FDA-filed SPL labeling · retrieved through openFDA

Fosinopril

Fosinopril is an ACE inhibitor used to treat high blood pressure and heart failure.

Brand name Monopril
Drug class ⓘ Angiotensin Converting Enzyme Inhibitor
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 11 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJan 20, 2023
Clinical labels in scope ⓘ11
AvailabilityRx
Earliest approval/marketing year ⓘ1991
FDA-listed product records ⓘ53
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 25, 2026
⭐ Fosinopril at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Fosinopril is a well-established ACE inhibitor that lowers high blood pressure and helps manage heart failure by relaxing blood vessels and easing the heart's workload. It must never be used during pregnancy, and you should watch for rare but serious signs like sudden swelling of the face or throat, which require emergency care. Take it as prescribed, keep all follow-up appointments, and let your doctor know about all other medicines you are using.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Fosinopril can seriously harm or kill an unborn baby. If you discover you are pregnant while taking this medication, stop it as soon as possible and contact your doctor right away. Drugs that work on the renin-angiotensin system — the system fosinopril targets — have been shown to cause fetal injury and death, especially when used during the second and third trimesters of pregnancy. The risks include poor fetal kidney function, too little amniotic fluid, abnormal bone development, and in severe cases, death of the baby. This is not a theoretical risk — it is a serious, documented danger.

Read the full warning on DailyMed →

📖 Fosinopril: Patient Information Guide

A plain-language walkthrough of Fosinopril — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Fosinopril is an oral ACE inhibitor approved for the following conditions:

  • High blood pressure (hypertension) — Fosinopril Sodium tablets can be used alone or combined with a thiazide diuretic when additional blood pressure lowering is needed
  • Heart failure — Fosinopril Sodium tablets are used as add-on therapy alongside diuretics, with or without digitalis, to help manage symptoms and improve exercise tolerance
⚙️How it works▾

Fosinopril is a prodrug — after you swallow it, your body converts it into the active form, fosinoprilat. Fosinoprilat blocks ACE (angiotensin-converting enzyme), which normally helps produce angiotensin II, a chemical that tightens blood vessels and raises blood pressure. By blocking this process, fosinopril allows blood vessels to relax, lowers blood pressure, and also reduces the amount of aldosterone (a hormone that causes the body to retain salt and water). In heart failure, this dual effect reduces both the pressure the heart pumps against (afterload) and the volume it must handle (preload), easing its overall workload.

Because fosinopril is cleared through both the liver and kidneys, it can generally be used at standard doses even in patients with significant kidney disease — an advantage compared with some other ACE inhibitors. However, ACE inhibitors as a class tend to have a smaller blood-pressure-lowering effect in Black patients compared to non-Black patients.

💊How it's taken▾

Fosinopril Sodium tablets are taken by mouth, typically once a day. Food may slow absorption slightly but does not reduce the total amount absorbed, so it can be taken with or without food. For heart failure, patients are usually observed closely after the first dose for signs of low blood pressure.

  • If you are on a diuretic (water pill), your doctor may adjust or pause it before starting fosinopril to reduce the chance of a blood pressure drop
  • Do not use potassium supplements or potassium-containing salt substitutes unless your doctor directs you to — they can raise potassium to unsafe levels
  • Never stop taking fosinopril on your own; always check with your prescriber first
🤒Side effects — in detail▾

Most side effects with fosinopril are mild and temporary, but there are a few important ones to know about:

  • Dry, nagging cough — a well-known ACE inhibitor side effect; talk to your doctor if it becomes bothersome
  • Dizziness or lightheadedness — especially when standing up quickly (orthostatic hypotension)
  • Nausea or vomiting
  • Diarrhea
  • Fatigue or weakness
  • Headache
  • Elevated potassium levels (hyperkalemia) — may cause muscle weakness or heart rhythm changes

Seek emergency care immediately for sudden swelling of the face, lips, tongue, or throat (angioedema) — this is rare but can be life-threatening. Also contact your doctor right away if you develop yellowing of the skin or eyes, significant drop in urination, or signs of low blood pressure such as fainting.

⚠️Warnings & precautions▾
  • Fetal toxicity (most critical): Fosinopril can cause fetal injury or death, especially in the second and third trimesters. Stop the medication as soon as pregnancy is detected and contact your doctor immediately.
  • Angioedema (severe swelling): Rare but potentially fatal swelling of the face, tongue, throat, or intestines can occur. Throat swelling is a medical emergency. Black patients and those taking mTOR inhibitors (e.g., temsirolimus) are at higher risk.
  • Low blood pressure (hypotension): Most likely in patients who are dehydrated, on high-dose diuretics, have low sodium, or have heart failure. The first dose requires close monitoring in heart failure patients.
  • Kidney function changes: Fosinopril can worsen kidney function, particularly in people with heart failure or severe kidney disease. Blood and urine tests may be needed regularly.
  • High potassium (hyperkalemia): Risk increases when combined with potassium supplements, potassium-sparing diuretics, or salt substitutes containing potassium.
  • Liver failure: Rarely reported with ACE inhibitors. Stop fosinopril and seek care if jaundice or markedly abnormal liver tests develop.
  • Blood count changes: Rare risk of low white blood cell counts (agranulocytosis), particularly in patients with kidney disease or connective-tissue diseases such as lupus.
🔀What it interacts with▾

Fosinopril can interact with several medications and substances — tell your doctor and pharmacist about everything you take:

  • Potassium supplements, potassium-sparing diuretics, or potassium-containing salt substitutes — can raise potassium to dangerous levels when combined with fosinopril
  • Diuretics (water pills) — increase the risk of a blood pressure drop, especially with the first dose of fosinopril
  • Lithium — fosinopril can raise lithium blood levels, increasing the risk of lithium toxicity; frequent monitoring is needed
  • Antacids (aluminum/magnesium-based) — may reduce fosinopril absorption; separate doses by at least 2 hours
  • NSAIDs (ibuprofen, naproxen) and COX-2 inhibitors — can blunt fosinopril's blood-pressure effect and may impair kidney function, especially in older or dehydrated patients
  • Injectable gold (sodium aurothiomalate) — rarely causes flushing, nausea, and low blood pressure when combined with ACE inhibitors
  • mTOR inhibitors (e.g., temsirolimus) — increase the risk of angioedema (dangerous swelling)
  • Aliskiren — must not be combined with fosinopril in patients with diabetes; avoid in those with kidney disease due to risk of low blood pressure, high potassium, and kidney failure
  • Other ACE inhibitors or angiotensin receptor blockers (ARBs) — combining two drugs that block the same system raises risk of low blood pressure, high potassium, and kidney damage

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Pregnancy: Do not take fosinopril if you are pregnant. Stop immediately and contact your doctor if you become pregnant while taking it — the drug can seriously harm the baby.
  • Prior angioedema with any ACE inhibitor: You must not take fosinopril if you have had dangerous swelling reactions with any ACE inhibitor.
  • Hypersensitivity: Do not take fosinopril if you are allergic to it or any other ACE inhibitor.
  • Diabetes + aliskiren use: Do not combine fosinopril with aliskiren if you have diabetes.
  • Kidney disease: Fosinopril can be used in kidney impairment at standard doses due to its dual liver/kidney elimination route, but kidney function and potassium should be monitored.
  • Liver disease: Fosinopril clearance is reduced in patients with liver cirrhosis; your doctor may adjust monitoring or dosing.
  • Collagen-vascular diseases (e.g., lupus, scleroderma): Higher risk of blood count problems; white blood cell monitoring may be needed.
  • Black patients: ACE inhibitors tend to lower blood pressure less effectively and carry a higher rate of angioedema in this population — discuss all options with your prescriber.
  • Children under 50 kg: An appropriate tablet strength is not available for children weighing less than 50 kg.
  • Older adults: Side effect rates in patients 65 and older were similar to younger patients in clinical trials, but close monitoring is still appropriate.
  • Dialysis patients: Fosinopril is not well removed by dialysis; anaphylactoid (severe allergic-like) reactions have been reported with certain high-flux dialysis membranes.
🚑If you take too much▾

The most likely effect of taking too much fosinopril is a significant drop in blood pressure (hypotension), which can cause dizziness, fainting, or weakness. Fosinopril is not well removed by dialysis, so standard supportive care — such as intravenous fluids to restore blood pressure — is the primary approach. If you suspect an overdose, seek emergency medical help immediately.

📡Pharmacodynamics — effects in the body▾

Fosinopril begins to significantly suppress ACE activity within 2 hours of a dose. A single dose of fosinopril suppresses the ACE enzyme by 90% or more for up to 12 hours, and meaningful suppression (over 85%) is still measurable at 24 hours — helping explain why once-daily dosing is effective for most patients. In the blood, fosinopril also causes small increases in potassium levels over time, which is worth monitoring, especially in patients on other medications that raise potassium.

🔬Pharmacokinetics — how your body processes it▾

After swallowing a fosinopril tablet, the drug is absorbed through the upper small intestine — food may slow this slightly but does not reduce how much is absorbed overall. The body converts fosinopril into its active form (fosinoprilat) within hours, with peak blood levels reached in about 3 hours. Fosinoprilat is cleared about equally by the liver and kidneys — a dual elimination pathway that is unusual among ACE inhibitors and means that even patients with severe kidney disease typically do not require dose adjustments. The effective half-life (how long the drug stays active) is roughly 11 to 14 hours in most patients.

📦How to store it▾

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Protect from moisture by keeping bottle tightly closed.

📄 Written from Fosinopril’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

166

Supplements & herbs that interact with Fosinopril

166 supplements and herbal products have documented interactions with Fosinopril in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 6
  • Moderate · 136
  • Minor · 24
Every supplement checked against Fosinopril — ranked by severity The full interaction hub: 6 major · 136 moderate · 24 minor · every one linked to its full report. Check Fosinopril against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Fosinopril has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

See the full Fosinopril nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Fosinopril — the kind of thing our pharmacy team would talk through with you at the counter.

What is fosinopril actually used for? ▾
Fosinopril is used to treat two main conditions: high blood pressure and heart failure. For high blood pressure, it can be used on its own or paired with a water pill (diuretic) if your blood pressure needs extra control. For heart failure, it's added on top of other medications you're already taking — it helps ease the workload on your heart by relaxing your blood vessels.
I keep hearing that ACE inhibitors cause a cough. Is that true with fosinopril? ▾
Yes, a dry, persistent cough is a well-known side effect of this whole class of medications, including fosinopril. It affects some patients and not others — there's no way to predict it in advance. If the cough becomes really bothersome, let your doctor know. They may consider switching you to a different type of blood pressure medication that doesn't cause this side effect.
What should I watch out for and call someone about right away? ▾
The most urgent thing is sudden swelling of your face, lips, tongue, or throat — that's called angioedema, and it can block your airway. If that happens, call 911 immediately; don't wait. You should also call your doctor promptly if you feel very dizzy or faint, notice yellowing of your skin or eyes, see a big drop in how much you're urinating, or feel significant muscle weakness or an irregular heartbeat.
Can I take fosinopril if I'm pregnant or trying to get pregnant? ▾
No — fosinopril is not safe during pregnancy. It can cause very serious harm to a developing baby, including kidney damage, abnormal bone development, and in some cases death, especially in the second and third trimesters. If there's any chance you could become pregnant, talk to your doctor before starting this medication. And if you discover you're pregnant while taking it, stop it and contact your doctor right away.
Are there foods or other medicines I need to be careful with? ▾
A few important ones: don't use potassium supplements or salt substitutes that contain potassium without checking with your doctor first — they can push your potassium to dangerous levels when combined with fosinopril. If you're taking lithium, your doctor will need to monitor your lithium levels closely. Common pain relievers like ibuprofen or naproxen (NSAIDs) can reduce how well fosinopril works and may affect your kidneys, so use them cautiously. And if you take antacids, try to space them at least 2 hours apart from your fosinopril dose.
I have kidney disease — is it safe for me to take fosinopril? ▾
Fosinopril has an advantage here compared to many other ACE inhibitors: it's cleared by both your liver and your kidneys, so even if your kidneys aren't working well, your body can still eliminate the drug reasonably well. Your doctor will likely monitor your kidney function and potassium levels while you're on it, but kidney disease alone doesn't automatically rule out this medication. Make sure your doctor knows the full picture of your kidney health before you start.
Is Fosinopril available over the counter? ▾
Fosinopril is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Fosinopril first available? ▾
Fosinopril has been available in the United States since at least 1991, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Fosinopril? ▾
Fosinopril is supplied by 13 manufacturers listed in the FDA NDC Directory, including Aurobindo Pharma Limited, Bryant Ranch Prepack, Chartwell RX, LLC.

💬 Answers drafted from Fosinopril’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Fosinopril comes

Fosinopril is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
How this form is used
What it may be used for
  • Fosinopril Sodium tablets are used to treat high blood pressure (hypertension), alone or with a diuretic
  • Fosinopril Sodium tablets are used to help manage heart failure, added to standard therapy including diuretics with or without digitalis
Important instructions
  • Fosinopril Sodium tablets are taken by mouth once daily, with or without food
  • Fosinopril Sodium tablets should be taken at about the same time each day; follow your prescriber's guidance on timing and dose adjustments
  • If you are also taking an antacid, separate it from Fosinopril Sodium by at least 2 hours to avoid reducing absorption
  • Do not stop taking Fosinopril Sodium tablets without talking to your doctor first
Available strengths 3 strengths
50 FDA-listed product records ⓘ

📊 Fosinopril across the U.S. market

How Fosinopril appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
13
Manufacturers
1
Brand names
53
FDA-listed product records ⓘ
1991
First marketed ⓘ

Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Aurobindo Pharma Limited19%
Bryant Ranch Prepack13%
Chartwell RX, LLC11%
Cipla USA Inc.11%
Exelan Pharmaceuticals, Inc.11%
A-S Medication Solutions8%
Other makers26%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Fosinopril is used

A general measure of how commonly Fosinopril is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Fosinopril is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

4,328
Medicaid prescriptions filled (Q1–Q4 2025)
$82,090 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Fosinopril prescribed? Of the 1,597 medications we measure, Fosinopril ranks #1,067 by Medicaid prescriptions — more than 33% of them.

Where Fosinopril ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Fosinopril product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 40 mg oral tablet is the most-dispensed Fosinopril product — about 43% of these Medicaid prescriptions.

fosinopril sodium 40 MG Oral Tablet Most dispensed

1,862 Medicaid prescriptions (Q1–Q4 2025) 43% of Fosinopril prescriptions shown $41,003 gross reimbursement (before rebates) ≈ $22 per prescription (gross)

Summed across the 2 of 30 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 857187

fosinopril sodium 20 MG Oral Tablet

1,506 Medicaid prescriptions (Q1–Q4 2025) 35% of Fosinopril prescriptions shown $25,614 gross reimbursement (before rebates) ≈ $17 per prescription (gross)

Summed across the 2 of 28 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 857183

fosinopril sodium 10 MG Oral Tablet

960 Medicaid prescriptions (Q1–Q4 2025) 22% of Fosinopril prescriptions shown $15,473 gross reimbursement (before rebates) ≈ $16 per prescription (gross)

Summed across the 2 of 32 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 857169

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Fosinopril, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 6 of 90 listed Fosinopril NDCs with Medicaid activity.

🔍 Compare Fosinopril products

A representative set of FDA-listed product records for Fosinopril — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 53 of 53 products — FDA National Drug Code Directory. See every product, package size and price: browse all 53 Fosinopril NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Fosinopril RxCUI 50166 1 dose form · 3 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 372274 In current FDA listings
    Clinical drug / strength (SCD) sodium 10 MG RxCUI 857169 sodium 20 MG RxCUI 857183 sodium 40 MG RxCUI 857187

Look up RxCUI 50166 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Monopril

🏭 Manufacturers & labelers

Aurobindo Pharma Limited 10 Bryant Ranch Prepack 7 Chartwell RX, LLC 6 Cipla USA Inc. 6 Exelan Pharmaceuticals, Inc. 6 A-S Medication Solutions 4 Solco Healthcare LLC 4 Rising Pharma Holdings, Inc. 3 AvPAK 2 Preferred Pharmaceuticals, Inc. 2 Denton Pharma, Inc. dba Northwind Pharmaceuticals 1 Hetero Drugs Limited 1 Zhejiang Huahai Pharmaceutical Co., Ltd. 1

RxNorm drug class

Fosinopril belongs to the Angiotensin Converting Enzyme Inhibitor class.

Pharmacologic class Angiotensin Converting Enzyme Inhibitor
Drug family (ATC) ACE inhibitors, plain
How it works Angiotensin-converting Enzyme Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jan 20, 2023
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Fosinopril.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Fosinopril after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
11
NDC products indexed
53
Distinct labelers/manufacturers represented
13
Linked representative label ⓘ
Cipla USA Inc.
Linked label effective
Jan 20, 2023
Composite sections available
19
Linked SPL Set ID
736fe52f-69fb-48b2-b1c5-f06531878538
Linked SPL Document ID
6d672087-9b6a-4afe-8c3e-0616943a82cf
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 11 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Cipla USA Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.