FDA-filed SPL labeling · retrieved through openFDA

Bismuth Subsalicylate

Bismuth subsalicylate is an over-the-counter digestive medicine used to relieve diarrhea, traveler's diarrhea, and upset stomach symptoms including heartburn, indigestion, nausea, gas, belching, and fullness.

Brand names BismusalKaopectatePeptic ReliefPepto-BismolPink Bismuth +11 more
Drug class Bismuth
OTC Forms 6 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 276 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 effectiveSep 1, 2026
Clinical labels in scope 276
AvailabilityOTC
Earliest approval/marketing year 1986
FDA-listed product records 774
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Bismuth Subsalicylate at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Bismuth subsalicylate is a well-known OTC option for short-term relief of diarrhea, traveler's diarrhea, and upset stomach. It should not be used in children or teens with chicken pox or flu-like illness due to the risk of Reye's syndrome, and people with salicylate allergies or ulcers should avoid it. Don't use it for more than 2 days — if symptoms persist, check in with your doctor.

📖 Bismuth Subsalicylate: Patient Information Guide

A plain-language walkthrough of Bismuth Subsalicylate — 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

Bismuth subsalicylate is an over-the-counter medicine that treats a range of common digestive problems. It is available under many brand names and in several forms.

  • Diarrhea
  • Traveler's diarrhea
  • Upset stomach due to overindulgence in food and drink
  • Heartburn
  • Indigestion
  • Nausea
  • Gas
  • Belching
  • Fullness
💊How it's taken

Bismuth subsalicylate comes in several oral forms: chewable tablets, capsules (including softgels), liquid solutions, and oral suspensions. It is taken by mouth every 30 minutes to 1 hour as needed, depending on the symptom and the specific product.

  • Chewable tablets (such as Pepto Bismol and Kroger Stomach Relief): chew completely or dissolve in the mouth before swallowing — do not swallow whole
  • Liquid and suspension products (such as Soothe and Stomach): always shake well before use and measure with the dosing cup that comes with the product — do not use any other measuring device
  • Do not exceed 8 doses in any 24-hour period, and do not use for more than 2 days for diarrhea
  • Drink plenty of clear fluids while using this medicine to prevent dehydration

Always follow the directions on your specific product label and check with your pharmacist if you are unsure.

🤒Side effects — in detail

Bismuth subsalicylate has a well-known and harmless side effect that surprises many people:

  • Darkening of the stool — your stool may turn black or very dark; this is temporary and harmless
  • Darkening of the tongue — a temporary dark discoloration that goes away on its own

Stop use and contact a doctor right away if you develop ringing in the ears or loss of hearing, or if your symptoms get worse or do not improve within 2 days.

⚠️Warnings & precautions

Reye's syndrome: This is the most critical warning. Children and teenagers who have or are recovering from chicken pox or flu-like illness must NOT use this product. Bismuth subsalicylate contains a salicylate, and salicylates have been linked to Reye's syndrome — a rare but life-threatening illness affecting the brain and liver. Watch for behavior changes combined with nausea and vomiting, and call a doctor immediately if these occur.

  • Do not use if you are allergic to salicylates or aspirin
  • Do not use if you have an ulcer, a bleeding problem, or bloody or black stools (unrelated to the medicine)
  • Ask a doctor before use if you have fever or mucus in the stool
  • Stop use and call a doctor if symptoms worsen, diarrhea lasts more than 2 days, or ringing in the ears occurs
  • Ask a health professional before use if you are pregnant or breastfeeding
🔀What it interacts with

Because bismuth subsalicylate contains a salicylate (similar to aspirin), it can interact with several types of medication. Check with your doctor or pharmacist before taking it if you use any of the following:

  • Blood thinners (anticoagulants) — salicylates can increase bleeding risk when combined with these drugs
  • Diabetes medications — salicylates may affect blood sugar control
  • Gout medications — salicylates can interfere with how these drugs work
  • Arthritis medications — some arthritis drugs are also salicylates; combining them raises the risk of side effects
  • Other salicylate products, including aspirin — do not use together; doubling up on salicylates increases the risk of side effects

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
  • Salicylate or aspirin allergy: Do not use this product if you are allergic to aspirin or any other salicylate
  • Ulcer or bleeding problem: Do not use if you have an active ulcer, a bleeding disorder, or stools that are already bloody or black
  • Children and teenagers with viral illness: Do not give to children or teens recovering from chicken pox or flu-like symptoms — risk of Reye's syndrome
  • Children under 12: Ask a doctor before use
  • Fever or mucus in stool: Ask a doctor before use — these symptoms may point to a more serious infection
  • Pregnancy and breastfeeding: Ask a health professional before use
  • Medications for blood thinning, diabetes, gout, or arthritis: Ask a doctor or pharmacist before combining with bismuth subsalicylate
🚑If you take too much

If you think someone has taken too much bismuth subsalicylate, get medical help or contact Poison Control immediately at 1-800-222-1222. Act quickly — do not wait for symptoms to appear.

📦How to store it

store at room temperature. avoid excessive heat ▪ keep this carton for future reference on full labeling TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF STRIP UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TEMPERING.

📄 Written from Bismuth Subsalicylate’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 Bismuth Subsalicylate

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

What is bismuth subsalicylate actually used for?
It's used to calm a range of stomach and digestive problems — things like diarrhea, traveler's diarrhea, heartburn, indigestion, nausea, gas, belching, and that uncomfortable over-full feeling after eating or drinking too much. It's the active ingredient in well-known brands like Pepto Bismol and Kaopectate.
Why did my stool turn black after taking this? Should I be worried?
Don't panic — that's actually a very common and completely harmless side effect of bismuth subsalicylate. The medicine can temporarily turn your stool and even your tongue a dark or grayish-black color. It goes away on its own once you stop taking the medicine. That said, if your stool was already black or bloody before you started taking it, that's a different story — don't use this product and see a doctor.
Can I give this to my child who has the flu?
No — this is a really important one. Children and teenagers who have or are recovering from the flu, chicken pox, or any flu-like illness should not take bismuth subsalicylate. It contains a salicylate, which has been linked to a rare but serious condition called Reye's syndrome that affects the brain and liver. For kids under 12 in general, always check with a doctor before giving this medicine.
How long can I take this before I should see a doctor?
For diarrhea, use it only until the diarrhea stops — and no longer than 2 days. If your diarrhea lasts more than 2 days, or if your symptoms get worse, it's time to call your doctor. Same goes if you notice ringing in your ears or any hearing changes — stop the medicine and check in with a healthcare provider.
I take aspirin and a blood thinner. Is this safe for me?
You'll want to check with your doctor or pharmacist before taking bismuth subsalicylate if you're on a blood thinner or already taking aspirin. This medicine contains a salicylate — similar to aspirin — so combining it with other salicylates or blood-thinning drugs can raise your bleeding risk. It can also interact with medications for diabetes, gout, and arthritis, so mention those too.
Can I take this if I'm pregnant or breastfeeding?
The label says to ask a health professional before using bismuth subsalicylate if you are pregnant or breastfeeding. Don't skip that step — it's worth a quick call to your OB or midwife to make sure it's appropriate for your situation.
Is Bismuth Subsalicylate available over the counter?
Yes — Bismuth Subsalicylate is available over the counter (without a prescription) in at least some forms, according to its FDA labeling. Follow the package directions and ask your pharmacist if you're unsure which product is right for you.
When was Bismuth Subsalicylate first available?
Bismuth Subsalicylate has been available in the United States since at least 1986, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Bismuth Subsalicylate?
Bismuth Subsalicylate is supplied by 156 manufacturers listed in the FDA NDC Directory, including The Procter & Gamble Manufacturing Company, Rite Aid Corporation, Strategic Sourcing Services LLC.

💬 Answers drafted from Bismuth Subsalicylate’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 Bismuth Subsalicylate comes

Bismuth Subsalicylate is available in 6 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 solution

By mouth
Brands HEB Stomach Relief Percy Medicine Pink Bismuth Soothe Stomach Relief Stomach Relief Ultra
How this form is used
What it may be used for
  • Revasol Peptic Relief liquid: relieves traveler's diarrhea, diarrhea, and upset stomach including heartburn, indigestion, nausea, gas, and belching
  • Soothe liquid: relieves diarrhea, traveler's diarrhea, and upset stomach symptoms including heartburn, indigestion, nausea, gas, belching, and fullness
Important instructions
  • Soothe: shake well before using; measure with the dosing cup provided — do not use any other device
  • Stomach liquid: shake well before using; measure with the dosing cup provided and keep cup with the product
  • Take every 30 minutes to 1 hour as needed; do not exceed 8 doses in 24 hours
  • Use until diarrhea stops, but not more than 2 days; drink plenty of clear fluids
Available strengths 8 strengths
Show 2 more strengths Show fewer strengths
313 FDA-listed product records

Chewable tablet

By mouth
Brands HEB Stomach Relief Kaopectate Meijer Stomach Relief Pepto Bismol Stomach Relief
How this form is used
What it may be used for
  • Relieves diarrhea and traveler's diarrhea
  • Relieves upset stomach due to overindulgence in food and drink, including heartburn, indigestion, nausea, gas, belching, and fullness
Important instructions
  • Pepto Bismol: fully chew or dissolve in mouth before swallowing — do not swallow whole
  • Kroger Stomach Relief: chew completely or dissolve in mouth; do not swallow tablets whole
  • Take every 30 minutes to 1 hour as needed; do not exceed 8 doses in 24 hours
  • Use until diarrhea stops, but not more than 2 days; drink plenty of clear fluids
Available strengths 2 strengths
164 FDA-listed product records

Oral suspension

By mouth
Brands HEB Stomach Relief Meijer Stomach Relief Pepto-Bismol Stomach Relief
How this form is used
What it may be used for
  • 5-Symptom Digestive Relief suspension: relieves traveler's diarrhea, diarrhea, and upset stomach including heartburn, indigestion, nausea, gas, belching, and fullness
  • Good Neighbor Ultra Strength suspension: relieves traveler's diarrhea, diarrhea, and upset stomach symptoms
  • DRx Choice Stomach Relief suspension: relieves traveler's diarrhea, diarrhea, and upset stomach including heartburn, indigestion, nausea, and gas
Important instructions
  • Shake well before each use
  • Measure with the dosing cup provided; do not use any other measuring device
  • Take every 30 minutes to 1 hour as needed; do not exceed 8 doses in 24 hours
  • Use until diarrhea stops, but not more than 2 days; drink plenty of clear fluids
Available strengths 4 strengths
135 FDA-listed product records

Tablet

By mouth
Brands Kaopectate Meijer Stomach Relief Pepto-Bismol Soothe Stomach Relief
How this form is used
What it may be used for
  • 5-Symptom Digestive Relief tablets: relieve traveler's diarrhea, diarrhea, and upset stomach including heartburn, indigestion, nausea, gas, belching, and fullness
  • Digestive Relief tablets: relieve traveler's diarrhea, diarrhea, and upset stomach including heartburn, indigestion, nausea, gas, and belching
  • Kroger Digestive Relief tablets: relieve traveler's diarrhea, diarrhea, and upset stomach symptoms including heartburn and indigestion
Important instructions
  • Take by mouth as directed on the product label
  • Do not exceed the maximum number of doses in 24 hours
  • Use until diarrhea stops, but not more than 2 days
  • Drink plenty of clear fluids to help prevent dehydration
Available strengths 3 strengths
107 FDA-listed product records

Capsule

By mouth
Brands Pepto Bismol Stomach Relief
How this form is used
What it may be used for
  • Stomach Relief capsules: relieve traveler's diarrhea, diarrhea, and upset stomach due to overindulgence in food and drink, including heartburn, indigestion, nausea, gas, belching, and fullness
  • RIGHT REMEDIES Stomach Relief softgels: relieve traveler's diarrhea, diarrhea, and upset stomach symptoms including heartburn, indigestion, nausea, gas, belching, and fullness
  • CVS Health Stomach Relief SOFTGEL: relieves traveler's diarrhea, diarrhea, and upset stomach due to overindulgence in food and drink
Important instructions
  • Take by mouth as directed on the product label
  • Do not exceed the maximum number of doses in 24 hours
  • Use until diarrhea stops, but not more than 2 days
  • Drink plenty of clear fluids to prevent dehydration
Available strengths 2 strengths
42 FDA-listed product records

Oral powder

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

📊 Bismuth Subsalicylate across the U.S. market

How Bismuth Subsalicylate 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.

6
Dose forms
156
Manufacturers
40
Brand names
774
FDA-listed product records
1986
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 (10) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

The Procter & Gamble Manufacturing Company8%
Rite Aid Corporation5%
Strategic Sourcing Services LLC5%
Quality Choice (chain Drug Marketing Association)4%
Target Corporation4%
Walgreens4%
Other makers70%

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

📈 How widely Bismuth Subsalicylate is used

A general measure of how commonly Bismuth Subsalicylate 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 Bismuth Subsalicylate 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.

65,273
Medicaid prescriptions filled (Q1–Q4 2025)
$830,496 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Bismuth Subsalicylate prescribed? Of the 1,596 medications we measure, Bismuth Subsalicylate ranks #581 by Medicaid prescriptions — more than 64% of them.

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

Utilization by Bismuth Subsalicylate 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 262 mg chewable tablet is the most-dispensed Bismuth Subsalicylate product — about 64% of these Medicaid prescriptions.

bismuth subsalicylate 262 MG Chewable Tablet Most dispensed

41,824 Medicaid prescriptions (Q1–Q4 2025) 64% of Bismuth Subsalicylate prescriptions shown $535,159 gross reimbursement (before rebates) ≈ $13 per prescription (gross)

Summed across the 5 of 173 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 308761

bismuth subsalicylate 17.5 MG/ML Oral Suspension

19,200 Medicaid prescriptions (Q1–Q4 2025) 29% of Bismuth Subsalicylate prescriptions shown $242,654 gross reimbursement (before rebates) ≈ $13 per prescription (gross)

Summed across the 5 of 220 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 308762

bismuth subsalicylate 35 MG/ML Oral Suspension

2,950 Medicaid prescriptions (Q1–Q4 2025) 5% of Bismuth Subsalicylate prescriptions shown $33,482 gross reimbursement (before rebates) ≈ $11 per prescription (gross)

Summed across the 3 of 94 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 308763

bismuth subsalicylate 262 MG Oral Tablet

1,299 Medicaid prescriptions (Q1–Q4 2025) 2% of Bismuth Subsalicylate prescriptions shown $19,201 gross reimbursement (before rebates) ≈ $15 per prescription (gross)

Summed across the 3 of 44 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 308760

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 Bismuth Subsalicylate, 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 16 of 531 listed Bismuth Subsalicylate NDCs with Medicaid activity.

🔍 Compare Bismuth Subsalicylate products

A representative set of FDA-listed product records for Bismuth Subsalicylate — 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 774 products — FDA National Drug Code Directory. See every product, package size and price: browse all 774 Bismuth Subsalicylate 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) Bismuth Subsalicylate RxCUI 19478 6 dose forms · 10 strengths
  1. Dose form (SCDF) Chewable Tablet RxCUI 371099 In current FDA listings
    Clinical drug / strength (SCD) 262 MG RxCUI 308761
  2. Dose form (SCDF) Oral Capsule RxCUI 2121071 In current FDA listings
    Clinical drug / strength (SCD) 262 MG RxCUI 2121072
  3. Dose form (SCDF) Oral Powder RxCUI 1191694 In current FDA listings
    Clinical drug / strength (SCD) 525 MG RxCUI 1191695
  4. Dose form (SCDF) Oral Suspension RxCUI 371100 In current FDA listings
    Clinical drug / strength (SCD) 17.4 MG/ML RxCUI 422011 17.5 MG/ML RxCUI 308762 35 MG/ML RxCUI 308763 105 MG/ML RxCUI 616343
  5. Dose form (SCDF) Oral Tablet RxCUI 371101 In current FDA listings
    Clinical drug / strength (SCD) 262 MG RxCUI 308760 525 MG RxCUI 1998447
  6. Dose form (SCDF) Powder for Oral Suspension RxCUI 1721448 In current FDA listings
    Clinical drug / strength (SCD) 262 MG RxCUI 1721449

Look up RxCUI 19478 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

Bismusal Kaopectate Peptic Relief Pepto-Bismol Pink Bismuth Stomach Relief Kaopectate Reformulated Aug 2006 Percy Medicine Estomaquil Bismarex Stomach Relief Regular Strength Pepto Bismol Soothe Stomach Relief Ultra Meijer Stomach Relief HEB Stomach Relief

🏭 Manufacturers & labelers

The Procter & Gamble Manufacturing Company 41 Rite Aid Corporation 24 Strategic Sourcing Services LLC 24 Quality Choice (chain Drug Marketing Association) 22 Target Corporation 22 Walgreens 20 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 18 P & L Development, LLC 18 Kramer Laboratories 17 Meijer Distribution Inc 16 H E B 15 Family Dollar (FAMILY WELLNESS) 14 The Kroger Co. 14 Spirit Pharmaceuticals LLC 13 Lil' Drug Store Products, Inc. 13 Best Choice (Valu Merchandisers Company) 13 Kroger Company 13 Care One (Retail Business Services, LLC.) 12 Procter & Gamble Manufactura S de RL de CV 12 Cvs Pharmacy 11 Topco Associates Llc 11 Amerisource Bergen 10 CVS Pharmacy, Inc. 10 Safeway 10

…and 16 more on the FDA NDC directory.

RxNorm drug class

Bismuth Subsalicylate belongs to the Bismuth class.

Pharmacologic class Bismuth

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 Sep 1, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Bismuth Subsalicylate.
📈
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 Bismuth Subsalicylate after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
276
NDC products indexed
774
Distinct labelers/manufacturers represented
156
Linked representative label
Kroger Company
Linked label effective
Sep 1, 2026
Composite sections available
7
Linked SPL Set ID
4963f568-9d8d-4ad0-b840-bed3f6f9cb7b
Linked SPL Document ID
0603a7fb-f15b-4033-90e6-0d5219bddfb6
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 276 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. Kroger Company 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.