FDA-filed SPL labeling · retrieved through openFDA

Metoclopramide

Metoclopramide is a prescription tablet that helps move food through the stomach faster, used to treat acid reflux and diabetic gastroparesis in adults.

Brand names Metozolv ODTReglanClopraMaxolonPileran +2 more
Drug classes Dopamine D2 Antagonists
Rx Forms 5 Routes Oral · Intramuscular; Intravenous · Intramuscular, Intravenous · Intravenous +1
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 47 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 effectiveMay 18, 2026
Clinical labels in scope 47
AvailabilityRx
Earliest approval/marketing year 1979
FDA-listed product records 183
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 18, 2026 🚨Recall on record
Other forms & routes:
Metoclopramide at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Metoclopramide can be an effective short-term solution for acid reflux or a sluggish diabetic stomach, but it carries a serious risk of permanent movement problems (tardive dyskinesia) if used too long. Always use the lowest effective dose for the shortest time your doctor recommends, and report any unusual muscle movements right away. Make sure your entire care team knows every medication you take, because several common drugs interact with it.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

Important black-box warning: Metoclopramide can cause tardive dyskinesia (TD) — uncontrolled, potentially permanent muscle movements. TD most often involves the face and tongue, and can sometimes spread to the arms, legs, or trunk. The risk goes up the longer you take the medication and the higher your total lifetime dose. Older adults, especially older women, and people with diabetes are at higher risk. To reduce this risk, metoclopramide should be used for the shortest time possible — and generally no longer than 12 weeks. If you notice any unusual or repetitive movements, stop taking the medication and contact your doctor immediately. People who have had TD or a dystonic (muscle-spasm) reaction to metoclopramide before must not take this drug again.

Read the full warning on DailyMed →

📖 Metoclopramide: Patient Information Guide

A plain-language walkthrough of Metoclopramide — 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

Metoclopramide tablets are prescribed in adults for two main digestive conditions:

  • Gastroesophageal reflux (GERD): When standard treatments haven't helped and stomach acid is still backing up into the esophagus — used for 4 to 12 weeks
  • Diabetic gastroparesis: When diabetes-related nerve damage causes the stomach to empty too slowly, leading to nausea, bloating, or vomiting — used for 2 to 8 weeks
⚙️How it works

Metoclopramide is a prokinetic — it speeds up movement in the upper digestive system without increasing acid or digestive juice production. It works by making stomach muscles contract more powerfully, relaxing the valve between the stomach and small intestine so food can pass through, and tightening the valve at the lower esophagus to reduce acid reflux. It appears to work by sensitizing gut tissue to acetylcholine, a natural signaling chemical, and does not depend on the vagus nerve to do its job.

Importantly, it has little effect on the colon or gallbladder — its action is focused on the stomach and upper small intestine.

💊How it's taken

Metoclopramide is taken as an oral tablet, typically about 30 minutes before meals and at bedtime so it's active during digestion. For intermittent symptoms, a single dose before a triggering situation may be used instead of a daily schedule. Your prescriber will tailor the timing and duration based on your condition.

  • Treatment duration for acid reflux: up to 12 weeks
  • Treatment duration for diabetic gastroparesis: typically 2 to 8 weeks
  • Never use it longer than directed — extended use significantly raises the risk of serious movement side effects
  • If you have kidney disease, liver disease, or take certain other medications, your dose will likely be adjusted
🤒Side effects — in detail

The most common side effects occur in roughly 1 in 10 people and include:

  • Restlessness or agitation
  • Drowsiness and fatigue
  • Headache or dizziness
  • Insomnia
  • Nausea or diarrhea
  • Confusion

More serious reactions — like uncontrolled muscle movements (tardive dyskinesia), painful muscle spasms (acute dystonia), intense inner restlessness (akathisia), high fever with muscle rigidity (neuroleptic malignant syndrome), or depression with suicidal thoughts — require you to stop the medication and seek medical care immediately. Some nervous system side effects (like dizziness or headaches) can also occur after stopping metoclopramide.

⚠️Warnings & precautions

Tardive dyskinesia (TD) is the most critical warning. This is a potentially permanent movement disorder causing repetitive, uncontrolled movements — usually of the face or tongue. Risk increases with longer use and higher total doses, and there is no reliable treatment once it develops. Older adults (especially older women) and people with diabetes are most vulnerable. Stop the medication and call your doctor immediately if you notice any unusual movements.

  • Neuroleptic malignant syndrome (NMS): A rare but life-threatening reaction — high fever, severe muscle stiffness, confusion — seek emergency care
  • Acute dystonic reactions: Sudden, involuntary muscle spasms — treatable but need prompt medical attention
  • Depression and suicidal ideation: Has been reported; avoid use in those with a history of depression
  • High prolactin levels: Can cause breast milk production, missed periods, breast enlargement, or sexual dysfunction
  • Fluid retention: Can worsen heart failure
  • Seizure risk: Can increase seizure frequency — contraindicated in epilepsy
🔀What it interacts with

Metoclopramide interacts with several common medications and substances — always tell your prescriber and pharmacist everything you take:

  • Antipsychotics — combined use raises the risk of serious movement disorders (TD, EPS, NMS); avoid together
  • MAO inhibitors (certain antidepressants) — can cause dangerous spikes in blood pressure; do not combine
  • Alcohol, sedatives, opioids, sleep aids, anti-anxiety medications — add to drowsiness and mental slowing; avoid or use with great caution
  • Strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, paroxetine) — increase metoclopramide blood levels, raising side effect risk; dose may need reducing
  • Anticholinergic drugs and anti-diarrheal medications — can reduce metoclopramide's effectiveness
  • Dopamine agonists (Parkinson's medications, levodopa) — can block metoclopramide's action and vice versa; avoid combining

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
  • History of tardive dyskinesia or a prior dystonic reaction to metoclopramide — do NOT take this drug; it is contraindicated
  • Epilepsy or seizure disorder — contraindicated; metoclopramide can worsen seizures
  • Pheochromocytoma or catecholamine-releasing paraganglioma (adrenal or nerve-tissue tumors) — contraindicated; can trigger a dangerous blood pressure crisis
  • GI bleeding, blockage, or perforation — contraindicated; speeding gut movement could cause serious harm
  • Allergy to metoclopramide — do not take; severe reactions including throat swelling and breathing problems have occurred
  • Parkinson's disease — avoid use
  • Kidney impairment — drug levels build up significantly; dose adjustment required
  • Liver impairment — dose adjustment may be needed
  • Older adults, especially older women — at higher risk of TD; dose should be reduced
  • Pregnancy — metoclopramide crosses the placenta and can cause movement problems or methemoglobinemia (low oxygen-carrying capacity in blood) in newborns; discuss risks with your doctor
  • Breastfeeding — metoclopramide passes into breast milk; nursing infants may experience digestive side effects; discuss with your prescriber
  • Children — not recommended due to risk of TD and methemoglobinemia in newborns
🚑If you take too much

Taking too much metoclopramide can cause drowsiness, disorientation, uncontrolled muscle movements (extrapyramidal reactions), and in serious cases, death. Neuroleptic malignant syndrome — a life-threatening reaction with high fever and muscle rigidity — has also been reported with overdose. There is no specific antidote, so if you suspect an overdose, call Poison Control at 1-800-222-1222 right away.

📡Pharmacodynamics — effects in the body

In people with acid reflux, metoclopramide increases the pressure at the lower esophageal sphincter (the valve between the esophagus and stomach), which helps keep acid from backing up. It also speeds up how fast the stomach empties its contents into the small intestine. These effects are dose-related, meaning a higher dose generally produces a stronger and longer-lasting response — though the drug's use is still tightly time-limited due to safety concerns.

🔬Pharmacokinetics — how your body processes it

Taken by mouth, metoclopramide is well absorbed — about 80% of the dose reaches the bloodstream — with peak blood levels occurring roughly 1 to 2 hours after a dose. The drug is widely distributed throughout the body and is not heavily bound to proteins in the blood. It is broken down primarily in the liver, partly through an enzyme called CYP2D6 (which varies in activity from person to person), and most of it leaves the body through the urine within 72 hours. In people with normal kidney function, the half-life (the time it takes for the body to clear half the drug) is about 5 to 6 hours — but this can be significantly longer in people with kidney disease, making dose adjustment essential.

📦How to store it

Store at 20° to 25°C (68° to 77°F) . PROTECT FROM LIGHT. Dispense in a tight, light-resistant container.

📄 Written from Metoclopramide’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 →

111

Supplements & herbs that interact with Metoclopramide

111 supplements and herbal products have documented interactions with Metoclopramide 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 · 8
  • Moderate · 88
  • Minor · 15
Every supplement checked against Metoclopramide — ranked by severity The full interaction hub: 8 major · 88 moderate · 15 minor · every one linked to its full report. Check Metoclopramide 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 Metoclopramide — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is metoclopramide supposed to do for me?
It helps your digestive system move food along faster. If you have acid reflux, it tightens the valve between your esophagus and stomach so acid is less likely to back up. If you have diabetic gastroparesis — where your stomach empties too slowly because of nerve damage — it helps your stomach contract more effectively to push food through. Think of it as giving your gut a bit of extra horsepower where it needs it.
How long will I need to take it?
This medication is meant to be short-term. For acid reflux, treatment is generally 4 to 12 weeks. For diabetic gastroparesis, it's usually 2 to 8 weeks. Using it longer than recommended significantly raises your risk of a serious and potentially permanent movement disorder called tardive dyskinesia, so your prescriber should reassess regularly whether you still need it.
What side effects should I watch out for — and which ones mean I need to call someone right away?
The most common ones — restlessness, drowsiness, and fatigue — affect roughly 1 in 10 people and are usually manageable. The ones that need urgent attention are any unusual or repetitive movements of your face, tongue, arms, or legs (that's a warning sign of tardive dyskinesia), sudden painful muscle spasms, high fever with muscle stiffness, or feelings of depression or thoughts of self-harm. If any of those happen, stop the medication and get medical help right away — don't wait for your next appointment.
Are there medications I need to be careful about combining with this?
Yes, quite a few. Antipsychotic medications, MAO inhibitor antidepressants, and certain antidepressants like fluoxetine (Prozac) or paroxetine (Paxil) can all cause problems when combined with metoclopramide — ranging from dangerously high blood pressure to increased risk of movement disorders. Alcohol, sleep aids, opioids, and anti-anxiety medications increase drowsiness significantly. Make sure your prescriber and pharmacist have a full list of everything you take, including over-the-counter products.
Is it safe to take if I'm pregnant or breastfeeding?
If you're pregnant, it's important to talk to your doctor before taking this. Metoclopramide does cross the placenta, and when used close to delivery, it can cause movement problems or a blood oxygen issue in the newborn. If you're breastfeeding, the drug does pass into breast milk, and some nursing infants have had stomach upset. The decision to use it while breastfeeding should be made together with your healthcare provider, weighing the benefits to you against the potential effects on your baby.
I have kidney problems — does that affect how I take this?
It does, yes. When your kidneys aren't working at full capacity, metoclopramide can build up to much higher levels in your body than normal — and that increases your risk of side effects. Your prescriber should reduce the dose to account for that. Make sure they know your kidney function status before you start, and remind any new provider who prescribes for you as well.
Is Metoclopramide available over the counter?
Metoclopramide 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 Metoclopramide first available?
Metoclopramide has been available in the United States since at least 1979, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Metoclopramide?
Metoclopramide is supplied by 60 manufacturers listed in the FDA NDC Directory, including Bryant Ranch Prepack, ANI Pharmaceuticals, Inc., Remedyrepack Inc..

💬 Answers drafted from Metoclopramide’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

💊 How Metoclopramide comes

Metoclopramide is available in 5 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 Reglan
Available strengths 2 strengths
97 FDA-listed product records

Injection

Into a muscle · Into a vein
Available strengths 2 strengths
42 FDA-listed product records

Oral solution

By mouth
Available strengths 1 strength
30 FDA-listed product records

Nasal spray

In the nose
Brands Gimoti
Available strengths 1 strength
2 FDA-listed product records

Orally disintegrating tablet

By mouth
Available strengths 2 strengths
2 FDA-listed product records

📊 Metoclopramide across the U.S. market

How Metoclopramide 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.

5
Dose forms
60
Manufacturers
4
Brand names
183
FDA-listed product records
1979
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 (8) · Crystal (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack11%
ANI Pharmaceuticals, Inc.6%
Remedyrepack Inc.6%
Cardinal Health 107, LLC5%
American Health Packaging4%
NuCare Pharmaceuticals, Inc.4%
Other makers64%

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

📈 How widely Metoclopramide is used

A general measure of how commonly Metoclopramide 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 Metoclopramide 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.

712,920
Medicaid prescriptions filled (Q1–Q4 2025)
$11M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Metoclopramide prescribed? Of the 1,596 medications we measure, Metoclopramide ranks #218 by Medicaid prescriptions — more than 86% of them.

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

Utilization by Metoclopramide 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 tablet is the most-dispensed Metoclopramide product — about 58% of these Medicaid prescriptions.

metoclopramide 10 MG Oral Tablet Most dispensed

413,086 Medicaid prescriptions (Q1–Q4 2025) 58% of Metoclopramide prescriptions shown $3.6M gross reimbursement (before rebates) ≈ $8.78 per prescription (gross)

Summed across the 12 of 67 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311666

metoclopramide 5 MG Oral Tablet

203,165 Medicaid prescriptions (Q1–Q4 2025) 28% of Metoclopramide prescriptions shown $1.8M gross reimbursement (before rebates) ≈ $8.80 per prescription (gross)

Summed across the 8 of 40 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311668

2 ML metoclopramide 5 MG/ML Injection

67,770 Medicaid prescriptions (Q1–Q4 2025) 10% of Metoclopramide prescriptions shown $2.7M gross reimbursement (before rebates) ≈ $40 per prescription (gross)

Summed across the 7 of 31 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311670

metoclopramide 1 MG/ML Oral Solution

27,880 Medicaid prescriptions (Q1–Q4 2025) 4% of Metoclopramide prescriptions shown $804,313 gross reimbursement (before rebates) ≈ $29 per prescription (gross)

Summed across the 5 of 28 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 104884

metoclopramide 15 MG/ACTUAT Nasal Spray

893 Medicaid prescriptions (Q1–Q4 2025) <1% of Metoclopramide prescriptions shown $2M gross reimbursement (before rebates) ≈ $2,294 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2380564

2 ML metoclopramide 5 MG/ML Prefilled Syringe

126 Medicaid prescriptions (Q1–Q4 2025) <1% of Metoclopramide prescriptions shown $45 gross reimbursement (before rebates) ≈ $0.36 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 727619

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 Metoclopramide, 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 34 of 172 listed Metoclopramide NDCs with Medicaid activity.

🔍 Compare Metoclopramide products

A representative set of FDA-listed product records for Metoclopramide — 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 183 of 183 products — FDA National Drug Code Directory. See every product, package size and price: browse all 183 Metoclopramide 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) Metoclopramide RxCUI 6915 8 dose forms · 10 strengths
  1. Dose form (SCDF) Disintegrating Oral Tablet RxCUI 608622 In current FDA listings
    Clinical drug / strength (SCD) 5 MG RxCUI 608624 10 MG RxCUI 608623
  2. Dose form (SCDF) Extended Release Oral Capsule RxCUI 372882 No current FDA listing
  3. Dose form (SCDF) Extended Release Oral Tablet RxCUI 372887 No current FDA listing
    Clinical drug / strength (SCD) 15 MG RxCUI 250712
  4. Dose form (SCDF) Injection RxCUI 1740916 In current FDA listings
    Clinical drug / strength (SCD) 2 ML metoclopramide 5 MG/ML RxCUI 311670
  5. Dose form (SCDF) Nasal Spray RxCUI 2380563 In current FDA listings
    Clinical drug / strength (SCD) 15 MG/ACTUAT RxCUI 2380564
  6. Dose form (SCDF) Oral Solution RxCUI 372883 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 5 MG/ML RxCUI 1431136 1 MG/ML RxCUI 104884
  7. Dose form (SCDF) Oral Tablet RxCUI 372886 In current FDA listings
    Clinical drug / strength (SCD) 5 MG RxCUI 311668 10 MG RxCUI 311666
  8. Dose form (SCDF) Prefilled Syringe RxCUI 727618 No current FDA listing
    Clinical drug / strength (SCD) 2 ML metoclopramide 5 MG/ML RxCUI 727619

Look up RxCUI 6915 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

Metozolv ODT Reglan Clopra Maxolon Pileran Gimoti Metozolv

🏭 Manufacturers & labelers

Bryant Ranch Prepack 18 ANI Pharmaceuticals, Inc. 10 Remedyrepack Inc. 9 Cardinal Health 107, LLC 8 American Health Packaging 7 NuCare Pharmaceuticals, Inc. 7 Hospira, Inc. 6 HF Acquisition Co LLC, DBA HealthFirst 6 Ipca Laboratories Limited 6 NuCare Pharmaceuticals,Inc. 6 NCS HealthCare of KY, LLC dba Vangard Labs 6 Preferred Pharmaceuticals Inc. 5 Medical Purchasing Solutions, LLC 5 Proficient Rx LP 4 Mylan Institutional Inc. 4 Teva Pharmaceuticals USA, Inc. 4 Teva Parenteral Medicines, Inc. 4 Fresenius Kabi USA, LLC 4 A-S Medication Solutions 3 Cardinal Health 3 Henry Schein, Inc. 3 Atlantic Biologicals Corp. 3 AvKARE 3 Redpharm Drug 2

…and 16 more on the FDA NDC directory.

RxNorm drug class

Metoclopramide belongs to the Dopamine-2 Receptor Antagonist class.

Pharmacologic class Dopamine-2 Receptor Antagonist
Drug family (ATC) Propulsives
How it works Dopamine D2 Antagonists

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 May 18, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Metoclopramide.
📈
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 Metoclopramide after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
47
NDC products indexed
183
Distinct labelers/manufacturers represented
60
Linked representative label
ANI Pharmaceuticals, Inc.
Linked label effective
May 18, 2026
Composite sections available
22
Linked SPL Set ID
797aad80-0597-42f8-99d5-39de180c3b5a
Linked SPL Document ID
6d4ed2af-6756-4e7a-8325-820490408f5f
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 47 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. ANI 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.