Valacyclovir

Valacyclovir is an antiviral medicine used to treat and prevent outbreaks of herpes infections, including cold sores, genital herpes, shingles and (in children) chickenpox.

Brand name Valtrex
Drug classes ⓘ Dna Polymerase Inhibitors
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Built from the FDA-approved label, dated Feb 16, 2026 Last reviewed Jul 10, 2026 Content updated Oct 1, 2026 How this page is built
✓No current FDA shortage listed · checked Oct 1, 2026
⭐ Valacyclovir at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The pharmacist’s bottom lineWritten from the FDA label in plain language · reviewed by
Valacyclovir is a well-established antiviral for cold sores, genital herpes, shingles and, in children, chickenpox. Most people have only mild side effects such as headache or nausea. Stay hydrated, take it exactly as prescribed, and get help quickly for a severe rash, confusion, or changes in urination.
How we write & review this content — our editorial policy →
AvailabilityRx
Dose formsTablet
First marketed1995
Makers70
Linked label effectiveFeb 16, 2026
Boxed warningNone found

⚡ Quick answers about Valacyclovir

What is valacyclovir for?

It treats herpes virus infections. That includes cold sores, genital herpes, and shingles in adults. Children can use it for cold sores (age 12 and older) and chickenpox (ages 2 to under 18).

Read the full answer →

Do I need to take it with food?

No, you can take it with or without food. Do try to drink plenty of fluids while you are on it, since good hydration helps protect your kidneys.

See it in the FAQ →

When should I start it?

As early as you can. For cold sores, start at the first tingling, itching or burning. Treatment works best for genital herpes and shingles when started within a day or two of symptoms starting.

See it in the FAQ →

What side effects should I expect?

The most common ones are headache, nausea and stomach pain. Some people also get vomiting or dizziness. These are usually mild, but tell me if they bother you.

See it in the FAQ →
🧬 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 107 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 →

How we combine label and product data →

📖 Valacyclovir: Patient Information Guide

A plain-language walkthrough of Valacyclovir — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

What Valacyclovir is used for

▾

Valacyclovir is used for several herpes virus infections.

  • Cold sores (herpes labialis) in adults, and in children 12 and older
  • Genital herpes in adults: first episode, repeat episodes, long-term suppression (including in people with HIV-1), and reducing transmission
  • Shingles (herpes zoster) in adults with normal immune function
  • Chickenpox in children ages 2 to under 18 with normal immune function

How Valacyclovir works

▾

After you swallow it, valacyclovir is quickly turned into acyclovir. Acyclovir is activated inside virus-infected cells by a viral enzyme. It then interferes with the virus's DNA copying in three ways: it competes with the virus's building blocks, it stops the growing DNA chain, and it disables the viral copying enzyme.

It works better against herpes simplex virus than against the chickenpox and shingles virus, because the herpes simplex virus activates it more efficiently.

How Valacyclovir is taken (dosage)

▾

Valacyclovir tablets are taken by mouth and can be taken with or without food. Length of treatment varies a lot: a single day for cold sores, a week or so for shingles, or daily long-term use for suppression. Treatment works best when started early, such as at the first tingle of a cold sore or within a day or two of genital herpes or shingles symptoms.

  • Follow your prescriber and the label exactly.
  • Drink plenty of fluids.
  • For children who cannot swallow tablets, a liquid can be prepared from the 500 mg tablets.

Dosing details from the FDA-approved label

Excerpt from the Valacyclovir 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.

2 DOSAGE AND ADMINISTRATION • Valacyclovir tablets may be given without regard to meals. • Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from 500-mg valacyclovir tablets for use in pediatric patients for whom a solid dosage form is not appropriate [see Dosage and Administration (2.3) ] . Adult Dosage ( 2.1 ) Cold Sores 2 grams every 12 hours for 1 day Genital Herpes Initial episode 1 gram twice daily for 10 days Recurrent episodes 500 mg twice daily for 3 days Suppressive therapy Immunocompetent patients 1 gram once daily Alternate dose in patients with less than or equal to 9 recurrences/year 500 mg once daily HIV-1–infected patients 500 mg twice daily Reduction of transmission 500 mg once daily Herpes Zoster 1 gram 3 times daily for 7 days Pediatric Dosage ( 2.2 ) Cold Sores (aged greater than or equal to 12 years) 2 grams every 12 hours for 1 day Chickenpox (aged 2 to less than 18 years) 20 mg/kg 3 times daily for 5 days; not to exceed 1 gram 3 times daily Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) can be prepared from the 500 mg valacyclovir tablets. ( 2.3 ) 2.1 Adult Dosing Recommendations Cold Sores (Herpes Labialis) The recommended dosage of valacyclovir tablets for treatment of cold sores is 2 grams twice daily for 1 day taken 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g., tingling, itching, or burning). Genital Herpes Initial Episode The recommended dosage of valacyclovir tablets for treatment of initial genital herpes is 1 gram twice daily for 10 days. Therapy was most effective when administered within 48 hours of the onset of signs and symptoms. Recurrent Episodes The recommended dosage of valacyclovir tablets for treatment of recurrent genital herpes is 500 mg twice daily for 3 days. Initiate treatment at the first sign or symptom of an episode. Suppressive Therapy The recommended dosage of valacyclovir tablets for chronic suppressive therapy of recurrent genital herpes is 1 gram once daily in patients with normal immune function. In patients with a history of 9 or fewer recurrences per year, an alternative dose is 500 mg once daily. In HIV-1–infected patients with a CD4+ cell count greater than or equal to 100 cells/mm 3 , the recommended dosage of valacyclovir tablets for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Valacyclovir side effects in detail

▾

Common side effects

  • Headache
  • Nausea
  • Stomach pain
  • Vomiting
  • Dizziness
  • Tiredness (more often in people with HIV-1)
  • Rash (more often in people with HIV-1)

When to get medical help

  • Get medical help right away for a painful rash with sores in the mouth, eyes or other moist areas, or a severe rash that keeps spreading. Stop the medicine and call right away.
  • Call your doctor for confusion, hallucinations, agitation, seizures or unusual behavior.
  • Call your doctor if you notice a big drop in urination, kidney pain or swelling, which may signal kidney failure.
  • Seek help for signs of a serious allergic reaction, such as swelling of the face, trouble breathing or hives.
  • Tell your doctor right away about unexplained bruising, bleeding, or severe tiredness, especially if you have advanced HIV-1 or a transplant. These can be signs of a rare blood and kidney problem (TTP/HUS).

Most people tolerate valacyclovir well. Common side effects include:

  • Headache
  • Nausea
  • Stomach pain
  • Vomiting
  • Dizziness

Serious reactions are less common but need quick action. They include severe skin rashes, confusion or hallucinations, kidney failure and allergic reactions.

Valacyclovir warnings and precautions

▾
  • Kidney failure: More likely in older adults, people with kidney disease, those on other kidney-stressing drugs, and those who are dehydrated.
  • Nervous system effects: Agitation, hallucinations, confusion, seizures. Older adults are more prone. Stop the medicine if these occur.
  • Severe skin reactions: Stop right away for a painful rash with mouth or mucous membrane sores, or a severe, spreading rash.
  • TTP/HUS: A rare blood and kidney condition, seen at very high doses in people with advanced HIV-1 or transplants.

Valacyclovir interactions: what it interacts with

▾

No clinically significant drug-drug or drug-food interactions are known for valacyclovir tablets.

  • Other kidney-harming (nephrotoxic) drugs: use caution because of added kidney risk.

Interactions listed in the FDA-approved label

Excerpt from the Valacyclovir prescribing information (“Drug Interactions”). This is what the manufacturer studied or reported to the FDA.

7 DRUG INTERACTIONS No clinically significant drug-drug or drug-food interactions with valacyclovir tablets are known [see Clinical Pharmacology (12.3) ].

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.

🌿27 supplements and herbs with documented Valacyclovir interactions, ranked by severity Check Valacyclovir against a supplement or herb →

Before taking Valacyclovir

▾
  • Do not use if you have had a serious allergic reaction to valacyclovir or acyclovir.
  • Tell your prescriber about kidney disease, since the dose may need lowering.
  • Older adults need extra caution.
  • Pregnancy: long-term data have not shown a higher risk of major birth defects, though other outcome data are limited.
  • Breastfeeding: acyclovir passes into breast milk. Discuss the risks and benefits with your doctor.
  • Effectiveness is not established in people with weakened immune systems, other than genital herpes suppression in HIV-1.

Valacyclovir overdose: if you take too much

▾

Too much valacyclovir can cause acyclovir to build up in the kidneys and lead to acute kidney failure. Take care to avoid accidental overdose. If kidney failure with very little urine occurs, hemodialysis may help restore kidney function, so seek medical help right away.

Pharmacodynamics: what Valacyclovir does in the body

▾

Valacyclovir's active form, acyclovir, shuts down herpes virus DNA copying. It is active against herpes simplex virus types 1 and 2 and varicella-zoster virus, and works better against herpes simplex virus than against the chickenpox and shingles virus.

Pharmacokinetics: how your body processes Valacyclovir

▾

Valacyclovir is absorbed quickly from the gut and almost completely converted to acyclovir. About 54.5% of acyclovir becomes available to the body, and food does not change this. Acyclovir has a half-life of about 2.5 to 3.3 hours in people with normal kidney function. It is cleared mostly through the kidneys, which is why people with kidney problems may need lower doses.

How to store Valacyclovir

▾

Store at 20º to 25ºC (68º to 77ºF). Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

📄 Written from Valacyclovir’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 →

27

Supplements & herbs that interact with Valacyclovir

27 supplements and herbal products have documented interactions with Valacyclovir 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 · 17
  • Minor · 9
ACTIVATED CHARCOAL Major AFRICAN WILD POTATO Moderate Banderol Moderate BIOFEEDBACK Moderate CAFFEIC ACID Moderate COFFEE CHARCOAL Moderate DENDROBIUM Moderate EUROPEAN MANDRAKE Moderate +19 more
Every supplement checked against Valacyclovir — ranked by severity The full interaction hub: 1 major · 17 moderate · 9 minor · every one linked to its full report. Check Valacyclovir 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.

🩺 Valacyclovir: pharmacist answers to common questions

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

What is valacyclovir for?

▾
It treats herpes virus infections. That includes cold sores, genital herpes, and shingles in adults. Children can use it for cold sores (age 12 and older) and chickenpox (ages 2 to under 18). Some people also take it daily to prevent repeat genital herpes outbreaks or to lower the chance of passing it on.

Do I need to take it with food?

▾
No, you can take it with or without food. Do try to drink plenty of fluids while you are on it, since good hydration helps protect your kidneys.

When should I start it?

▾
As early as you can. For cold sores, start at the first tingling, itching or burning. Treatment works best for genital herpes and shingles when started within a day or two of symptoms starting.

What side effects should I expect?

▾
The most common ones are headache, nausea and stomach pain. Some people also get vomiting or dizziness. These are usually mild, but tell me if they bother you.

When should I call my doctor?

▾
Call right away if you get confusion, hallucinations or seizures, a painful rash with sores in your mouth or eyes, a severe spreading rash, signs of an allergic reaction, or a big drop in urination. These can be serious and need quick attention.

Is it safe in pregnancy or while breastfeeding?

▾
Decades of data haven't shown a higher risk of major birth defects, though there isn't enough information on miscarriage or other outcomes. Untreated herpes in pregnancy can also carry risks to the baby. Acyclovir does pass into breast milk, so talk with your doctor about the best plan for you.

Is Valacyclovir available over the counter?

▾
Valacyclovir 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 Valacyclovir first available?

▾
Valacyclovir has been available in the United States since at least 1995, based on FDA approval history (Drugs@FDA) and product marketing records.

Who makes Valacyclovir?

▾
Valacyclovir is supplied by 70 manufacturers listed in the FDA NDC Directory, including Remedyrepack Inc., A-S Medication Solutions, NuCare Pharmaceuticals,Inc..

💬 Answers drafted from Valacyclovir’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 →

🧰 More about Valacyclovir on HelloPharmacist

📊Valacyclovir supplement interactions27 checked — ranked by severity 🌿Drug & Supplement CheckerValacyclovir vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Valacyclovir NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 Valacyclovir forms and strengths (how it comes)

Valacyclovir 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.

Tablet

By mouth
Brands Valtrex
How this form is used
What it may be used for
  • Valtrex tablets treat cold sores, genital herpes and shingles in adults.
  • Valtrex tablets also treat cold sores in children 12 and older and chickenpox in children 2 to under 18.
  • Valacyclovir tablets are also used to reduce the spread of genital herpes and to suppress repeat outbreaks.
Important instructions
  • Valtrex tablets may be taken with or without food.
  • Valtrex 500 mg tablets can be used to prepare a liquid suspension for children who cannot use a solid dosage form.
Available strengths 3 strengths
500 mg 1 g 1000 mg
298 FDA-listed product records ⓘ

📊 Valacyclovir on the U.S. market: products, makers and brands

How Valacyclovir 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.

70 companies list 315 Valacyclovir product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 1995. Brand names on the directory include Valtrex; the rest are generics.

1
Dose forms ⓘ
70
Manufacturers
3
Brand names
315
FDA-listed product records ⓘ
1995
First marketed ⓘ

Also listed with the FDA, not a patient dose form: Powder (17) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Remedyrepack Inc.10%
A-S Medication Solutions8%
NuCare Pharmaceuticals,Inc.8%
Bryant Ranch Prepack7%
PD-Rx Pharmaceuticals, Inc.6%
Preferred Pharmaceuticals Inc.4%
Other makers57%

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

📈 How widely Valacyclovir is used (Medicaid data)

A general measure of how commonly Valacyclovir 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 Valacyclovir 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.

1,885,604
Medicaid prescriptions filled (Q1–Q4 2025)
$33.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Valacyclovir prescribed? Of the 1,599 medications we measure, Valacyclovir ranks #115 by Medicaid prescriptions — more than 93% of them.

Where Valacyclovir ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #115 of 1,599
#110 Dexamethasone 2,033,076 Rx #111 Prazosin 2,024,285 Rx #112 Potassium 1,949,817 Rx #113 Nicotine 1,920,723 Rx #114 Dulaglutide Injection 1,895,289 Rx #115 Valacyclovir 1,885,604 Rx #116 Dexmethylphenidate 1,880,821 Rx #117 Ketorolac 1,877,272 Rx #118 Fluticasone Oral Inhal... 1,858,417 Rx #119 Potassium Chloride 1,842,382 Rx #120 Fluticasone and Salmet... 1,781,081 Rx

Utilization by Valacyclovir 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 1000 mg oral tablet is the most-dispensed Valacyclovir product — about 51% of these Medicaid prescriptions.

valacyclovir 1000 MG Oral Tablet Most dispensed

961,765 Medicaid prescriptions (Q1–Q4 2025) 51% of Valacyclovir prescriptions shown $17.6M gross reimbursement (before rebates) ≈ $18 per prescription (gross)

Summed across the 15 of 276 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313564

valacyclovir 500 MG Oral Tablet

923,839 Medicaid prescriptions (Q1–Q4 2025) 49% of Valacyclovir prescriptions shown $16.3M gross reimbursement (before rebates) ≈ $18 per prescription (gross)

Summed across the 19 of 262 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313565

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 Valacyclovir, 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 538 listed Valacyclovir NDCs with Medicaid activity.

🔍 Compare Valacyclovir products

A representative set of FDA-listed product records for Valacyclovir — 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 315 products — FDA National Drug Code Directory. See every product, package size and price: browse all 315 Valacyclovir 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) Valacyclovir RxCUI 73645 1 dose form · 3 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 374272 In current FDA listings
    Clinical drug / strength (SCD) 250 MG RxCUI 427105 500 MG RxCUI 313565 1000 MG RxCUI 313564

Look up RxCUI 73645 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.

🏷️ Valacyclovir brand names

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

Valtrex

🏭 Who makes Valacyclovir: manufacturers and labelers

40 companies list Valacyclovir products with the FDA. By number of product records, the largest are Remedyrepack Inc., A-S Medication Solutions, NuCare Pharmaceuticals,Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Remedyrepack Inc. 28 A-S Medication Solutions 21 NuCare Pharmaceuticals,Inc. 21 Bryant Ranch Prepack 20 PD-Rx Pharmaceuticals, Inc. 17 Preferred Pharmaceuticals Inc. 11 Proficient Rx LP 10 Golden State Medical Supply, Inc. 8 Aurobindo Pharma Limited 7 Mylan Pharmaceuticals Inc. 6 NuCare Pharmaceuticals, Inc. 6 RPK Pharmaceuticals, Inc. 6 NorthStar Rx LLC 6 Northwind Health Company, LLC 6 RedPharm Drug, Inc. 6 GlaxoSmithKline LLC 6 Yiling Pharmaceutical, Inc. 6 Sun Pharmaceutical Industries, Inc. 6 Direct Rx 5 Denton Pharma, Inc. DBA Northwind Pharmaceuticals 4 American Health Packaging 4 Westminster Pharmaceuticals, LLC 4 AvPAK 4 Camber Pharmaceuticals, Inc. 4

…and 16 more on the FDA NDC directory.

Valacyclovir drug class (RxNorm)

Valacyclovir belongs to the Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor class.

Pharmacologic class Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor, Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor, Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor
Drug family (ATC) Nucleosides and nucleotides excl. reverse transcriptase inhibitors
How it works DNA Polymerase 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.

🔬 Sources for this Valacyclovir 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 Feb 16, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Valacyclovir.
📈
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 Valacyclovir after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
107
NDC products indexed
315
Distinct labelers/manufacturers represented
70
Linked representative label ⓘ
Mylan Pharmaceuticals Inc.
Linked label effective
Feb 16, 2026
Composite sections available
20
Linked SPL Set ID
56bf715d-8280-4557-9f98-9693932199e5
Linked SPL Document ID
7de6158d-06ad-4500-a485-dafc151c16ff
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 107 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Mylan Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

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