FDA-filed SPL labeling · retrieved through openFDA

Empagliflozin / Metformin

Empagliflozin/metformin is a two-in-one tablet used alongside diet and exercise to control blood sugar in type 2 diabetes — and the empagliflozin component also helps protect the heart and kidneys.

Brand names SynjardySynjardy XR
Drug class ⓘ Sodium-glucose Cotransporter 2 Inhibitor
Rx Forms 2 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 2 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 effectiveAug 11, 2026
Clinical labels in scope ⓘ2
AvailabilityRx
Earliest approval/marketing year ⓘ2015
FDA-listed product records ⓘ40
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 22, 2026
⭐ Empagliflozin / Metformin at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Empagliflozin/metformin is a well-established two-in-one tablet that controls blood sugar and, through the empagliflozin component, offers real heart and kidney protection in the right patients. The most important thing to know is the rare but serious lactic acidosis risk from metformin — learn the warning signs and don't ignore unusual fatigue or muscle aches. Taken as directed with food, and with regular kidney check-ups, most people tolerate it well.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

This medication carries a serious boxed warning about a rare but potentially fatal condition called lactic acidosis — a dangerous buildup of lactic acid in the blood caused by the metformin component. It has been linked to deaths in postmarketing reports. The tricky part: early symptoms are vague and easy to dismiss, including unusual fatigue, muscle aches, trouble breathing, stomach pain, or feeling drowsy or cold. You're at higher risk if you have kidney or liver problems, are 65 or older, drink alcohol heavily, are having surgery or an imaging procedure with contrast dye, or are very ill. If you experience any of these symptoms, stop the medication and go to the emergency room right away — this is a medical emergency that may require treatment in a hospital, including dialysis to remove the drug.

Read the full warning on DailyMed →

📖 Empagliflozin / Metformin: Patient Information Guide

A plain-language walkthrough of Empagliflozin / Metformin — 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▾

Empagliflozin/metformin is used alongside diet and exercise to manage blood sugar in type 2 diabetes. It also provides broader benefits through its empagliflozin component:

  • Type 2 diabetes — improves blood sugar control in adults; the immediate-release form also approved for children 10 and older
  • Cardiovascular (heart) protection — reduces the risk of dying from heart-related causes in adults with established heart disease
  • Heart failure — lowers the risk of cardiovascular death and hospitalization for heart failure
  • Chronic kidney disease — slows progression and reduces the risk of kidney failure, cardiovascular death, and hospitalization in adults at risk
⚙️How it works▾

Empagliflozin blocks a kidney protein called SGLT2 that normally recycles sugar back into the blood. By blocking it, excess glucose spills out in the urine, lowering blood sugar without requiring extra insulin. It also reduces sodium reabsorption in the kidneys, which lowers pressure inside the kidney's filtering units and reduces the heart's workload — explaining its heart and kidney benefits beyond blood sugar.

Metformin takes a different approach: it tells the liver to produce less glucose on its own, slows sugar absorption from the gut, and makes the body's cells respond better to insulin. Importantly, metformin does not cause the pancreas to pump out extra insulin, so it doesn't trigger low blood sugar on its own.

💊How it's taken▾

This medication comes in two forms with different dosing schedules:

  • Immediate-release tablets (Synjardy): taken twice daily, with meals
  • Extended-release tablets (Synjardy XR): taken once daily, with your morning meal — swallow whole, do not split, crush, chew, or dissolve

Your prescriber will start you at a lower dose and increase it gradually to minimize stomach side effects. Kidney function is checked before starting and monitored throughout. Always follow your prescriber's specific instructions — do not adjust your dose on your own.

🤒Side effects — in detail▾

Most people tolerate this medication well. The most common side effects include:

  • Urinary tract infections
  • Vaginal yeast infections (in women)
  • Diarrhea, nausea, or vomiting (especially when starting metformin)
  • Gas and stomach discomfort
  • Indigestion
  • Fatigue or weakness
  • Headache

Serious reactions requiring prompt medical attention include lactic acidosis (muscle aches, trouble breathing, stomach pain, extreme fatigue), ketoacidosis, severe genital infections, urinary infections spreading to the kidney, significant dehydration, and severe allergic reactions such as swelling of the face or throat.

⚠️Warnings & precautions▾
  • Lactic acidosis (metformin): A rare but life-threatening buildup of lactic acid — most likely in people with kidney or liver problems, those over 65, heavy drinkers, or anyone severely ill. Symptoms can be subtle: fatigue, muscle pain, stomach discomfort, difficulty breathing. Stop the medication and seek emergency care immediately if suspected.
  • Ketoacidosis: A dangerous acid buildup that can occur even with near-normal blood sugar — watch for nausea, vomiting, stomach pain, or difficulty breathing.
  • Fournier's gangrene: A rare but severe bacterial infection in the genital/groin area. Go to the ER immediately if you notice pain, swelling, redness, or warmth there along with a fever.
  • Urinary and genital infections: More common because extra sugar passes through the urine — report symptoms promptly.
  • Volume depletion (dehydration): Especially in older adults or those on diuretics — dizziness or lightheadedness when standing up is a warning sign.
  • Low blood sugar: Higher risk if you also take insulin or a sulfonylurea; children 10 and older are also at higher risk regardless of insulin use.
  • Vitamin B12 deficiency: Metformin can lower B12 over time — annual blood checks are recommended.
  • Lower limb amputation risk: Monitor feet and legs for infections or sores, and treat any problems promptly.
🔀What it interacts with▾

Several medications and substances can interact with empagliflozin/metformin and either raise the risk of serious side effects or affect blood sugar control:

  • Topiramate and similar drugs (carbonic anhydrase inhibitors): Raise the risk of lactic acidosis — more frequent monitoring needed
  • Ranolazine, cimetidine, dolutegravir, vandetanib: Slow metformin's removal from the body, raising lactic acidosis risk
  • Alcohol: Interferes with how metformin handles lactic acid — avoid heavy drinking
  • Diuretics (water pills): Combined with empagliflozin, can increase dehydration risk
  • Insulin or sulfonylureas: Increase the chance of low blood sugar — dose adjustments may be needed
  • Blood-sugar-raising drugs (steroids, thiazides, estrogens, thyroid hormones, and others): May blunt this medication's blood sugar control
  • Iodinated contrast dye (imaging procedures): May require temporarily stopping this medication to avoid kidney stress and lactic acidosis risk

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▾
  • Severely reduced kidney function (eGFR below 30): Contraindicated — do not use
  • Starting in patients with eGFR below 45: Not recommended due to the metformin component
  • Metabolic acidosis or diabetic ketoacidosis: Contraindicated — do not use
  • Allergy to empagliflozin, metformin, or any tablet ingredient: Do not use
  • Liver problems: Avoid — raises risk of lactic acidosis
  • Type 1 diabetes: Not recommended — may raise risk of ketoacidosis
  • Polycystic kidney disease or recent IV immunosuppressive therapy: Empagliflozin component not recommended for kidney disease in these groups
  • Pregnancy (especially 2nd and 3rd trimester): Not recommended — potential harm to fetal kidneys
  • Breastfeeding: Not recommended
  • Adults 65 and older: Higher risk of dehydration and kidney-related side effects — closer monitoring needed
  • Children under 10: The extended-release form is not approved for children; the immediate-release form is approved only for ages 10 and up
🚑If you take too much▾

Taking too much metformin raises the risk of lactic acidosis — a dangerous acid buildup in the blood that has occurred in about one-third of reported metformin overdose cases. If you suspect an overdose, call Poison Control at 1-800-222-1222 right away or go to the nearest emergency room. In severe cases, hemodialysis (a blood-filtering procedure) can help remove metformin from the body.

📡Pharmacodynamics — effects in the body▾

Empagliflozin begins increasing the amount of glucose excreted in the urine almost immediately after the first dose, and this effect is sustained with ongoing daily use. It also modestly increases urine volume, particularly in the first day or two of treatment. At normal and higher-than-normal doses, empagliflozin has not been shown to affect the heart's electrical rhythm (QT interval), which is reassuring from a cardiac safety standpoint.

🔬Pharmacokinetics — how your body processes it▾

Empagliflozin is absorbed quickly, reaching peak blood levels about 1.5 hours after a dose. Food does not meaningfully change how much empagliflozin gets into the body, so it can be taken with or without food. For the extended-release metformin component, a high-fat meal significantly increases the amount of metformin absorbed and delays the time it takes to peak — which is why taking Synjardy XR with food is important for consistent results. Both components are cleared by the kidneys, which is why kidney function is checked before starting and monitored throughout treatment.

📦How to store it▾

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .

📄 Written from Empagliflozin / Metformin’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 →

🩺 Pharmacist Counseling Corner

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

Why is my doctor prescribing one pill that has two different medicines in it? ▾
Great question — combining empagliflozin and metformin into one tablet is mostly about convenience. Both medicines help control your blood sugar, but they work in completely different ways, so together they do a better job than either one alone. And instead of taking two separate pills, you only have to manage one. For people who also have heart disease, heart failure, or kidney disease, the empagliflozin part provides extra protection beyond just blood sugar.
I've heard metformin can cause a dangerous condition with lactic acid — should I be worried? ▾
It's worth knowing about, but it's also quite rare. The risk is real mainly for people with kidney problems, liver disease, heavy alcohol use, or who are seriously ill. Your doctor will check your kidney function before and during treatment precisely to catch any red flags early. The key is knowing the warning signs: unusual muscle aches, trouble breathing, stomach pain, feeling very tired or cold, or dizziness. If those happen, stop the medication and get to an emergency room — don't wait. For most healthy adults taking it as prescribed, the risk is very low.
Will this medication make my blood sugar go too low? ▾
On its own, this combination doesn't usually cause low blood sugar — metformin in particular doesn't trigger extra insulin. The risk goes up, though, if you're also taking insulin or a pill called a sulfonylurea (like glipizide or glimepiride). If that's your situation, your doctor may lower your dose of those other medicines. Also, if you're a child or teenager taking this, there's a higher chance of low blood sugar, so keep a closer eye on your readings and know the symptoms: shakiness, sweating, confusion, or a racing heartbeat.
I keep getting yeast infections since starting this — is that from the medication? ▾
Yes, unfortunately that's one of the known side effects of empagliflozin. Because the medication works by pushing extra sugar out through your urine, it can create a more favorable environment for yeast and bacteria in the genital area. Staying well hydrated and keeping the area clean can help. If infections become frequent or severe, talk to your doctor — there are ways to manage this. Also, be alert to any pain, swelling, or redness in the groin area with a fever, as that would need emergency evaluation right away.
Do I need to stop this medication before a surgery or a CT scan with dye? ▾
Yes, and this is important. The metformin in this tablet can interact with the contrast dye used in certain imaging scans (like CT scans with contrast), and in some situations it needs to be paused. Similarly, your doctor will likely ask you to hold the medication at least three days before any surgery or procedure that involves prolonged fasting. Always tell your surgeon, radiologist, or any specialist that you take this medication so they can advise you on timing. Don't just stop it on your own without guidance.
Is it safe to take this if I'm pregnant or trying to get pregnant? ▾
This medication is not recommended during the second and third trimesters of pregnancy because animal studies showed the empagliflozin component can affect kidney development in the fetus. If you're planning to become pregnant, or find out you are pregnant, let your doctor know right away so they can review your treatment. It's also not recommended while breastfeeding. Controlling your blood sugar well during pregnancy is very important for both you and your baby, so your doctor will work with you to find the safest alternative.
Is Empagliflozin / Metformin available over the counter? ▾
Empagliflozin / Metformin 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 Empagliflozin / Metformin first available? ▾
Empagliflozin / Metformin has been available in the United States since at least 2015, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Empagliflozin / Metformin? ▾
Empagliflozin / Metformin is supplied by 2 manufacturers listed in the FDA NDC Directory, including Boehringer Ingelheim Pharmaceuticals, Inc., Patheon Puerto Rico, Inc..

💬 Answers drafted from Empagliflozin / Metformin’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

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💊 How Empagliflozin / Metformin comes

Empagliflozin / Metformin is available in 2 forms. 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.

📊 Empagliflozin / Metformin across the U.S. market

How Empagliflozin / Metformin 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.

2
Dose forms ⓘ
2
Manufacturers
2
Brand names
40
FDA-listed product records ⓘ
2015
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Boehringer Ingelheim Pharmaceuticals, Inc.80%
Patheon Puerto Rico, Inc.20%

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

📈 How widely Empagliflozin / Metformin is used

A general measure of how commonly Empagliflozin / Metformin 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 Empagliflozin / Metformin 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.

139,145
Medicaid prescriptions filled (Q1–Q4 2025)
$110.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Empagliflozin / Metformin prescribed? Of the 1,596 medications we measure, Empagliflozin / Metformin ranks #453 by Medicaid prescriptions — more than 72% of them.

Where Empagliflozin / Metformin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #453 of 1,596
#448 Dexlansoprazole 141,938 Rx #449 Levocarnitine 141,917 Rx #450 Acetazolamide 141,794 Rx #451 Letrozole 140,810 Rx #452 Cenobamate 139,992 Rx #453 Empagliflozin / Metfor... 139,145 Rx #454 Ramelteon 138,690 Rx #455 Umeclidinium Oral Inha... 137,953 Rx #456 Dexamethasone / Tobram... 137,322 Rx #457 Etanercept Injection 136,826 Rx #458 Magnesium Sulfate, Pot... 136,236 Rx

Utilization by Empagliflozin / Metformin 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 12.5 mg / 1000 mg oral tablet is the most-dispensed Empagliflozin / Metformin product — about 33% of these Medicaid prescriptions.

empagliflozin 12.5 MG / metformin hydrochloride 1000 MG Oral Tablet Most dispensed

45,744 Medicaid prescriptions (Q1–Q4 2025) 33% of Empagliflozin / Metformin prescriptions shown $38.5M gross reimbursement (before rebates) ≈ $843 per prescription (gross)

Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1665367

24 HR empagliflozin 12.5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet

36,247 Medicaid prescriptions (Q1–Q4 2025) 26% of Empagliflozin / Metformin prescriptions shown $24.4M gross reimbursement (before rebates) ≈ $675 per prescription (gross)

Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1862691

24 HR empagliflozin 25 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet

17,581 Medicaid prescriptions (Q1–Q4 2025) 13% of Empagliflozin / Metformin prescriptions shown $15.8M gross reimbursement (before rebates) ≈ $901 per prescription (gross)

Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1862695

empagliflozin 5 MG / metformin hydrochloride 1000 MG Oral Tablet

12,389 Medicaid prescriptions (Q1–Q4 2025) 9% of Empagliflozin / Metformin prescriptions shown $10.1M gross reimbursement (before rebates) ≈ $814 per prescription (gross)

Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1664326

24 HR empagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet

7,432 Medicaid prescriptions (Q1–Q4 2025) 5% of Empagliflozin / Metformin prescriptions shown $6.9M gross reimbursement (before rebates) ≈ $928 per prescription (gross)

Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1862685

empagliflozin 12.5 MG / metformin hydrochloride 500 MG Oral Tablet

7,074 Medicaid prescriptions (Q1–Q4 2025) 5% of Empagliflozin / Metformin prescriptions shown $5.4M gross reimbursement (before rebates) ≈ $761 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1664323

24 HR empagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet

6,876 Medicaid prescriptions (Q1–Q4 2025) 5% of Empagliflozin / Metformin prescriptions shown $4.5M gross reimbursement (before rebates) ≈ $655 per prescription (gross)

Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1862700

empagliflozin 5 MG / metformin hydrochloride 500 MG Oral Tablet

5,802 Medicaid prescriptions (Q1–Q4 2025) 4% of Empagliflozin / Metformin prescriptions shown $4.6M gross reimbursement (before rebates) ≈ $791 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1664315

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 Empagliflozin / Metformin, 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 16 of 26 listed Empagliflozin / Metformin NDCs with Medicaid activity.

🔍 Compare Empagliflozin / Metformin products

A representative set of FDA-listed product records for Empagliflozin / Metformin — 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 40 of 40 products — FDA National Drug Code Directory. See every product, package size and price: browse all 40 Empagliflozin / Metformin NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.

Multiple ingredients (MIN) Empagliflozin / Metformin RxCUI 1664314 2 dose forms · 8 strengths

Look up RxCUI 1664314 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

Synjardy Synjardy XR

🏭 Manufacturers & labelers

Boehringer Ingelheim Pharmaceuticals, Inc. 32 Patheon Puerto Rico, Inc. 8

RxNorm drug class

Empagliflozin / Metformin belongs to the Sodium-Glucose Cotransporter 2 Inhibitor class.

Pharmacologic class Sodium-Glucose Cotransporter 2 Inhibitor
Drug family (ATC) Sodium-glucose co-transporter 2 (SGLT2) inhibitors
How it works Sodium-Glucose Transporter 2 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 Aug 11, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Empagliflozin / Metformin.
📈
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 Empagliflozin / Metformin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
NDC products indexed
40
Distinct labelers/manufacturers represented
2
Linked representative label ⓘ
Boehringer Ingelheim Pharmaceuticals, Inc.
Linked label effective
Aug 11, 2026
Composite sections available
24
Linked SPL Set ID
8006ba29-ee3a-f852-a9bb-c8ec9b41cf66
Linked SPL Document ID
92a5c89e-3862-4a40-aee0-9134938f9629
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 2 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. Boehringer Ingelheim Pharmaceuticals, 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.