.

Following oral administration, when postural hypotension has occurred, it has been transient and is uncommon when the recommended starting dose and titration increments are closely followed [see Dosage and Administration (2.1) ]. Symptomatic postural hypotension is most likely to occur 2 to 4 hours after a dose, especially following the use of large initial doses or upon large changes in dose. The peak effects of single oral doses of labetalol hydrochloride occur within 2 to 4 hours.

The duration of effect depends upon dose, lasting at least 8 hours following single oral doses of 100 mg and more than 12 hours following single oral doses of 300 mg. The maximum, steady‑state blood pressure response upon oral, twice‑a‑day dosing occurs within 24 to 72 hours. The antihypertensive effect of labetalol has a linear correlation with the logarithm of labetalol plasma concentration, and there is also a linear correlation between the reduction in exercise induced tachycardia occurring at 2 hours after oral administration of labetalol hydrochloride and the logarithm of the plasma concentration.

About 70% of the maximum beta‑blocking effect is present for 5 hours after the administration of a single oral dose of 400 mg with suggestion that about 40% remains at 8 hours.

12.3 Pharmacokinetics and Metabolism Absorption Labetalol hydrochloride is absorbed wi…

🧬 Mechanism of Action 40 words ▾

📦 How Supplied / Storage and Handling 162 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Labetalol Hydrochloride Tablets, USP 100 mg: Round, beige, film-coated tablets, plain on one side, scored and debossed with “I/126” on the other side. NDC 71247-126-01 bottles of 100 NDC 71247-126-05 bottles of 500 Labetalol Hydrochloride Tablets, USP 200 mg: Round, white, film-coated tablets, plain on one side, scored and debossed with “I/127” on the other side. NDC 71247-127-01 bottles of 100 NDC 71247-127-05 bottles of 500 Labetalol Hydrochloride Tablets, USP 300 mg: Round, blue, film-coated tablets, plain on one side and debossed with “I/130” on the other side: NDC 71247-130-01 bottles of 100 NDC 71247-130-05 bottles of 500 Storage Store Labetalol Hydrochloride Tablets at 20° to 25°C (68° 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 Innogenix, LLC. at 1-844-466-6469 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Distributed by: Innogenix, LLC.

Amityville, NY 11701 Rev. 09/2025

📋 Description 219 words ▾

11 DESCRIPTION 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, USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure: Labetalol hydrochloride, USP has the molecular formula C 19 H 24 N 2 O 3 •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 off-white crystalline powder, soluble in water.

Labetalol hydrochloride tablets, USP, for oral administration, contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each 100 mg tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), red iron oxide, titanium dioxide and yellow iron oxide. In addition, each 200 mg tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, pregelatinized starch (corn), titanium dioxide and triacetin.

In addition, each 300 mg tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, FD&C Blue #2, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), titanium dioxide. labetalol-structure

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

exacerbation: A flare-up or worsening of a condition.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

additive effect: When two medicines that do the same thing are taken together and their effects add up to a larger combined effect.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agonist: A substance that switches on a specific target in the body to produce an effect, the way a key turns a lock.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

angina pectoris: Chest pain or a squeezing feeling that happens when the heart muscle does not get enough blood and oxygen.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

cardiac arrest: A sudden stop of the heart's pumping that cuts off blood flow to the body, which is a medical emergency.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

crosses the placenta: When a substance passes from a pregnant mother's blood, through the placenta, and into the developing baby.

depression: A lasting low mood with loss of interest that affects everyday life.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

emesis: The medical word for vomiting, or bringing up the contents of the stomach through the mouth.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypoglycemia: Low blood sugar, when the amount of glucose (sugar) in the blood drops below the normal range.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

intrauterine growth restriction: When a baby grows more slowly than expected in the womb and is smaller than normal at birth.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

lactation: The making and release of milk from a mother's breasts after giving birth.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

monotherapy: Treatment using a single medicine by itself.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

preterm birth: Birth of a baby earlier than usual, before 37 weeks of pregnancy.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

refractory: Describing a disease that does not respond to, or improve with, treatment.

relative risk: A number comparing the chance of an event in one group with the chance of that same event in another group.

respiratory depression: Breathing that becomes too slow or too shallow to move enough air, so the body may not get enough oxygen.

syncope: The medical term for fainting, a brief loss of consciousness from a temporary drop in blood flow to the brain.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 71239-0845-00 · Natural 71247-0127-01 · Innogenix, →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

Labetalol Hydrochloride 100 mg Tablet, Film Coated, 100-count

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12 CLINICAL PHARMACOLOGY

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