FDA-filed SPL labeling · retrieved through openFDA

Doxepin

Doxepin is a prescription sleep aid used to help adults who wake up and can't stay asleep.

Brand names PrudoxinZonalonSilenor
Drug class ⓘ Tricyclic Antidepressant
Rx Forms 4 Routes Oral · Topical
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 105 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 8, 2025
Clinical labels in scope ⓘ105
AvailabilityRx
Earliest approval/marketing year ⓘ1969
FDA-listed product records ⓘ497
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 18, 2026 🚨Recall on record
Other forms & routes:
Topical
⭐ Doxepin at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Doxepin tablets are a low-dose sleep medication for adults who struggle to stay asleep through the night. Take it on an empty stomach and only when you have a full night ahead of you. Keep your doctor informed if you notice any mood changes, difficulty urinating, or unusual side effects — and never combine it with MAOI medications.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Important warning: doxepin and the risk of suicidal thoughts in young people. Antidepressants, including doxepin, have been shown to increase the risk of suicidal thinking and behavior in children, teenagers, and young adults (particularly those under 25). This risk appeared in short-term studies. Doxepin tablets are not approved for use in anyone under 18. All patients — especially younger adults — taking doxepin should be monitored closely for any worsening of mood, new or increased thoughts of suicide, or unusual changes in behavior. If you or someone you know notices these signs, contact a healthcare provider immediately.

Read the full warning on DailyMed →

📖 Doxepin: Patient Information Guide

A plain-language walkthrough of Doxepin — 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▾

Doxepin tablets are prescribed to treat insomnia in adults — specifically when the main problem is staying asleep.

  • Sleep maintenance insomnia — waking up during the night or too early and being unable to fall back asleep
⚙️How it works▾

The exact way doxepin promotes sleep isn't fully known, but the leading explanation is that it blocks the brain's H1 histamine receptor. Histamine is a chemical that helps keep you awake and alert. By blocking this receptor very strongly, doxepin essentially quiets the wake signal in your brain, helping you stay asleep longer. This is the same basic mechanism as older antihistamines that cause drowsiness — but at a much lower, targeted dose.

💊How it's taken▾

Doxepin is taken by mouth as a tablet. Your prescriber will choose the right dose and schedule for you. A few important rules to follow:

  • Do not take it within 3 hours of eating — food slows how fast it works and can increase morning grogginess
  • Take it only when you're ready for bed and can get a full night of sleep
  • If you miss a dose, skip it — never double up the next night
  • Do not stop suddenly after long-term use; your doctor will help you taper off gradually
🤒Side effects — in detail▾

Most people tolerate doxepin well at the low doses used for sleep. The most commonly reported side effects include:

  • Drowsiness or sedation — sometimes carrying into the next morning
  • Nausea
  • Upper respiratory infection symptoms (runny nose, mild cold symptoms)

More serious reactions — such as signs of serotonin syndrome (agitation, fever, muscle twitching), thoughts of self-harm, difficulty urinating, or manic behavior — require prompt medical attention. Contact your doctor or seek emergency care if these occur.

⚠️Warnings & precautions▾

Suicidal thoughts in young adults: Like all antidepressants, doxepin carries a boxed warning about increased risk of suicidal thinking and behavior in people under 25. All patients should be monitored for mood changes, worsening symptoms, or new thoughts of self-harm — especially early in treatment.

  • Serotonin syndrome: A potentially life-threatening reaction if doxepin is combined with other drugs that raise serotonin. Symptoms include agitation, rapid heart rate, fever, and muscle jerking.
  • Driving and alertness: Doxepin causes sedation. Avoid driving or operating dangerous equipment until you know how it affects you.
  • Mania/Bipolar risk: Doxepin can trigger a manic episode in people with bipolar disorder. Screening for bipolar history is recommended before starting.
  • Angle-closure glaucoma: Doxepin should be avoided in people with untreated narrow-angle glaucoma.
🔀What it interacts with▾

Doxepin can interact with a number of medications and substances. Key ones to know:

  • MAOIs (e.g., linezolid, phenelzine, selegiline, IV methylene blue) — combining these can cause dangerous, potentially fatal reactions; a 14-day washout period is required on both sides
  • Other serotonergic drugs (medications that raise serotonin) — risk of serotonin syndrome increases
  • Strong CYP2D6 inhibitors — can raise doxepin blood levels, increasing side effect risk; a dose adjustment may be needed
  • Carbamazepine — lowers doxepin levels, possibly reducing effectiveness
  • Cimetidine (OTC heartburn medication) — can roughly double doxepin levels in the blood
  • Alcohol and sedating substances — amplify the drowsiness caused by doxepin

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▾
  • Allergy to doxepin or dibenzoxepines — do not take if you've had a reaction to these
  • Untreated narrow-angle glaucoma — contraindicated; tell your doctor if you have glaucoma
  • Severe urinary retention — contraindicated; discuss any prostate or bladder issues with your doctor
  • Bipolar disorder or family history of mania — must be screened before starting
  • Pregnancy — third-trimester use has been linked to newborn adaptation problems; discuss risks with your doctor
  • Breastfeeding — not recommended; talk to your doctor about alternatives
  • Children and teenagers — not approved for use in anyone under 18
  • Older adults — should start at a lower dose and be monitored carefully before any increase
  • Liver problems or tendency toward urinary retention — a lower starting dose is advised
🚑If you take too much▾

Taking too much doxepin can cause serious effects, including confusion, hallucinations, seizures, severe low blood pressure, and dangerous heart rhythm problems. In critical overdose, coma is possible. If you suspect an overdose, call Poison Control (1-800-222-1222) or go to an emergency room immediately — and bring the medication bottle with you.

📡Pharmacodynamics — effects in the body▾

Doxepin binds very strongly to the H1 histamine receptor in the brain — one of the signals that keeps you awake. By blocking this receptor, it reduces wakefulness during the night. In clinical testing, doxepin at doses used for sleep did not affect the heart's electrical activity (QT interval), which is reassuring from a cardiac safety standpoint.

🔬Pharmacokinetics — how your body processes it▾

After taking doxepin by mouth, it typically reaches peak levels in the blood around 3.5 hours when taken on an empty stomach. Eating a high-fat meal before taking it delays that peak by about 3 hours and increases overall exposure — which is why it's recommended to take it at least 3 hours after your last meal. Doxepin is broken down mainly by liver enzymes (CYP2D6 and CYP2C19), and its half-life — the time it takes your body to clear half the drug — is about 15 hours. Its main breakdown product, nordoxepin, stays in the body even longer (around 31 hours), which can contribute to morning grogginess if levels build up.

📦How to store it▾

Store at 20°C to 25°C (68°F to 77°F) , protected from light. Dispense in a tight, light resistant container.

📄 Written from Doxepin’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 Doxepin — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is doxepin being used for here? I thought it was an antidepressant. ▾
Good question — doxepin does have a history as an antidepressant, but what you're being prescribed is a much lower-dose version specifically approved for sleep. It's used for people who fall asleep okay but keep waking up through the night. At this low dose, it works mainly by calming the brain's 'stay awake' signal, not as an antidepressant.
Does it matter when I take it or if I eat first? ▾
Yes, timing really does matter. You should take doxepin at least 3 hours after your last meal — especially if that meal was high in fat. Eating close to your dose makes the medication absorb more slowly and can make you feel groggy the next morning. Take it right when you're getting into bed, and make sure you have the whole night ahead of you.
Will I feel tired the next day? ▾
Drowsiness is the most common side effect, and yes, it can carry into the morning — especially when you first start. That's why it's important not to drive or operate machinery until you know how doxepin affects you. Taking it on an empty stomach and at the right time helps reduce that next-day grogginess.
I saw a warning about suicidal thoughts — should I be worried? ▾
That warning is on all antidepressant medications and is required by the FDA. The main concern is for people under 25. At the low doses used for sleep, this risk is less established — but it's still something to be aware of. If you notice any changes in your mood, feel more anxious or agitated, or have any thoughts of harming yourself, contact your doctor or go to an emergency room right away. The warning exists so that you know what to watch for, not to scare you away from a medication your doctor has prescribed.
Are there any medications I absolutely cannot take with this? ▾
The most important one to avoid is any MAOI-type medication — these include certain antidepressants and some other drugs. Combining them with doxepin can be very dangerous, even life-threatening. You need at least a 14-day gap between an MAOI and doxepin in either direction. Also avoid alcohol while taking doxepin — it significantly increases the sedating effect. Be sure to give your pharmacist a full list of everything you take, including over-the-counter products like cimetidine for heartburn.
Is it safe to take if I'm pregnant or breastfeeding? ▾
If you're pregnant, especially in the third trimester, doxepin may cause adaptation problems in the newborn — things like breathing difficulties or feeding issues right after delivery. It's not recommended while breastfeeding either. Talk to your doctor as soon as possible so you can weigh the risks and explore safer options together.
Is Doxepin available over the counter? ▾
Doxepin 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 Doxepin first available? ▾
Doxepin has been available in the United States since at least 1969, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Doxepin? ▾
Doxepin is supplied by 73 manufacturers listed in the FDA NDC Directory, including Remedyrepack Inc., Bryant Ranch Prepack, Ajanta Pharma USA Inc..

💬 Answers drafted from Doxepin’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

🌿Drug & Supplement CheckerDoxepin vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Doxepin NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Doxepin comes

Doxepin is available in 4 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 Silenor
Available strengths 2 strengths
3 mg 6 mg
76 FDA-listed product records ⓘ

Topical cream, ointment or gel

On the skin
Brands Prudoxin Zonalon
Available strengths 1 strength
50 mg/g
6 FDA-listed product records ⓘ

Oral solution

By mouth
Available strengths 1 strength
10 mg/mL
4 FDA-listed product records ⓘ

📊 Doxepin across the U.S. market

How Doxepin 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.

4
Dose forms ⓘ
73
Manufacturers
6
Brand names
497
FDA-listed product records ⓘ
1969
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: Powder (9) · Crystal (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Remedyrepack Inc.12%
Bryant Ranch Prepack8%
Ajanta Pharma USA Inc.4%
Amneal Pharmaceuticals NY LLC4%
Mylan Pharmaceuticals Inc.4%
Leading Pharma, LLC4%
Other makers63%

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

📈 How widely Doxepin is used

A general measure of how commonly Doxepin 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 Doxepin 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.

628,470
Medicaid prescriptions filled (Q1–Q4 2025)
$30.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Doxepin prescribed? Of the 1,596 medications we measure, Doxepin ranks #233 by Medicaid prescriptions — more than 85% of them.

Where Doxepin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #233 of 1,596
#228 Rivaroxaban 655,610 Rx #229 Polymyxin B and Trimet... 651,823 Rx #230 Magnesium Oxide 648,844 Rx #231 Alendronate 645,853 Rx #232 Glimepiride 630,394 Rx #233 Doxepin (Insomnia) 628,470 Rx #234 Doxepin (Depression, A... 628,470 Rx #235 Doxepin 628,470 Rx #236 Ropinirole 626,420 Rx #237 Valsartan 609,824 Rx #238 Testosterone Injection 605,127 Rx

Utilization by Doxepin 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 10 mg oral capsule is the most-dispensed Doxepin product — about 30% of these Medicaid prescriptions.

doxepin 10 MG Oral Capsule Most dispensed

189,409 Medicaid prescriptions (Q1–Q4 2025) 30% of Doxepin prescriptions shown $2.2M gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 16 of 95 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000048

doxepin 25 MG Oral Capsule

127,554 Medicaid prescriptions (Q1–Q4 2025) 20% of Doxepin prescriptions shown $1.7M gross reimbursement (before rebates) ≈ $14 per prescription (gross)

Summed across the 14 of 113 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000070

doxepin 50 MG Oral Capsule

108,904 Medicaid prescriptions (Q1–Q4 2025) 17% of Doxepin prescriptions shown $1.6M gross reimbursement (before rebates) ≈ $14 per prescription (gross)

Summed across the 14 of 82 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000076

doxepin 100 MG Oral Capsule

67,651 Medicaid prescriptions (Q1–Q4 2025) 11% of Doxepin prescriptions shown $1.3M gross reimbursement (before rebates) ≈ $20 per prescription (gross)

Summed across the 13 of 52 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000058

doxepin hydrochloride 50 MG/ML Topical Cream

36,950 Medicaid prescriptions (Q1–Q4 2025) 6% of Doxepin prescriptions shown $19.6M gross reimbursement (before rebates) ≈ $530 per prescription (gross)

Summed across the 6 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000091

doxepin 150 MG Oral Capsule

29,510 Medicaid prescriptions (Q1–Q4 2025) 5% of Doxepin prescriptions shown $823,737 gross reimbursement (before rebates) ≈ $28 per prescription (gross)

Summed across the 5 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000064

doxepin 75 MG Oral Capsule

27,128 Medicaid prescriptions (Q1–Q4 2025) 4% of Doxepin prescriptions shown $500,793 gross reimbursement (before rebates) ≈ $18 per prescription (gross)

Summed across the 12 of 45 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000097

doxepin 10 MG/ML Oral Solution

14,180 Medicaid prescriptions (Q1–Q4 2025) 2% of Doxepin prescriptions shown $526,403 gross reimbursement (before rebates) ≈ $37 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000054

doxepin 3 MG Oral Tablet

13,865 Medicaid prescriptions (Q1–Q4 2025) 2% of Doxepin prescriptions shown $1.3M gross reimbursement (before rebates) ≈ $97 per prescription (gross)

Summed across the 8 of 43 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 966787

doxepin 6 MG Oral Tablet

13,319 Medicaid prescriptions (Q1–Q4 2025) 2% of Doxepin prescriptions shown $1.2M gross reimbursement (before rebates) ≈ $94 per prescription (gross)

Summed across the 8 of 48 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 966793

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 Doxepin, 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 97 of 501 listed Doxepin NDCs with Medicaid activity.

🔍 Compare Doxepin products

A representative set of FDA-listed product records for Doxepin — 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 200 of 497 products — FDA National Drug Code Directory. See every product, package size and price: browse all 497 Doxepin 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) Doxepin RxCUI 3638 4 dose forms · 10 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 371962 In current FDA listings
    Clinical drug / strength (SCD) 10 MG RxCUI 1000048 25 MG RxCUI 1000070 50 MG RxCUI 1000076 75 MG RxCUI 1000097 100 MG RxCUI 1000058 150 MG RxCUI 1000064
  2. Dose form (SCDF) Oral Solution RxCUI 379135 In current FDA listings
    Clinical drug / strength (SCD) 10 MG/ML RxCUI 1000054
  3. Dose form (SCDF) Oral Tablet RxCUI 375040 In current FDA listings
    Clinical drug / strength (SCD) 3 MG RxCUI 966787 6 MG RxCUI 966793
  4. Dose form (SCDF) Topical Cream RxCUI 377691 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 50 MG/ML RxCUI 1000091

Look up RxCUI 3638 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

Prudoxin Zonalon Silenor

🏭 Manufacturers & labelers

Remedyrepack Inc. 54 Bryant Ranch Prepack 37 Ajanta Pharma USA Inc. 19 Amneal Pharmaceuticals NY LLC 17 Mylan Pharmaceuticals Inc. 17 Leading Pharma, LLC 17 Novadoz Pharmaceuticals LLC 16 PD-Rx Pharmaceuticals, Inc. 16 Epic Pharma, LLC 13 Mylan Institutional Inc. 12 Aurobindo Pharma Limited 12 Golden State Medical Supply, Inc. 11 Micro Labs Limited 10 First Nation Group, LLC 10 Chartwell RX, LLC 10 Rising Pharma Holdings, Inc. 10 Lifestar Pharma LLC 10 Alembic Pharmaceuticals Limited 10 Alembic Pharmaceuticals Inc. 10 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 9 Direct_Rx 9 Lannett Company, Inc. 8 Major Pharmaceuticals 8 Actavis Pharma, Inc. 8

…and 16 more on the FDA NDC directory.

RxNorm drug class

Doxepin belongs to the Tricyclic Antidepressant class.

Pharmacologic class Tricyclic Antidepressant
Drug family (ATC) Other antipruritics, Non-selective monoamine reuptake 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 8, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Doxepin.
📈
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 Doxepin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
105
NDC products indexed
497
Distinct labelers/manufacturers represented
73
Linked representative label ⓘ
Viona Pharmaceuticals Inc
Linked label effective
Jan 8, 2025
Composite sections available
27
Linked SPL Set ID
3377541d-db46-4fd9-9a4b-faa5f6108e67
Linked SPL Document ID
d569143c-aee2-4e03-988d-1ef10950e7ce
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 105 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. Viona 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.