FDA-filed SPL labeling · retrieved through openFDA

Megestrol

Megestrol acetate is a progestin medication used to treat appetite loss and significant weight loss in people with AIDS, and to palliatively treat advanced breast or endometrial cancer.

Brand names Megace ESMegace
Drug classes ⓘ Progesterone Congeners
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 21 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 effectiveNov 30, 2022
Clinical labels in scope ⓘ21
AvailabilityRx
Earliest approval/marketing year ⓘ1971
FDA-listed product records ⓘ67
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 18, 2026
⭐ Megestrol at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Megestrol acetate oral suspension is used to boost appetite and treat serious weight loss in people with AIDS, while the tablet form is used to palliate advanced breast or endometrial cancer. Both forms carry important risks including adrenal suppression, blood clots, and elevated blood sugar with long-term use, and neither form should ever be taken during pregnancy. Work closely with your prescriber to monitor for these risks and to make sure you are using the right formulation for your specific condition.
How we write & review this content — our editorial policy →

📖 Megestrol: Patient Information Guide

A plain-language walkthrough of Megestrol — 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▾

Megestrol acetate is approved for two distinct groups of conditions, and the approved use depends on the specific product and formulation.

  • Megestrol Acetate oral suspension: Treats anorexia (loss of appetite), cachexia (severe wasting), or unexplained significant weight loss in patients with a diagnosis of AIDS. It is only used after other treatable causes of weight loss have been identified and addressed, and is not for preventing weight loss.
  • Megestrol Acetate tablets: Used for palliative treatment of advanced carcinoma (cancer) of the breast or endometrium — specifically when the disease is recurrent, inoperable, or metastatic (has spread). Palliative means the goal is to ease symptoms, not cure the disease. Tablets are not intended to replace surgery, radiation, or chemotherapy.
⚙️How it works▾

Megestrol acetate is a synthetic progestin — a lab-made version of the natural hormone progesterone. In people with AIDS-related appetite and weight loss, it has a well-recognized appetite-stimulating effect, though scientists have not yet pinpointed exactly how it triggers that effect. In cancer treatment, it works through hormonal pathways. The drug is absorbed through the gut, with levels peaking in the bloodstream within a few hours of a dose, and is cleared mainly through urine. Its hormonal activity can also affect other body systems — including the body's stress-response hormone axis — which is why long-term use carries additional risks beyond its intended effect.

💊How it's taken▾

How megestrol acetate is taken depends entirely on which product you have been prescribed — do not switch between them on your own.

  • Oral suspension: Taken by mouth once daily. Shake the container well before each use. The 125 mg/mL suspension can be taken with or without food. The 125 mg/mL strength is not interchangeable with the 40 mg/mL strength.
  • Tablets: Taken by mouth in divided doses throughout the day. At least 2 months of continuous use is needed to assess whether the tablets are working for cancer treatment.

Always follow your prescriber's directions and the label on your prescription bottle for exact timing and dosing.

🤒Side effects — in detail▾

The most commonly reported side effects from clinical trials include:

  • Nausea
  • Diarrhea
  • Skin rash
  • Gas (flatulence)
  • High blood pressure
  • Fatigue or weakness (asthenia)
  • Impotence or decreased sex drive
  • Trouble sleeping

More serious reactions — including blood clots, adrenal gland suppression, new or worsening diabetes, and Cushing's syndrome — have been reported with long-term use and require prompt medical attention if signs develop.

⚠️Warnings & precautions▾
  • Adrenal insufficiency: Long-term use can suppress the body's stress-response hormone system (the hypothalamic-pituitary-adrenal axis). This can happen both while taking the medication and after stopping it. Symptoms include dizziness, low blood pressure, nausea, vomiting, and weakness. If unrecognized, this can be fatal. Tell your doctor immediately if you experience these symptoms, especially around surgery or serious illness.
  • Pregnancy: Megestrol acetate can cause serious harm to a developing baby and is contraindicated during pregnancy. Women who could become pregnant must have a negative pregnancy test before starting and must use effective contraception throughout treatment.
  • Blood clots: Cases of deep vein thrombosis (blood clots in the legs), pulmonary embolism (clots in the lungs), and thrombophlebitis (vein inflammation with clotting) have been reported. Use with extra caution if you have a history of blood clotting problems.
  • Diabetes: New-onset diabetes and worsening of pre-existing diabetes have been reported with long-term use. Monitor blood sugar as directed by your doctor.
  • Cushing's syndrome: Chronic use has been linked to this hormonal condition, characterized by weight gain in the face or trunk, easy bruising, and other symptoms of excess cortisol.
🔀What it interacts with▾

Megestrol acetate has a small but important list of drug interactions to be aware of:

  • Warfarin (blood thinner): Megestrol acetate may increase your INR — a measure of blood-clotting time — raising the risk of bleeding. If you take warfarin, your INR will need to be monitored more closely.
  • Indinavir (HIV medication): Taking megestrol acetate together with indinavir can significantly reduce indinavir levels in the blood (by roughly 21–32%), which may make the HIV drug less effective. Talk to your HIV care team about this interaction.
  • Zidovudine and rifabutin: Studies show megestrol acetate does not significantly affect the blood levels of either of these medications.

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 megestrol acetate if you are pregnant — it is contraindicated and can seriously harm the fetus.
  • Do not take it if you have ever had a serious allergic reaction to megestrol acetate or any component of the formulation.
  • Tell your doctor if you have a history of blood clots — use requires caution.
  • Tell your doctor if you have diabetes or are at risk for it, as this drug can raise blood sugar.
  • If you are a woman of childbearing potential, use effective contraception throughout treatment with the oral suspension and get a pregnancy test before starting.
  • Do not breastfeed while taking megestrol acetate — the drug is present in breast milk, and HIV-positive mothers should not breastfeed due to the risk of HIV transmission.
  • Older adults should be started at the lower end of the dosing range and monitored carefully, particularly for kidney function, since the drug is largely cleared through urine.
  • Safety and effectiveness in children have not been established.
  • Women taking the oral suspension should know that breakthrough vaginal bleeding has been reported.
🚑If you take too much▾

Studies using high doses of the oral suspension did not produce serious unexpected side effects, but overdose reports have included diarrhea, nausea, abdominal pain, shortness of breath, cough, unsteady walking, listlessness, and chest pain. There is no specific antidote. If you suspect an overdose, contact a poison control center right away at 1-800-222-1222 or seek emergency medical care — do not wait for symptoms to worsen.

📡Pharmacodynamics — effects in the body▾

In clinical trials of the oral suspension in AIDS patients with cachexia, megestrol acetate produced meaningful increases in body weight — including non-water body weight — and improved appetite compared to placebo. A greater percentage of patients treated with megestrol acetate reported improvements in appetite, caloric intake, and overall sense of well-being. In women, its progestin activity can cause breakthrough vaginal bleeding, and its glucocorticoid-like (cortisol-mimicking) activity with long-term use can suppress the body's natural hormone stress response and contribute to new or worsened diabetes.

🔬Pharmacokinetics — how your body processes it▾

Megestrol acetate is taken by mouth and absorbed through the gastrointestinal tract, with blood levels generally peaking within 3 to 5 hours of a dose. Taking the oral suspension with a high-fat meal increases absorption, though this effect is less pronounced with the 125 mg/mL formulation than with the older 40 mg/mL product; the 125 mg/mL suspension can be taken without regard to meals. The drug's elimination half-life — the time it takes the body to clear half of the drug — ranges from about 20 to 50 hours in healthy people. Megestrol acetate is broken down mainly in the intestines and liver, and most of the drug is eliminated through urine, with a smaller portion leaving the body through stool.

📦How to store it▾

Store the oral suspension between 20° to 25°C (68° to 77°F). Protect from heat.

📄 Written from Megestrol’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 →

18

Supplements & herbs that interact with Megestrol

18 supplements and herbal products have documented interactions with Megestrol 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 · 8
  • Minor · 9
ACTIVATED CHARCOAL Major COFFEE CHARCOAL Moderate EUROPEAN MANDRAKE Moderate GLUCOMANNAN Moderate GUAR GUM Moderate GUM ARABIC Moderate PREGNENOLONE Moderate SLIPPERY ELM Moderate +10 more
Every supplement checked against Megestrol — ranked by severity The full interaction hub: 1 major · 8 moderate · 9 minor · every one linked to its full report. Check Megestrol 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 Megestrol — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is megestrol acetate used for? ▾
It depends on the form you have. The liquid suspension is used specifically to treat serious appetite loss and weight loss in people with AIDS — your doctor would have prescribed it to help you regain appetite and body weight. The tablet form is used differently — it's for palliative treatment of advanced breast or endometrial (uterine) cancer, meaning it helps manage the disease when it has spread or can't be surgically removed. These are two very different uses, so the form you were given was chosen for a specific reason.
Can I take the oral suspension with food? ▾
Yes — the 125 mg/mL suspension can be taken with or without food, so you don't need to worry about timing it around meals. Just make sure to shake the bottle well before each dose. If you have the older 40 mg/mL formulation, check with your pharmacist, as its dosing guidance is separate. And never swap between the two suspension strengths on your own — they aren't interchangeable.
What side effects should I actually watch out for? ▾
Common ones you might notice include nausea, diarrhea, gas, skin rash, feeling weak or tired, and trouble sleeping. These are generally manageable, but let your doctor know if they bother you. The ones to call your doctor about right away are more serious: dizziness, low blood pressure, unexplained weakness, or vomiting — especially if you've been on this medication a long time or recently stopped it — as these can signal a problem with your adrenal glands. Also watch for signs of a blood clot like leg pain or swelling, chest pain, or sudden shortness of breath.
I heard this can affect my hormones — what does that mean exactly? ▾
That's a really good question. Megestrol acetate is a progestin — a synthetic hormone — so it does interact with your body's hormonal systems. With long-term use, it can suppress your adrenal glands, which are responsible for producing hormones your body needs during stress. This is called adrenal insufficiency. It can also raise blood sugar and, in some people, cause a condition called Cushing's syndrome from too much cortisol-like activity. Your doctor will monitor you for these effects, especially if you're on it for a long time.
Is it safe to take if I'm pregnant or trying to get pregnant? ▾
No — megestrol acetate is contraindicated during pregnancy, meaning you must not take it if you are pregnant. It can cause serious harm to a developing baby, including effects seen in animal studies. If you're a woman who could become pregnant, you'll need a negative pregnancy test before starting the oral suspension, and you must use effective birth control throughout your treatment. If you become pregnant while taking this drug, contact your doctor immediately.
Does megestrol interact with any other medications I might be taking? ▾
A couple of interactions are worth knowing about. If you take warfarin — a blood thinner — megestrol can raise your INR, which is a measure of how quickly your blood clots. That means a higher bleeding risk, so your INR will need to be checked more often. If you're on indinavir, an HIV medication, megestrol can lower indinavir's levels in your bloodstream, which could make it less effective at controlling HIV. Make sure your doctor and pharmacist know about all the medications you're taking so they can keep an eye on these interactions.
Is Megestrol available over the counter? ▾
Megestrol 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 Megestrol first available? ▾
Megestrol has been available in the United States since at least 1971, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Megestrol? ▾
Megestrol is supplied by 32 manufacturers listed in the FDA NDC Directory, including Precision Dose Inc., Major Pharmaceuticals, Bryant Ranch Prepack.

💬 Answers drafted from Megestrol’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

📊Megestrol supplement interactions18 checked — ranked by severity 🌿Drug & Supplement CheckerMegestrol vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Megestrol NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Megestrol comes

Megestrol 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.

Oral suspension

By mouth
How this form is used
What it may be used for
  • Megestrol Acetate oral suspension is used to treat anorexia, cachexia, or unexplained significant weight loss in patients with a diagnosis of AIDS
  • Megestrol Acetate oral suspension is not intended to prevent weight loss before it occurs — it is used after treatable causes of weight loss have been looked for and addressed
Important instructions
  • Megestrol Acetate oral suspension is taken by mouth once daily
  • Shake the Megestrol Acetate oral suspension container well before each use
  • Megestrol Acetate oral suspension (125 mg/mL strength) can be taken with or without food
  • Megestrol Acetate oral suspension 125 mg/mL is not interchangeable with the 40 mg/mL strength — do not substitute one for the other without guidance from your prescriber
Available strengths 3 strengths
40 mg/mL 125 mg/mL 400 mg/10 mL
41 FDA-listed product records ⓘ

Tablet

By mouth
How this form is used
What it may be used for
  • Megestrol Acetate tablets are used for palliative treatment of advanced breast cancer that is recurrent, inoperable, or has spread
  • Megestrol Acetate tablets are used for palliative treatment of advanced endometrial (uterine lining) cancer that is recurrent, inoperable, or has spread
  • Megestrol Acetate tablets are not a substitute for surgery, radiation, or chemotherapy
Important instructions
  • Megestrol Acetate tablets are taken by mouth in divided doses throughout the day
  • At least 2 months of continuous treatment with Megestrol Acetate tablets is considered necessary to properly evaluate whether the medication is working
  • Follow your prescriber's instructions carefully for the number of doses per day — the tablet regimen differs depending on whether it is being used for breast or endometrial cancer
Available strengths 2 strengths
20 mg 40 mg
20 FDA-listed product records ⓘ

📊 Megestrol across the U.S. market

How Megestrol 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 ⓘ
32
Manufacturers
1
Brand names
67
FDA-listed product records ⓘ
1971
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 (6) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Precision Dose Inc.9%
Major Pharmaceuticals9%
Bryant Ranch Prepack9%
Strides Pharma Science Limited7%
Atlantic Biologicals Corp.6%
Par Pharmaceutical, Inc.6%
Other makers54%

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

📈 How widely Megestrol is used

A general measure of how commonly Megestrol 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 Megestrol 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.

91,036
Medicaid prescriptions filled (Q1–Q4 2025)
$3.5M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Megestrol prescribed? Of the 1,596 medications we measure, Megestrol ranks #526 by Medicaid prescriptions — more than 67% of them.

Where Megestrol ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #526 of 1,596
#521 Amphetamine 93,374 Rx #522 Ulipristal 93,222 Rx #523 Imiquimod Topical 92,281 Rx #524 Nebivolol 91,607 Rx #525 Orphenadrine 91,158 Rx #526 Megestrol 91,036 Rx #527 Pimecrolimus Topical 90,935 Rx #528 Acamprosate 89,900 Rx #529 Bupivacaine / Epinephr... 89,693 Rx #530 Glyburide 89,361 Rx #531 Fluticasone / Vilanter... 85,370 Rx

Utilization by Megestrol product

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

The 40 mg/mL oral suspension is the most-dispensed Megestrol product — about 50% of these Medicaid prescriptions.

megestrol acetate 40 MG/ML Oral Suspension Most dispensed

45,763 Medicaid prescriptions (Q1–Q4 2025) 50% of Megestrol prescriptions shown $2.2M gross reimbursement (before rebates) ≈ $49 per prescription (gross)

Summed across the 5 of 77 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 860225

megestrol acetate 40 MG Oral Tablet

29,155 Medicaid prescriptions (Q1–Q4 2025) 32% of Megestrol prescriptions shown $567,952 gross reimbursement (before rebates) ≈ $19 per prescription (gross)

Summed across the 5 of 22 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 860221

megestrol acetate 20 MG Oral Tablet

14,157 Medicaid prescriptions (Q1–Q4 2025) 16% of Megestrol prescriptions shown $233,229 gross reimbursement (before rebates) ≈ $16 per prescription (gross)

Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 860215

megestrol acetate 125 MG/ML Oral Suspension

1,961 Medicaid prescriptions (Q1–Q4 2025) 2% of Megestrol prescriptions shown $459,881 gross reimbursement (before rebates) ≈ $235 per prescription (gross)

Summed across the 1 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 577154

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 Megestrol, 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 13 of 114 listed Megestrol NDCs with Medicaid activity.

🔍 Compare Megestrol products

A representative set of FDA-listed product records for Megestrol — 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 67 of 67 products — FDA National Drug Code Directory. See every product, package size and price: browse all 67 Megestrol 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) Megestrol RxCUI 6703 2 dose forms · 5 strengths
  1. Dose form (SCDF) Oral Suspension RxCUI 372747 In current FDA listings
    Clinical drug / strength (SCD) acetate 125 MG/ML RxCUI 577154 acetate 40 MG/ML RxCUI 860225
  2. Dose form (SCDF) Oral Tablet RxCUI 372748 In current FDA listings
    Clinical drug / strength (SCD) acetate 160 MG RxCUI 860231 acetate 20 MG RxCUI 860215 acetate 40 MG RxCUI 860221

Look up RxCUI 6703 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

Megace ES Megace

🏭 Manufacturers & labelers

Precision Dose Inc. 6 Major Pharmaceuticals 6 Bryant Ranch Prepack 6 Strides Pharma Science Limited 5 Atlantic Biologicals Corp. 4 Par Pharmaceutical, Inc. 4 Teva Pharmaceuticals USA, Inc. 4 Golden State Medical Supply, Inc. 3 McKesson Corporation DBA SKY Packaging 2 Pharmaceutical Associates, Inc. 2 PAI Holdings, LLC dba PAI Pharma 2 Natco Pharma USA LLC 2 TWi Pharmaceuticals, Inc. 2 VistaPharm, Inc. 1 Sicor de Mexico S.A. de C.V 1 Xttrium Laboratories, Inc. 1 Zhejiang Xianju Pharmaceutical Co., Ltd. 1 Upsher-Smith Laboratories, LLC 1 Proficient Rx LP 1 Professional Group Of Pharmacists New York Llc 1 Akorn 1 Preferred Pharmaceuticals Inc. 1 Pinnacle Pharma Llc 1 Pharmacia and Upjohn Company LLC 1

…and 8 more on the FDA NDC directory.

RxNorm drug class

Megestrol belongs to the Progestin class.

Pharmacologic class Progestin
Drug family (ATC) Progestogens, Pregnadien derivatives, Progestogens

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 Nov 30, 2022
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Megestrol.
📈
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 Megestrol after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
21
NDC products indexed
67
Distinct labelers/manufacturers represented
32
Linked representative label ⓘ
Teva Pharmaceuticals USA, Inc.
Linked label effective
Nov 30, 2022
Composite sections available
23
Linked SPL Set ID
66573d39-f2a7-49fd-9ed2-97ac8f6e8456
Linked SPL Document ID
6f22887e-a442-4505-bd99-00042e4075c7
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 21 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. Teva Pharmaceuticals USA, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

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