FDA-filed SPL labeling · retrieved through openFDA

Varenicline

Varenicline is a prescription medication available as tablets (for smoking cessation) and as a nasal spray (Tyrvaya, for dry eye disease).

Brand names ChantixTyrvayaApo-varenicline
Drug classes ⓘ Cholinergic Receptor Agonist
Rx Forms 2 Routes Oral · Nasal
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 40 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 effectiveApr 15, 2023
Clinical labels in scope ⓘ40
AvailabilityRx
Earliest approval/marketing year ⓘ2006
FDA-listed product records ⓘ159
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 22, 2026 🚨Recall on record · 3
Other forms & routes:
Nasal
⭐ Varenicline at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Varenicline tablets (Chantix and generics) are a proven prescription aid for quitting smoking, and Tyrvaya nasal spray is a separate varenicline product approved specifically for dry eye disease — these two products have different uses and should not be confused. Nausea is the most common side effect of the tablets and often improves over time, but watch closely for any changes in mood, behavior, or thoughts of self-harm and contact your doctor immediately if they occur. Always use varenicline exactly as prescribed and tell your doctor about all medicines you take, especially if you have kidney disease, heart disease, or a mental health history.
How we write & review this content — our editorial policy →

📖 Varenicline: Patient Information Guide

A plain-language walkthrough of Varenicline — 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▾

Varenicline is available in two distinct products with different approved uses:

  • Varenicline tablets (brands: Chantix, Apo-varenicline, Varenicline, Varenicline Tartrate) — approved as an aid to smoking cessation in adults
  • Tyrvaya nasal spray (varenicline solution) — approved to treat the signs and symptoms of dry eye disease
⚙️How it works▾

For smoking cessation, varenicline tablets bind selectively to α4β2 nicotinic acetylcholine receptors — specific docking sites in the brain that nicotine normally activates. By partially stimulating these receptors, varenicline eases withdrawal symptoms and cravings. At the same time, it physically blocks nicotine from attaching to those receptors, so smoking a cigarette produces much less of the pleasurable dopamine surge that reinforces the habit.

Tyrvaya (varenicline nasal spray) works as a cholinergic agonist — meaning it activates nerve pathways that signal the eye and surrounding glands to produce more of the natural tear film, relieving dry eye symptoms. This is a completely different mechanism from the tablets' action in the brain.

💊How it's taken▾

Varenicline tablets are taken by mouth, typically starting once daily and stepping up to twice daily over the first week, then continuing twice daily for a full course of treatment — the total duration is guided by your prescriber. Tablets can be taken with or without food. Tyrvaya nasal spray is administered as one spray in each nostril twice a day, about 12 hours apart. If you miss a dose of Tyrvaya, simply resume at the next scheduled time.

  • Tablets: Generally started about one week before your quit date (or your prescriber may set a flexible quit window); a gradual quitting approach is also an option for those unable to stop abruptly
  • Tyrvaya nasal spray: Twice daily, evenly spaced; prime the pump before first use and re-prime if unused for more than 5 days
  • Dose adjustment of the tablets may be needed if you have severe kidney disease — your prescriber will guide this
🤒Side effects — in detail▾

The most common side effects of varenicline tablets are digestive and sleep-related:

  • Nausea — the most frequent; often mild to moderate and may improve over time
  • Abnormal, vivid, or strange dreams
  • Trouble sleeping (insomnia)
  • Constipation
  • Gas (flatulence)
  • Vomiting
  • Headache
  • Dry mouth

Serious reactions to act on immediately include mood or behavior changes (including suicidal thoughts), seizures, sleepwalking, swelling of the face or throat, and any new skin rash with sores — stop the medication and seek medical care right away if these occur.

⚠️Warnings & precautions▾
  • Mental health changes: Varenicline tablets have been linked to serious mood changes — depression, anxiety, aggression, hallucinations, and suicidal thoughts — in people both with and without a psychiatric history. Caregivers and patients should watch closely and stop the medication and call a doctor immediately if these occur.
  • Seizures: New or worsening seizures have been reported, most often within the first month. Use with caution if you have any history of seizures.
  • Cardiovascular risk: Patients with existing heart disease may face a slightly higher chance of nonfatal heart attack or stroke; however, quitting smoking also significantly benefits heart health. Report any new chest pain or stroke symptoms to your doctor right away.
  • Alcohol interaction: Alcohol may feel much stronger than usual — some people have experienced blackouts or aggressive behavior. Reduce drinking until you know how varenicline affects you.
  • Driving and machinery: Somnolence, dizziness, and difficulty concentrating have been reported. Be careful driving until you know how it affects you.
  • Sleepwalking (somnambulism): Cases of sleepwalking, some involving harmful behavior, have been reported. Stop the medication and tell your doctor if this happens.
  • Serious skin and allergic reactions: Rare but potentially life-threatening reactions — including Stevens-Johnson Syndrome and angioedema (dangerous swelling) — have been reported. Stop immediately and seek emergency care if a rash with mouth sores or throat swelling develops.
🔀What it interacts with▾

Varenicline tablets have no major pharmacokinetic drug interactions (meaning they do not significantly change how most other drugs are processed), but there are important practical interactions to know:

  • Other smoking cessation therapies (nicotine patch, bupropion): Combining these with varenicline has not been proven safe or effective; combining with a nicotine patch caused more side effects and higher dropout rates in studies
  • Alcohol: May be significantly more intoxicating than usual, and unusual or aggressive behavior has been reported — reduce consumption during treatment
  • Theophylline, warfarin, insulin: Quitting smoking itself (not necessarily varenicline) can change how these drugs work in your body; your prescriber may need to adjust those doses after you quit

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▾
  • Do not take varenicline tablets if you have had a serious allergic or skin reaction to varenicline in the past
  • Tell your doctor about any history of depression, bipolar disorder, schizophrenia, or other mental health conditions — varenicline tablets can worsen psychiatric illness in some people
  • Tell your doctor if you have a history of seizures
  • Tell your doctor if you have heart disease — there may be a small increased risk of certain cardiovascular events
  • Tell your doctor if you have kidney disease, especially severe kidney impairment — a dose adjustment of the tablets may be needed
  • Pregnancy: Limited data exist; smoking during pregnancy carries known serious risks to the baby, so discuss the risks and benefits of varenicline with your doctor
  • Breastfeeding: It is unknown whether varenicline passes into breast milk; monitor your infant for seizures or excessive vomiting and consult your doctor
  • Children and teenagers 16 and under: Varenicline tablets are not recommended — they were not shown to be effective in this age group in clinical studies
  • Older adults (65+) generally tolerate varenicline similarly to younger adults, but kidney function should be monitored since varenicline is mainly cleared by the kidneys
🚑If you take too much▾

If an overdose is suspected, standard supportive medical care should be provided — there is no specific antidote. Varenicline can be removed from the body by hemodialysis (a kidney dialysis machine) in patients with kidney failure, though there is no published experience using dialysis specifically after an overdose. Contact a poison control center or seek emergency care immediately if an overdose is suspected.

📡Pharmacodynamics — effects in the body▾

In the brain, varenicline partially activates and simultaneously blocks the α4β2 nicotinic receptors that nicotine targets. This dual action reduces both craving and the rewarding effect of smoking by blunting the dopamine release that reinforces the habit. Because its stimulation of these receptors is significantly weaker than nicotine's, it relieves withdrawal without fully reproducing nicotine's effects. Tyrvaya nasal spray acts on cholinergic pathways in and around the eye to stimulate natural tear production.

🔬Pharmacokinetics — how your body processes it▾

Varenicline tablets are very well absorbed after oral dosing — about 90% reaches the bloodstream — and food does not affect this. Blood levels peak roughly 3–4 hours after a dose, and steady levels are reached within about 4 days of regular dosing. The drug stays active in the body for about 24 hours (its half-life), and 92% of it leaves the body unchanged through the kidneys, with very little broken down by the liver. Because it depends so heavily on kidney filtration, people with severe kidney disease build up higher levels of the drug and may need a lower dose.

📦How to store it▾

Store at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) (see USP Controlled Room Temperature).

📄 Written from Varenicline’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 →

20

Supplements & herbs that interact with Varenicline

20 supplements and herbal products have documented interactions with Varenicline 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 · 1
  • Moderate · 10
  • Minor · 9
ACTIVATED CHARCOAL Major BEER Moderate COFFEE CHARCOAL Moderate EUROPEAN MANDRAKE Moderate GLUCOMANNAN Moderate GUAR GUM Moderate GUM ARABIC Moderate SLIPPERY ELM Moderate +12 more
Every supplement checked against Varenicline — ranked by severity The full interaction hub: 1 major · 10 moderate · 9 minor · every one linked to its full report. Check Varenicline 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.

🩺 Pharmacist Counseling Corner

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

What's the difference between Chantix (or the generic tablets) and Tyrvaya? Are they the same thing? ▾
They both contain varenicline, but they are completely different products used for completely different things. Chantix and the generic tablets are taken by mouth to help you quit smoking. Tyrvaya is a nasal spray approved to treat dry eye disease. The two are not interchangeable, and you should only use whichever one your doctor has specifically prescribed for your condition.
Nausea sounds rough — is it going to be bad the whole time I'm on the tablets? ▾
Nausea is the most common side effect, and it affects a real number of people, but the good news is it's usually mild to moderate and often improves as your body adjusts. Starting at a lower dose in the first week is specifically designed to reduce it. Taking the tablet with food or a full glass of water can also help. If it's truly unbearable, talk to your prescriber — reducing the dose is an option.
I've heard varenicline can affect your mental health. Should I be worried? ▾
This is worth taking seriously. Some people taking varenicline tablets have experienced mood changes, depression, anxiety, and — in rare cases — thoughts of self-harm. This can happen even in people without a history of mental health problems. It's important that someone close to you knows you're on this medication so they can watch for changes you might not notice yourself. If anything feels off — unusual irritability, feeling very low, or any thought of hurting yourself — stop the medication and contact your doctor or go to the ER right away. The benefits of quitting smoking are real, but your mental health has to be monitored during treatment.
Can I drink alcohol while taking the tablets? ▾
You should be very careful. Alcohol can feel much stronger than usual when you're taking varenicline, and some people have experienced blackouts or behaved in unusual or aggressive ways they didn't remember afterward. The label recommends cutting back on alcohol — at least until you know how varenicline affects your tolerance. When in doubt, it's safest to avoid alcohol during treatment.
Is it safe to use a nicotine patch or gum at the same time as varenicline tablets? ▾
It's generally not recommended without your doctor's guidance. Studies showed that combining varenicline tablets with a nicotine patch led to more side effects — nausea, headache, vomiting, and dizziness — and many more people stopped treatment early because of it. The safety of combining varenicline with bupropion (Wellbutrin/Zyban) also hasn't been established. Stick to one approach unless your doctor specifically approves a combination.
I'm on warfarin (a blood thinner) — do I need to worry about varenicline interacting with it? ▾
Varenicline itself doesn't directly interfere with warfarin in a meaningful pharmacological way. However, quitting smoking — which is the whole point — can change how your body processes warfarin, and your levels may shift as you become smoke-free. Let your prescriber and whoever manages your warfarin know you're starting a quit attempt, so they can monitor your blood levels and adjust your dose if needed.
Is Varenicline available over the counter? ▾
Varenicline 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 Varenicline first available? ▾
Varenicline has been available in the United States since at least 2006, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Varenicline? ▾
Varenicline is supplied by 52 manufacturers listed in the FDA NDC Directory, including Apotex Corp, A-S Medication Solutions, Leading Pharma, LLC.

💬 Answers drafted from Varenicline’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

📊Varenicline supplement interactions20 checked — ranked by severity 🌿Drug & Supplement CheckerVarenicline vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Varenicline NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Varenicline comes

Varenicline 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.

Tablet

By mouth
Brands Apo-varenicline Chantix
How this form is used
What it may be used for
  • Chantix tablets are indicated as an aid to smoking cessation treatment in adults
  • Varenicline and Varenicline Tartrate tablets are indicated as an aid to smoking cessation treatment in adults
Important instructions
  • Chantix and varenicline tablets are taken by mouth, typically twice daily after a starting period of once-daily dosing; follow your prescriber's exact schedule
  • Treatment is usually started about one week before your planned quit date, or your doctor may have you set a quit date within the first 5 weeks of treatment
  • Tablets can be taken with or without food — food does not change how well they are absorbed
  • An additional course of treatment beyond the initial 12 weeks may be recommended by your prescriber to help maintain abstinence
Available strengths 5 strengths
0.5 mg 0.5 mg/561 1 mg 1 mg/561 1 kg/kg
107 FDA-listed product records ⓘ

Nasal spray

In the nose
Brands Tyrvaya
How this form is used
What it may be used for
  • Tyrvaya nasal spray is indicated for the treatment of the signs and symptoms of dry eye disease
Important instructions
  • Tyrvaya is sprayed once into each nostril twice daily, approximately 12 hours apart
  • Before using Tyrvaya for the first time, prime the pump with 7 sprays into the air, away from your face
  • If Tyrvaya has not been used for more than 5 days, re-prime with 1 spray into the air before using
  • If you miss a dose of Tyrvaya, resume your regular schedule at the next scheduled dose time — do not double up
Available strengths 1 strength
0.03 mg/0.05 mL
4 FDA-listed product records ⓘ

📊 Varenicline across the U.S. market

How Varenicline 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 ⓘ
52
Manufacturers
5
Brand names
159
FDA-listed product records ⓘ
2006
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.

Also listed with the FDA, not a patient dose form: Kit (34) · Powder (14) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Apotex Corp7%
A-S Medication Solutions7%
Leading Pharma, LLC4%
Pfizer Laboratories Div Pfizer Inc4%
Par Pharmaceutical, Inc.4%
Glenmark Pharmaceuticals Inc., USA4%
Other makers69%

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

📈 How widely Varenicline is used

A general measure of how commonly Varenicline 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 Varenicline 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.

417,684
Medicaid prescriptions filled (Q1–Q4 2025)
$33.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Varenicline prescribed? Of the 1,596 medications we measure, Varenicline ranks #283 by Medicaid prescriptions — more than 82% of them.

Where Varenicline ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #283 of 1,596
#278 Ziprasidone 438,206 Rx #279 Ciclopirox Topical 437,507 Rx #280 Diltiazem 435,096 Rx #281 Warfarin 433,961 Rx #282 Acetaminophen, Butalbi... 425,589 Rx #283 Varenicline 417,684 Rx #284 Human Insulin Injectio... 414,373 Rx #285 Loperamide 409,237 Rx #286 Tacrolimus Topical 408,485 Rx #287 Cyclosporine 403,927 Rx #288 Betamethasone 403,381 Rx

Utilization by Varenicline 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 1 mg oral tablet is the most-dispensed Varenicline product — about 60% of these Medicaid prescriptions.

varenicline 1 MG Oral Tablet Most dispensed

251,780 Medicaid prescriptions (Q1–Q4 2025) 60% of Varenicline prescriptions shown $17.6M gross reimbursement (before rebates) ≈ $70 per prescription (gross)

Summed across the 14 of 49 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 636676

varenicline 0.5 MG Oral Tablet

33,415 Medicaid prescriptions (Q1–Q4 2025) 8% of Varenicline prescriptions shown $1.9M gross reimbursement (before rebates) ≈ $58 per prescription (gross)

Summed across the 13 of 39 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 636671

varenicline 0.03 MG/ACTUAT Nasal Spray

8,153 Medicaid prescriptions (Q1–Q4 2025) 2% of Varenicline prescriptions shown $5.6M gross reimbursement (before rebates) ≈ $686 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2572365

Other Varenicline products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

124,336 Medicaid prescriptions (Q1–Q4 2025) 30% of Varenicline prescriptions shown $7.9M gross reimbursement (before rebates) ≈ $64 per prescription (gross)

Summed across the 13 of 64 listed NDC products with Medicaid activity.

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 Varenicline, 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 41 of 155 listed Varenicline NDCs with Medicaid activity.

🔍 Compare Varenicline products

A representative set of FDA-listed product records for Varenicline — 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 159 of 159 products — FDA National Drug Code Directory. See every product, package size and price: browse all 159 Varenicline 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) Varenicline RxCUI 591622 2 dose forms · 3 strengths
  1. Dose form (SCDF) Nasal Spray RxCUI 2572364 In current FDA listings
    Clinical drug / strength (SCD) 0.03 MG/ACTUAT RxCUI 2572365
  2. Dose form (SCDF) Oral Tablet RxCUI 636670 In current FDA listings
    Clinical drug / strength (SCD) 0.5 MG RxCUI 636671 1 MG RxCUI 636676

Look up RxCUI 591622 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

Chantix Tyrvaya Apo-varenicline

🏭 Manufacturers & labelers

Apotex Corp 11 A-S Medication Solutions 10 Leading Pharma, LLC 6 Pfizer Laboratories Div Pfizer Inc 6 Par Pharmaceutical, Inc. 6 Glenmark Pharmaceuticals Inc., USA 6 AvKARE 6 Ajanta Pharma USA Inc. 6 Ascend Laboratories, LLC 6 Umedica Laboratories USA Inc. 5 Lupin Pharmaceuticals, Inc. 5 Bryant Ranch Prepack 4 Zydus Pharmaceuticals USA Inc. 4 Golden State Medical Supply, Inc. 4 Dr. Reddys Laboratories Inc. 4 Macleods Pharmaceuticals Limited 3 Nivagen Pharmaceuticals Inc. 3 Camber Pharmaceuticals, Inc. 3 Micro Labs Limited 3 NorthStar RxLLC 3 Major Pharmaceuticals 3 Pfizer Labs, Division of Pfizer Inc. 3 Par Health USA, LLC 3 American Health Packaging 3

…and 16 more on the FDA NDC directory.

RxNorm drug class

Varenicline belongs to the Partial Cholinergic Nicotinic Agonist class.

Pharmacologic class Partial Cholinergic Nicotinic Agonist, Cholinergic Receptor Agonist
Drug family (ATC) Drugs used in nicotine dependence, Other ophthalmologicals
How it works Cholinergic Agonists, Partial Cholinergic Nicotinic Agonists

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 Apr 15, 2023
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Varenicline.
📈
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 Varenicline after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
40
NDC products indexed
159
Distinct labelers/manufacturers represented
52
Linked representative label ⓘ
Mylan Pharmaceuticals Inc.
Linked label effective
Apr 15, 2023
Composite sections available
24
Linked SPL Set ID
4233fb78-ac6c-49f3-aad8-7e4bee18cac6
Linked SPL Document ID
5b7b6e3b-f427-4000-b252-968f3adbaa3b
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 40 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. Mylan 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.