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Elinzanetant

Elinzanetant is a once-daily bedtime capsule that treats moderate to severe hot flashes and night sweats (vasomotor symptoms) caused by menopause.

Brand name Lynkuet
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Aug 25, 2026 Content updated Oct 8, 2026
🧬 Where this information comes from

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set 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 →

✓No current FDA shortage listed · checked Oct 8, 2026
Elinzanetant at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Lynkuet (elinzanetant) is a nightly capsule for moderate to severe menopausal hot flashes and night sweats that blocks two brain signals (NK1 and NK3) tied to temperature control. It is a newer non-hormonal option, on the market since about 2025 and not yet available as a generic, and is often considered when hormone therapy is not a good fit. Most people tolerate it fairly well, with sleepiness, tiredness, dizziness and headache the effects noticed most, so skip driving if you feel groggy. Watch above all for liver injury, stopping it and calling your prescriber right away for yellow skin or eyes, dark urine, pale stools, itching or belly pain.

Clinical pearls

  • If you could become pregnant, expect a pregnancy test first and effective birth control through 2 weeks after stopping.
  • Expect liver blood tests before starting and about 3 months in, and mention any seizure history, since seizures have been reported.
  • Avoid grapefruit and grapefruit juice, and have new medicines checked, since many drugs shift its levels and it can raise theirs.
  • Swallow capsules whole at bedtime; if you miss a night, just take the next dose the following night, never doubling.
How you get itPrescription only
Comes asCapsule
Earliest FDA record2025
Companies listing it with the FDA1
FDA label last updatedJun 16, 2026
FDA’s strongest warning (boxed)None on the label

Patient Information Guide A plain-language walkthrough of Elinzanetant, written from its FDA label.

What Elinzanetant Is Used For

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Elinzanetant is used for menopause-related hot flashes.

  • Lynkuet (oral capsule) treats moderate to severe vasomotor symptoms due to menopause.

How Elinzanetant Works

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Elinzanetant blocks NK1 and NK3 receptors, which are docking sites for the brain chemicals Substance P and Neurokinin B. These chemicals act on nerve cells (KNDy neurons) involved in body temperature control. Blocking them can modulate that activity and reduce hot flashes.

Elinzanetant Dosage

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Lynkuet is a capsule taken by mouth once a day at bedtime, at about the same time each night.

  • Take it with or without food.
  • Swallow whole with water. Do not cut, crush or chew.
  • If you miss a dose, skip it and take the next one the following day. Do not double up.
  • Your prescriber may lower the dose if you take certain other medicines.

Dosing details from the FDA-approved label

From the Elinzanetant prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Recommended dosage (general)
    • 120 mg (two 60 mg capsules) orally once daily at bedtime at about the same time each day, with or without food, with water
    • Swallow capsules whole
    • If a dose is missed at bedtime, take the next dose as scheduled the following day; do not take two doses on the same day. Do not cut, crush or chew capsules.
  • Concomitant use with moderate CYP3A4 inhibitors
    • 60 mg (one capsule) orally once daily at bedtime
    • After discontinuation of the moderate CYP3A4 inhibitor (after 3 to 5 half-lives of the inhibitor), use the usual dosage of 120 mg once daily
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION The recommended dosage is 120 mg (two 60 mg capsules) orally once daily at bedtime with or without food. ( 2.2 ) Swallow capsules whole. Do not cut, crush, or chew capsules. ( 2.2 ) See full prescribing information for LYNKUET dosage modification due to drug interactions. ( 2.3 ) 2.1 Recommended Evaluation and Testing Before Initiation of LYNKUET Exclude pregnancy in females of reproductive potential [see Contraindications (4) ], Warnings and Precautions (5.3) , and Use in Specific Populations (8.3) ]. Perform baseline hepatic laboratory tests to evaluate for hepatic function and injury [including serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST), serum alkaline phosphatase (ALP), and serum bilirubin (total and direct)] before initiating treatment with LYNKUET. Do not start LYNKUET if ALT or AST is ≥ 2 times upper limit of normal (ULN) or if the total bilirubin is ≥ 2 times ULN [see Warnings and Precautions (5.2) and Use in Specific Populations (8.7) ] . 2.2 Recommended Dosage The recommended dosage of LYNKUET is 120 mg (two 60 mg capsules) orally once daily at bedtime at about the same time each day. If a dose is missed at bedtime, take the next dose as scheduled on the following day. Do not take two doses on the same day to make up for a missed dose. Take LYNKUET with or without food. Take LYNKUET with water and swallow capsules whole. Do not cut, crush or chew capsules. 2.3 Dosage Modifications for Drug Interactions Dosage modifications for concomitant use with specific drugs are provided in Table 1 [see Drug Interactions (7.1) ]. Table 1: Dosage Modifications for Drug Interactions Concomitant Drug LYNKUET Dosage Strong CYP3A4 inhibitors and grapefruit (juice) Avoid concomitant use Moderate CYP3A4 inhibitors 60 mg (one capsule) orally once daily at bedtime [see Storage and Handling (16.2) ]. After discontinuation of the moderate CYP3A4 inhibitor (after 3 to 5 half-lives of the inhibitor), LYNKUET should be used at the usual dosage of 120 mg once daily. Strong and Moderate CYP3A4 inducers Avoid concomitant use

Read the full Dosage and Administration section on DailyMed →

Elinzanetant Side Effects

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The most common side effects in studies were:

Common side effects

  • Headache
  • Fatigue
  • Dizziness
  • Sleepiness (somnolence)
  • Nausea
  • Acid reflux (gastroesophageal reflux disease)
  • Abdominal pain
  • Diarrhea
  • Rash
  • Muscle spasms

When to get medical help

  • Stop the medicine and call your doctor right away if you have signs of liver injury: new tiredness, loss of appetite, nausea, vomiting, itching, yellow skin or eyes, pale stools, dark urine, or belly pain.
  • Call your doctor if you have a seizure.
  • Tell your doctor right away if you become pregnant or think you might be.
  • Avoid driving or hazardous activities if you feel sleepy, dizzy or lightheaded until it passes.

Call your doctor about signs of liver injury or a seizure. Pause driving if you feel drowsy or dizzy.

Elinzanetant Warnings and Precautions

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  • Pregnancy loss: contraindicated in pregnancy. Pregnancy must be excluded before starting, and stop if you become pregnant.
  • Liver effects: blood tests before starting and about 3 months later. Stop right away if you have symptoms of liver injury.
  • Seizures: reported in patients taking it. Use caution if you have a history of seizures.
  • Drowsiness and daytime impairment: avoid driving or hazardous activities until effects pass.

Elinzanetant Interactions

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Lynkuet is mainly broken down by the CYP3A4 enzyme, so drugs affecting it matter.

  • Strong CYP3A4 inhibitors and grapefruit (juice): avoid, as they raise Lynkuet levels.
  • Moderate CYP3A4 inhibitors: lower Lynkuet dose needed.
  • Strong and moderate CYP3A4 inducers: avoid, as they may make it less effective.
  • CYP3A4 substrate drugs: Lynkuet can raise their levels, so avoid combining unless advised.

Interactions listed in the FDA-approved label

From the Elinzanetant prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong CYP3A4 inhibitors and grapefruit (juice): Strong and moderate CYP3A4 inhibitors increase elinzanetant exposure, which may increase the risk of LYNKUET-associated adverse reactions. Avoid concomitant use.
  • Moderate CYP3A4 inhibitors: Strong and moderate CYP3A4 inhibitors increase elinzanetant exposure, which may increase the risk of LYNKUET-associated adverse reactions. Reduce LYNKUET dosage to 60 mg once daily.
  • Strong and moderate CYP3A4 inducers: Strong and moderate CYP3A4 inducers decrease elinzanetant exposure, which may reduce the effectiveness of LYNKUET. Avoid concomitant use.
  • CYP3A4 substrates: Elinzanetant is a weak inhibitor of CYP3A4; concomitant use increases exposure of CYP3A4 substrates, which may increase the risk of adverse reactions related to these substrates. Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP3A4 substrates where minimal concentration changes may lead to serious adverse reactions.
Read the label’s full interactions text

7 DRUG INTERACTIONS Strong CYP3A4 Inhibitors and grapefruit (juice): Avoid concomitant use with LYNKUET. ( 7.1 ) Moderate CYP3A4 Inhibitors: Reduce LYNKUET dosage to 60 mg once daily. ( 2.3 , 7.1 )21 Strong and Moderate CYP3A4 Inducers: Avoid concomitant use with LYNKUET. ( 7.1 ) 7.1 Effects of Other Drugs on LYNKUET Elinzanetant is primarily metabolized via CYP3A4 enzyme. Table 3 describes drug interactions where concomitant use of another drug affects LYNKUET. Table 3: Drug Interactions: Concomitant Use of Other Drugs Affect the Use of LYNKUET Strong and Moderate CYP3A4 Inhibitors See www.fda.gov/CYPandTransporterInteractingDrugs for examples of strong and moderate CYP3A4 inhibitors, and CYP3A4 inducers. Prevention or Management Strong CYP3A4 Inhibitors and grapefruit (juice): Avoid concomitant use. Moderate CYP3A4 Inhibitors: Reduce the LYNKUET dosage [see Dosage and Administration (2.2) ]. Clinical Effect(s) Strong and moderate CYP3A4 inhibitors increase elinzanetant exposure, which may increase the risk of LYNKUET-associated adverse reactions [see Clinical Pharmacology (12.3) ]. Strong and Moderate CYP3A4 Inducers Prevention or Management Strong and moderate CYP3A4 inducers: Avoid concomitant use. Clinical Effect(s) Strong and moderate CYP3A4 inducers decrease elinzanetant exposure, which may reduce the effectiveness of LYNKUET. 7.2 Effects of LYNKUET on Other Drugs CYP3A4 Substrates Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP3A4 substrates where minimal concentration changes may lead to serious adverse reactions. See www.fda.gov/CYPandTransporterInteractingDrugs for examples of CYP3A4 substrates. Elinzanetant is a weak inhibitor of CYP3A4. Concomitant use of LYNKUET increases exposure of CYP3A4 substrates [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions related to these substrates.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before Taking Elinzanetant

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  • Do not use during pregnancy.
  • Use effective birth control during treatment and for 2 weeks after if you could become pregnant.
  • Not recommended with moderate to severe liver impairment or end-stage kidney disease.
  • Use caution with a history of seizures.
  • Not established for children.
  • Not enough data in women over 65.
  • No human data on breastfeeding.

Elinzanetant Overdose

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There is no specific antidote for Lynkuet. If an overdose happens, the person should be closely monitored. Supportive treatment based on symptoms may be used.

What Elinzanetant Does in the Body

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In testing, single doses up to 5 times the maximum recommended dose did not cause a clinically relevant change in the heart's QTc interval (an electrical timing measure). The effect when taken with strong CYP3A4 inhibitors has not been well studied.

How Your Body Processes Elinzanetant

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Blood levels of elinzanetant rise a bit more than in proportion to the dose. Steady levels are reached in about 5 to 14 days of daily dosing. It is mainly broken down by the CYP3A4 enzyme, which is why certain other drugs change its levels.

How to Store Elinzanetant

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Store at 20°C to 25°C (68°F to 77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F) . Store the remaining capsule in the original blister card in the carton until the next dose.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Elinzanetant: Pharmacist Answers to Common Questions

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

What is Elinzanetant (Lynkuet) used for?

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It treats moderate to severe hot flashes and other vasomotor symptoms caused by menopause. It is a non-hormone capsule that works on brain signals tied to temperature control.

What happens if I miss a dose of Elinzanetant?

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Just skip it and take your next dose at bedtime the following day. Please don't take two doses in one day to catch up.

Can I drive after taking Elinzanetant?

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It can cause sleepiness, dizziness and fatigue. If you feel any of these, avoid driving or hazardous activities until they go away.

Can I drink grapefruit juice with Elinzanetant?

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No. Grapefruit juice raises the level of the medicine in your body and may increase side effects. Several other medicines also interact, so check with me before starting anything new.

Do I need blood tests while taking Elinzanetant?

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Yes. You'll have liver blood tests before starting and again about 3 months in. Call your doctor and stop the medicine if you notice yellow skin or eyes, dark urine, pale stools, itching, belly pain or new unusual tiredness.

Is Elinzanetant safe during pregnancy?

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No. It may cause pregnancy loss or stillbirth, so it must not be used in pregnancy. If you could become pregnant, you'll need a negative test first and effective birth control during treatment and for 2 weeks after stopping.

Is Elinzanetant available over the counter?

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No. Elinzanetant is a prescription medicine: every Elinzanetant product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Elinzanetant first available?

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The earliest FDA record we hold for Elinzanetant is from 2025: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Elinzanetant was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More About Elinzanetant on HelloPharmacist

Detailed Data & References for Elinzanetant Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Elinzanetant Forms and Strengths (How It Comes)

Elinzanetant 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.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Elinzanetant inactive ingredients by manufacturer.

Capsule

By mouth
Brands Lynkuet
How this form is used
What it may be used for
  • Lynkuet is used to treat moderate to severe vasomotor symptoms due to menopause.
Important instructions
  • Lynkuet is taken by mouth once daily at bedtime, with or without food.
  • Swallow Lynkuet capsules whole with water. Do not cut, crush or chew them.
  • If you miss a Lynkuet dose, take the next dose the following day. Do not take two doses on the same day.
Available strengths 1 strength
2 FDA-listed product records ⓘ

Elinzanetant on the U.S. Market: Products, Makers and Brands

How Elinzanetant 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 company lists 1 Elinzanetant product record with the FDA, mostly as capsule; the earliest marketing or approval year on record is 2025. Brand names on the directory include Lynkuet; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
1
FDA-listed product records ⓘ
2025
Earliest FDA record ⓘ

How Widely Elinzanetant Is Used (Medicaid Data)

A general measure of how commonly Elinzanetant is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q4 2025 – Q1 2026, summed across every form and brand of the drug.

Think of this as a proxy for how widely Elinzanetant 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.

204
Medicaid prescriptions filled (Q4 2025 – Q1 2026)
$133,072 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Elinzanetant prescribed? Of the 1,603 medications we measure, Elinzanetant ranks #1,447 by Medicaid prescriptions — more than 10% of them.

Where Elinzanetant ranks among the drugs we measure · Q4 2025 – Q1 2026 · neighbors ±5

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Elinzanetant, 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 1 of 3 listed Elinzanetant NDCs with Medicaid activity.

Compare Elinzanetant Products

A representative set of FDA-listed product records for Elinzanetant — 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.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Capsule
60 mg Oral Bayer HealthCare Pharmaceuticals Inc. NDA View NDC →

Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Elinzanetant NDCs →

Elinzanetant Recall History

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Elinzanetant recalls since July 2021.

✅No Elinzanetant recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Oct 8, 2026.

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) Elinzanetant RxCUI 2725511 1 dose form · 1 strength
  1. Dose form (SCDF) Oral Capsule RxCUI 2725515 In current FDA listings
    Clinical drug / strength (SCD) 60 MG RxCUI 2725516

Look up RxCUI 2725511 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.

💵 What Elinzanetant Costs Pharmacies (NADAC Benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Capsule · Oral 60 mg $9.97 per capsule NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Elinzanetant Brand Names

Elinzanetant is sold under one brand name in the FDA directory — Lynkuet. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Lynkuet

Who Makes Elinzanetant: Manufacturers and Labelers

One company lists Elinzanetant products with the FDA. By number of product records, the largest are Bayer HealthCare Pharmaceuticals Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bayer HealthCare Pharmaceuticals Inc. 1

Elinzanetant Drug Class (RxNorm)

Elinzanetant belongs to the Other gynecologicals class.

Drug family (ATC) Other gynecologicals

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.

Sources for This Elinzanetant Page

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 Jun 16, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Elinzanetant.
📈
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 Elinzanetant after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
1
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
Bayer HealthCare Pharmaceuticals Inc.
Linked label effective
Jun 16, 2026
Composite sections available
22
Linked SPL Set ID
f42884ff-7dff-419c-8a0c-affe2ed73818
Linked SPL Document ID
35894d94-556e-4bb6-ada9-9d63788de46a
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Bayer HealthCare Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →