FDA-filed SPL labeling · retrieved through openFDA

Phytonadione

Phytonadione (vitamin K1) is a vitamin K replacement used to treat and prevent bleeding problems caused by low levels of clotting factors — including those caused by blood thinners, certain antibiotics, and conditions that block vitamin K absorption.

Brand names MephytonVeta-K1Vitamin K1
Drug classes Vitamin K
Rx Forms 4 Routes Oral · Intramuscular, Intravenous, Subcutaneous · Intramuscular; Intravenous; Subcutaneous · Parenteral
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 effectiveOct 23, 2025
Clinical labels in scope 21
AvailabilityRx
Earliest approval/marketing year 1955
FDA-listed product records 81
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 19, 2026 🚨Recall on record
Phytonadione at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Phytonadione is a form of vitamin K used to correct dangerous clotting problems caused by blood thinners, certain antibiotics, or conditions that prevent vitamin K absorption. The injectable form carries a serious risk of life-threatening allergic reactions with IV or IM use, so subcutaneous injection is always preferred when injections are needed. Always take it exactly as prescribed, and keep all follow-up appointments so your clotting levels can be monitored.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

Fatal allergic reactions have occurred with intravenous (IV) and intramuscular (IM) injection of phytonadione, including on the very first dose. These reactions — which can include anaphylaxis (severe whole-body allergic reaction), shock, and cardiorespiratory arrest — have happened even when the drug was diluted and given slowly. Because of this risk, the IV and IM routes should be avoided unless giving the medication under the skin (subcutaneously) is simply not possible and the benefit clearly outweighs the serious danger. If you or a loved one receives this drug by injection, medical staff should be ready to respond to a severe reaction immediately.

Read the full warning on DailyMed →

📖 Phytonadione: Patient Information Guide

A plain-language walkthrough of Phytonadione — 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

Phytonadione (vitamin K1) is a vitamin K replacement used to correct bleeding disorders when the body cannot produce enough active clotting factors. Supported uses span multiple products and routes:

  • Treats hypoprothrombinemia (dangerously low clotting proteins) caused by coumarin-type or indanedione blood thinners — available as tablets (adults only) and injectable emulsion
  • Treats hypoprothrombinemia caused by antibiotic therapy — available as tablets (adults only) and injectable emulsion
  • Treats hypoprothrombinemia from drugs that interfere with vitamin K metabolism, including high-dose salicylates — available as tablets (adults only) and injectable emulsion
  • Treats hypoprothrombinemia from conditions that block vitamin K absorption or synthesis — including obstructive jaundice, biliary fistula, ulcerative colitis, celiac disease, Crohn's disease (regional enteritis), intestinal resection, cystic fibrosis of the pancreas, and sprue — available as tablets (adults only) and injectable emulsion
  • Vitamin K1 Injection and Phytonadione injectable emulsion are specifically approved for prevention and treatment of vitamin K-deficiency bleeding in newborns (hemorrhagic disease of the newborn) — the oral tablet is not approved for this use
⚙️How it works

Phytonadione acts exactly like the vitamin K your body produces naturally. The liver relies on vitamin K as an essential cofactor — a helper molecule — to convert inactive precursor proteins into four active clotting factors: factor II (prothrombin), factor VII (proconvertin), factor IX, and factor X. When vitamin K is missing or blocked by a drug like warfarin, those clotting factors can't be completed, and the blood loses its ability to clot properly. Phytonadione restores the missing vitamin K activity, allowing the liver to manufacture working clotting factors and reduce bleeding risk.

Importantly, phytonadione has no real pharmacological effect in people who already have adequate vitamin K levels — its action only becomes meaningful when there is a true deficiency or drug-related interference.

💊How it's taken

Phytonadione is available as an oral tablet and as an injectable emulsion. The oral tablet (Mephyton; Phytonadione tablets) is taken by mouth and is approved for adults only; if bile flow is reduced, bile salts must be taken at the same time to help absorption. The injectable emulsion is given under the skin (subcutaneous), into a muscle (intramuscular), or into a vein (intravenous), with subcutaneous being strongly preferred due to serious risks with IV and IM routes.

  • Effects are not immediate — improvement in clotting tests (INR) may take 1 to 8 hours after dosing
  • If bleeding is severe, additional therapies such as blood products may be needed alongside phytonadione
  • Dosage is kept as low as possible and guided by regular INR or prothrombin time monitoring
  • Always follow your prescriber's instructions exactly — do not adjust the dose on your own
🤒Side effects — in detail

The most commonly reported side effects of phytonadione include:

  • Flushing (warmth or redness)
  • Dizziness
  • Altered taste (dysgeusia)
  • Shortness of breath (dyspnea)
  • Rapid heartbeat (tachycardia)
  • Low blood pressure (hypotension)
  • Bluish skin color (cyanosis)
  • Sweating (diaphoresis)
  • Pain, swelling, or tenderness at the injection site

Seek emergency care immediately if you experience any signs of a severe allergic reaction — difficulty breathing, swelling of the face or throat, chest pain, or sudden drop in blood pressure. Skin reactions such as hardened patches or eczema-like sores can appear at the injection site days to months after use and should be reported to your doctor promptly.

⚠️Warnings & precautions
  • Life-threatening allergic reactions (anaphylaxis): Fatal reactions have occurred with IV and IM injection, even on the first dose and even when the drug was diluted and given slowly. The subcutaneous route must be used whenever possible.
  • Benzyl alcohol toxicity in newborns and infants: Some injectable formulations contain benzyl alcohol as a preservative. In premature and newborn babies, this preservative can cause "gasping syndrome" — a dangerous condition involving breathing failure, seizures, and cardiovascular collapse. Always use benzyl alcohol-free formulations in neonates and infants when available.
  • Skin (cutaneous) reactions: Eczema-like patches, hardened scleroderma-like skin changes, hives, and other skin reactions have been reported after injection — sometimes appearing up to a year later. Discontinue the drug and seek medical care if these develop.
  • Aluminum toxicity: Certain injectable formulations contain aluminum. In patients with kidney impairment — especially premature newborns — aluminum can accumulate and cause bone and nervous system toxicity with long-term parenteral use.
  • Blood clotting rebound risk: Using too much phytonadione when reversing anticoagulant therapy can swing the balance too far toward clotting, potentially restoring the clot-forming conditions that originally required anticoagulant treatment. Use the lowest effective dose.
🔀What it interacts with

Phytonadione has a clinically important interaction with anticoagulant medications:

  • Coumarin-type blood thinners (e.g., warfarin) and indanedione anticoagulants: Phytonadione can cause temporary resistance to these drugs, especially at higher doses. When anticoagulant therapy is restarted after phytonadione use, higher doses of the blood thinner — or a switch to a different anticoagulant class such as heparin — may be needed.
  • Heparin: Phytonadione does not affect heparin's anticoagulant action. It will not reverse bleeding caused by heparin.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Allergy to phytonadione: Do not take if you have had a prior hypersensitivity reaction to phytonadione or any inactive ingredient in the product — this is a contraindication.
  • Pregnancy: If injectable phytonadione is needed during pregnancy, a benzyl alcohol-free formulation is recommended to protect the baby. Studies have not shown a clear link between phytonadione use and birth defects, but vitamin K deficiency during pregnancy itself carries risks of bleeding.
  • Breastfeeding: Phytonadione passes into breast milk. Use a preservative-free formulation whenever possible; discuss the benefits and risks with your prescriber.
  • Newborns and premature infants: Use benzyl alcohol-free formulations. Premature and low-birth-weight babies are especially vulnerable to benzyl alcohol toxicity and aluminum accumulation.
  • Children ages 6 months to 17 years: Safety and effectiveness of the injectable emulsion in this age group have not been established.
  • Kidney impairment: Patients with reduced kidney function receiving long-term IV phytonadione should be monitored for aluminum toxicity, as some formulations contain aluminum.
  • Malabsorption conditions: The oral tablet is not suitable if your gut cannot absorb it properly. Bile salts are required alongside the tablet when bile flow is insufficient.
🚑If you take too much

An overdose of phytonadione injectable emulsion in newborns — particularly premature infants — can cause hemolysis (breakdown of red blood cells), jaundice (yellowing of the skin and eyes), and hyperbilirubinemia (high bilirubin levels in the blood). If you suspect an overdose, contact a healthcare provider or poison control center immediately.

📡Pharmacodynamics — effects in the body

When phytonadione is given intravenously, its effect on the blood's ability to clot is usually detectable within one to two hours. Bleeding is generally controlled within three to six hours. A normal INR — the standard measure of clotting time — can often be restored within 12 to 14 hours after an IV dose. The goal of therapy is to restore normal clotting factor activity using the lowest dose necessary.

🔬Pharmacokinetics — how your body processes it

When taken by mouth, phytonadione is adequately absorbed from the gastrointestinal tract only when bile salts are present. After injection, it is readily absorbed and is quickly concentrated in the liver — though liver concentrations drop rapidly and very little vitamin K accumulates elsewhere in the body. The body's processing of vitamin K is not fully understood; almost no unchanged phytonadione appears in the bile or urine, suggesting extensive metabolism, though the details remain unclear.

📦How to store it

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). Protect from light . Store container in closed original carton until contents have been used.

📄 Written from Phytonadione’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 →

17

Supplements & herbs that interact with Phytonadione

17 supplements and herbal products have documented interactions with Phytonadione 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 · 7
  • Minor · 9
Every supplement checked against Phytonadione — ranked by severity The full interaction hub: 1 major · 7 moderate · 9 minor · every one linked to its full report. Check Phytonadione 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 Phytonadione — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is phytonadione, and why has my doctor prescribed it?
Phytonadione is simply vitamin K1 — the same vitamin K your body uses to make clotting proteins in the liver. Your doctor has prescribed it because your blood isn't clotting properly, most likely because a medication like warfarin, an antibiotic, or a condition affecting your gut is blocking or depleting your vitamin K. By restoring vitamin K activity, phytonadione helps your liver produce the clotting factors your blood needs to stop bleeding.
How quickly will it start working?
Phytonadione is not instant. If you're receiving it by injection into a vein, you may start to see improvement in your clotting levels within one to two hours, and bleeding is usually controlled within three to six hours. Your INR — the lab test that measures how long it takes your blood to clot — can often return to a normal range within 12 to 14 hours. Oral tablets take a similar amount of time. Your care team will monitor your INR closely to see how you're responding.
I take warfarin. Will phytonadione interfere with it?
Yes — and this is important to understand. Phytonadione directly counteracts warfarin's blood-thinning effect, which is exactly why it's used when your INR is dangerously high. However, once the phytonadione has done its job, restarting warfarin may be trickier — you might temporarily need a higher dose because your body has built up some resistance. Your prescriber will guide that process carefully. Also know that phytonadione does not affect heparin, a different type of blood thinner.
What side effects should I watch out for, and when should I call for help?
Common side effects with the injectable form include flushing, dizziness, rapid heartbeat, low blood pressure, and shortness of breath. These are worth reporting to your care team. However, call for emergency help immediately if you have trouble breathing, swelling of the face or throat, chest pain, or feel like you might pass out — these could be signs of anaphylaxis, a life-threatening allergic reaction that can happen even on the first dose. Also let your doctor know if you notice unusual skin changes at or near an injection site, which can appear days to months after use.
Is it safe for my newborn to receive this injection?
Phytonadione injection is actually a standard and recommended treatment to protect newborns from a serious bleeding condition called vitamin K-deficiency bleeding. That said, there's an important safety detail: some vials of the injectable contain a preservative called benzyl alcohol, which can be harmful — even fatal — to newborns, especially premature babies. Always ask the care team to use a benzyl alcohol-free formulation if one is available. When the right formulation is used appropriately, the benefit to your baby is well established.
Do I need to take the tablet with food or anything special?
The tablet itself doesn't specifically need to be taken with food, but there is one important catch: if your bile flow is reduced — for example, due to a liver condition or after certain gut surgeries — your body can't absorb the tablet properly on its own. In that case, your prescriber will have you take bile salts alongside the tablet to help absorption. If your gut isn't absorbing medications well at all, your doctor may switch you to the injectable form instead. Always follow the specific instructions you've been given.
Is Phytonadione available over the counter?
Phytonadione 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 Phytonadione first available?
Phytonadione has been available in the United States since at least 1955, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Phytonadione?
Phytonadione is supplied by 50 manufacturers listed in the FDA NDC Directory, including Cipla USA Inc., Hospira, Inc., Henry Schein, Inc..

💬 Answers drafted from Phytonadione’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 Phytonadione comes

Phytonadione is available in 4 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

Into a muscle · Into a vein · Parenteral · Under the skin
Brands Vitamin K1
How this form is used
What it may be used for
  • Treats hypoprothrombinemia (low clotting proteins) caused by coumarin or indanedione blood thinners
  • Treats hypoprothrombinemia caused by antibiotics or other drugs such as salicylates
  • Treats hypoprothrombinemia from conditions limiting vitamin K absorption (e.g., obstructive jaundice, celiac disease, ulcerative colitis, intestinal resection, cystic fibrosis, regional enteritis)
  • Vitamin K1 Injection and Phytonadione injectable emulsion are approved for prevention and treatment of vitamin K-deficiency bleeding in newborns
Important instructions
  • Administer by the subcutaneous route whenever possible — IV and IM routes carry a risk of fatal allergic reactions
  • When IV administration is unavoidable, inject very slowly; monitor the patient closely for signs of hypersensitivity
  • Use benzyl alcohol-free formulations in neonates, infants, and pregnant or breastfeeding women whenever available
  • Protect from light at all times; inspect the solution for particles or discoloration before use
Available strengths 3 strengths
41 FDA-listed product records

Tablet

By mouth
Brands Mephyton
How this form is used
What it may be used for
  • Mephyton and Phytonadione tablets are approved for adults only — not for use in children
  • Treats hypoprothrombinemia caused by coumarin or indanedione anticoagulants in adults
  • Treats hypoprothrombinemia from antibiotics, salicylates, or other drugs that interfere with vitamin K in adults
  • Treats hypoprothrombinemia from conditions limiting vitamin K absorption (e.g., obstructive jaundice, celiac disease, ulcerative colitis, intestinal resection, cystic fibrosis, regional enteritis) in adults
Important instructions
  • Avoid the oral route if your condition prevents proper absorption from the gut
  • Bile salts must be taken alongside Mephyton or Phytonadione tablets when bile flow to the gut is reduced
  • Phytonadione tablets will not reverse the anticoagulant effects of heparin — only coumarin-type agents
  • Your prescriber will check your prothrombin time (clotting test) regularly to guide dosing
Available strengths 1 strength
27 FDA-listed product records

Other oral form

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

📊 Phytonadione across the U.S. market

How Phytonadione appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

4
Dose forms
50
Manufacturers
4
Brand names
81
FDA-listed product records
1955
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 (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Cipla USA Inc.10%
Hospira, Inc.8%
Henry Schein, Inc.8%
A-S Medication Solutions4%
Northstar Rx LLC.4%
American Health Packaging4%
Other makers61%

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

📈 How widely Phytonadione is used

A general measure of how commonly Phytonadione 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 Phytonadione 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.

12,205
Medicaid prescriptions filled (Q1–Q4 2025)
$2.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Phytonadione prescribed? Of the 1,596 medications we measure, Phytonadione ranks #894 by Medicaid prescriptions — more than 44% of them.

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

Utilization by Phytonadione 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 5 mg oral tablet is the most-dispensed Phytonadione product — about 49% of these Medicaid prescriptions.

vitamin K1 5 MG Oral Tablet Most dispensed

5,989 Medicaid prescriptions (Q1–Q4 2025) 49% of Phytonadione prescriptions shown $2.2M gross reimbursement (before rebates) ≈ $370 per prescription (gross)

Summed across the 6 of 25 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198102

1 ML vitamin K1 10 MG/ML Injection

2,999 Medicaid prescriptions (Q1–Q4 2025) 25% of Phytonadione prescriptions shown $496,342 gross reimbursement (before rebates) ≈ $166 per prescription (gross)

Summed across the 4 of 28 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1670192

0.5 ML vitamin K1 2 MG/ML Injection

2,025 Medicaid prescriptions (Q1–Q4 2025) 17% of Phytonadione prescriptions shown $120,627 gross reimbursement (before rebates) ≈ $60 per prescription (gross)

Summed across the 2 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312424

0.5 ML vitamin K1 2 MG/ML Prefilled Syringe

1,192 Medicaid prescriptions (Q1–Q4 2025) 10% of Phytonadione prescriptions shown $96,785 gross reimbursement (before rebates) ≈ $81 per prescription (gross)

Summed across the 2 of 17 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 727625

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 Phytonadione, 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 14 of 78 listed Phytonadione NDCs with Medicaid activity.

🔍 Compare Phytonadione products

A representative set of FDA-listed product records for Phytonadione — 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 81 of 81 products — FDA National Drug Code Directory. See every product, package size and price: browse all 81 Phytonadione 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) Phytonadione RxCUI 8308 6 dose forms · 8 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 373449 In current FDA listings
    Clinical drug / strength (SCD) 10 MG/ML RxCUI 312423
  2. Dose form (SCDF) Oral Capsule RxCUI 1089779 No current FDA listing
    Clinical drug / strength (SCD) 1 MG RxCUI 1089780
  3. Dose form (SCDF) Oral Tablet RxCUI 373450 In current FDA listings
    Clinical drug / strength (SCD) 5 MG RxCUI 198102 10 MG RxCUI 246313
  4. Dose form (SCDF) Prefilled Syringe RxCUI 727624 No current FDA listing
    Clinical drug / strength (SCD) 0.5 ML vitamin K1 2 MG/ML RxCUI 727625
  5. Dose form (SCDF) Sublingual Tablet RxCUI 1923354 No current FDA listing
    Clinical drug / strength (SCD) 0.5 MG RxCUI 1923355

Look up RxCUI 8308 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

Mephyton Veta-K1 Vitamin K1

🏭 Manufacturers & labelers

Cipla USA Inc. 7 Hospira, Inc. 6 Henry Schein, Inc. 6 A-S Medication Solutions 3 Northstar Rx LLC. 3 American Health Packaging 3 Agnitio Inc. 2 Zydus Pharmaceuticals USA Inc. 2 Major Pharmaceuticals 2 International Medication Systems, Limited 2 HF Acquisition Co LLC, DBA HealthFirst 2 DSM Nutritional Products, LLC 2 Chongqing Biocare Pharmaceutical Ltd. 2 AvKARE 2 Amneal Pharmaceuticals NY LLC 2 General Injectables & Vaccines, Inc. 1 Alembic Pharmaceuticals Inc. 1 Professional Compounding Centers of America dba PCCA 1 Orbicular Pharmaceutical Technologies Private Limited 1 Oceanside Pharmaceuticals 1 Alembic Pharmaceuticals Limited 1 MSN Laboratories Private Limited 1 Amneal Pharmaceuticals LLC 1 Amneal Pharmaceuticals Private Limited 1

…and 16 more on the FDA NDC directory.

RxNorm drug class

Phytonadione belongs to the Warfarin Reversal Agent class.

Pharmacologic class Warfarin Reversal Agent, Vitamin K
Drug family (ATC) Vitamin K

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 Oct 23, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Phytonadione.
📈
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 Phytonadione after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
21
NDC products indexed
81
Distinct labelers/manufacturers represented
50
Linked representative label
Amneal Pharmaceuticals LLC
Linked label effective
Oct 23, 2025
Composite sections available
21
Linked SPL Set ID
2ce1dd90-11ad-4f74-af16-45b7e59f05da
Linked SPL Document ID
a2f87d42-33cd-4706-bd3c-8b15c8095617
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. Amneal Pharmaceuticals LLC 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.