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McKesson Bismuth bismuth subsalicylate 262 mg Tablet, Chewable — NDC 68599-4744-07 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

McKesson Bismuth bismuth subsalicylate 262 mg Tablet, Chewable — NDC 68599-4744-7 (Billing 68599-4744-07)

by McKesson Medical-Surgical · 100 PACKET in 1 BOX / 2 TABLET, CHEWABLE in 1 PACKET

This is a package of McKesson Bismuth bismuth subsalicylate 262 mg Tablet, Chewable from McKesson Medical-Surgical, marketed since Mar 2022 and currently FDA-listed; retail pharmacies pay about $0.0817 per unit (NADAC). It is this product's only package size.

NDC 68599-4744-07
🏷️ FDA NDC (as labeled) 68599-4744-7 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 68599-4744-7 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
68599 labeler · 4744 product · 7 package
Package marketed since
Mar 1, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6859947447 4
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68599-4744-7
Product NDC 68599-4744
11-digit billing NDC 68599474407
RxCUI 308761
UNII 62TEY51RR1
Application # M008
SPL Set ID d1f3dfa4-e021-6384-e053-2995a90a7b42
Established class (EPC) Bismuth
Chemical class Bismuth
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-03-01
Route ORAL
Dosage form TABLET, CHEWABLE
Substance BISMUTH SUBSALICYLATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 002860
GCN 08420
HICL code 001246
Ingredient (HICL) Bismuth Subsalicylate
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Colon
HIC3 code D6D
Therapeutic class — specific (HIC3) Antidiarrheals
AHFS code 56:04.00.00
AHFS class Antacids And Adsorbents
FDB label name BISMUTH 262 MG TABLET CHEW
FDB brand name Bismuth
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 002860
  • GCN: 08420
  • HICL (First Databank): 001246
  • AHFS class code: 56:04.00.00
  • RxCUI (RxNorm): 308761
Why two NDCs? The FDA registers this code as 68599-4744-7 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 68599-4744-07. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Bismuth class.

Pharmacologic class Bismuth
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name BISMUTH 262 MG TABLET CHEW Ingredient Bismuth Subsalicylate
📖 What it is MedlinePlus · NLM

Bismuth subsalicylate is used to treat diarrhea, heartburn, and upset stomach in adults and children 12 years of age and older. Bismuth subsalicylate is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel, reduces inflammation within the intestine, and may kill the organisms that can cause diarrhea.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It relieves diarrhea, including traveler's diarrhea. It also helps with upset stomach after overindulging in food and drink, such as heartburn, indigestion, nausea, gas, belching a...
  • Use it only until the diarrhea stops, and no more than 2 days. If you're not better by then, or you get worse sooner, stop and see a doctor. Drink plenty of clear fluids while you...
  • That's a known, temporary and harmless effect of this medicine. But black stool can also signal bleeding, so do not use it if you already have bloody or black stool.
  • Children under 12 should be checked by a doctor first. Children and teens who have or are recovering from chicken pox or flu-like symptoms should not use it because of Reye's syndr...
📖 Read our full Bismuth Subsalicylate guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.082 $16.34 / 200 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.084 $0.081
▼ Down 3% over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68599-4744-07 You're viewing this Main listing 100 PACKET in 1 BOX / 2 TABLET, CHEWABLE in 1 PACKET 2022-03-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Major Bismuth Subsalicylate 262 mg 00904-7205-46 Major 6 tablets $0.082 — Availability likely —
GNP Pink Bismuth 262 mg 46122-0701-65 Amerisource 6 tablets $0.082 — Availability likely —
McKesson Bismuth 262 mgthis 68599-4744-07 McKesson 2 tablets $0.082 — Availability likely —
Foster and Thrive Stomach Relief 262 mg 70677-1080-01 Strategic 6 tablets $0.082 — Availability likely —
Stomach Relief 262 mg 83324-0130-30 Chain 30 tablets $0.082 — Availability likely —
Stomach Relief 262 mg 70000-0591-01 CARDINAL 6 tablets $0.083 — FDA listed +1%
Walgreen Stomach Relief 262 mg 00363-1423-30 WALGREENS 6 tablets — — FDA listed —
Walgreen 262 mg 00363-9124-30 WALGREEN 30 tablets — — FDA listed —
Walgreens Bismuth Stomach Relief 262 mg 00363-9954-24 Walgreens 24 tablets — — FDA listed —
5 Symptom Digestive Relief 262 mg 11673-0723-48 TARGET 6 tablets — — FDA listed —
Rite Aid Stomach Relief Original Flavor 262 mg 11822-2430-00 RITE 6 tablets — — FDA listed —
Rite Aid Stomach Relief 262 mg 11822-4320-00 RITE 6 tablets — — FDA listed —
Pepto Relief 262 mg 17714-0045-30 Advance 30 tablets — — FDA listed —
Stomach Relief 262 mg 21130-0241-30 SAFEWAY 6 tablets — — FDA listed —
Kroger Stomach Relief 262 mg 30142-0324-30 KROGER 30 tablets — — FDA listed —
Pepto Bismol Chews 262 mg 37000-0996-24 The 24 tablets — — FDA listed —
HEB Stomach Relief Cherry 262 mg 37808-0587-77 H 6 tablets — — FDA listed —
HEB Stomach Relief 262 mg 37808-0937-77 H 6 tablets — — FDA listed —
Equaline Stomach Relief 262 mg 41163-0058-49 UNITED 6 tablets — — FDA listed —
meijer stomach relief 262 mg 41250-0878-30 Meijer 30 tablets — — FDA listed —
Chewable Stomach Relief 262 mg 41415-0124-30 PUBLIX 6 tablets — — FDA listed —
Bismuth Subsalicylate Pink Bismuth 262 mg 42507-0267-77 Hyvee 6 tablets — — FDA listed —
First Aid Direct Peptum Tabs 262 mg 42961-0109-02 Cintas 1 tablet — — FDA listed —
Medique Diotame 262 mg 47682-0210-13 Unifirst 2 tablets — — FDA listed —
Medi-First Pep-T-Med 262 mg 47682-0406-20 Unifirst 6 tablets — — FDA listed —
Pepto Bismol Chewable 5 Symptoms Relief 262 mg 50269-0555-01 JC 2 tablets — — FDA listed —
Goodsense Regular strength Stomach Relief 122 262 mg 50804-0152-49 Good 30 tablets — — FDA listed —
Stomach Relief 262 mg 51013-0321-54 PuraCap 2 tablets — — FDA listed —
CVS Stomach Relief 262 mg 51316-0124-48 CVS 48 tablets — — FDA listed —
Guardian Pink Bismuth 262 mg 53041-0021-41 Guardian 6 tablets — — FDA listed —
Guardian Pink-Bismuth Cherry 262 mg 53041-0022-49 Guardian 6 tablets — — FDA listed —
Pep Tum 262 mg 53117-0046-85 First 1 tablet — — FDA listed —
Pink Bismuth 262 mg 53943-0122-35 Discount 6 tablets — — FDA listed —
Pepto Relief 262 mg 54738-0102-30 Richmond 30 tablets — — FDA listed —
Stomach Relief 262 mg 55301-0124-30 YOUR 30 tablets — — FDA listed —
Family wellness Stomach Relief 262 mg 55319-0122-49 Family 6 tablets — — FDA listed —
Kaopectate 262 mg 55505-0206-69 Kramer 24 tablets — — FDA listed —
Regular Strength Stomach Relief 262 mg 55910-0204-30 DOLGENCORP, 6 tablets — — FDA listed —
Pepto Bismol CHEWABLES 262 mg 58933-0002-12 Procter 2 tablets — — FDA listed —
Pepto Bismol CHEWABLES 262 mg 58933-0011-02 Procter 2 tablets — — FDA listed —
Pepto Bismol CHEWABLES 525 mg/21 58933-0013-02 Procter 2 tablets — — FDA listed —
Stomach Relief 262 mg 63868-0622-30 CDMA- 30 tablets — — FDA listed —
Pepto-Bismol Chewable, TRAVEL BASIX 262 mg 66715-6423-02 Lil' 2 tablets — — FDA listed —
Pepto-Bismol Chewable, CVP HEALTH 262 mg 66715-6523-02 Lil' 2 tablets — — FDA listed —
Stomach Relief, 24-7 Life by 7-Eleven 262 mg 66715-8153-03 Lil' 2 tablets — — FDA listed —
Pepto-Bismol 262 mg 66715-9723-02 Lil' 2 tablets — — FDA listed —
WinCo FOODS Stomach Relief 262 mg 67091-0364-30 WINCO 6 tablets — — FDA listed —
Pepto Bismol 262 mg 67751-0155-01 Navajo 2 tablets — — FDA listed —
Premier Value 262 mg 68016-0124-30 CHAIN 30 tablets — — FDA listed —
Goodsense Regular strength Stomach Relief 122 262 mg 68788-4002-03 Preferred 30 tablets — — FDA listed —
Bismuth Subsalicylate 262 mg 68788-4116-03 Preferred 30 tablets — — FDA listed —
Major Bismuth Subsalicylate 262 mg 68788-8239-03 Preferred 6 tablets — — FDA listed —
Bismuth Chewable 262 mg 68998-0046-88 Marc 1 tablet — — FDA listed —
Bismuth 262 mg 69168-0046-69 Allegiant 12 tablets — — FDA listed —
Gastrobiz 262 mg 69168-0999-98 Allegiant 1 tablet — — FDA listed —
Pepto Bismol Fast Melts Fresh Berry Flavored 262 mg 69423-0831-24 The 24 tablets — — FDA listed —
Pepto Bismol Fast Melts Winter Frost Flavored 262 mg 69423-0832-24 The 24 tablets — — FDA listed —
Pepto Bismol Chews 262 mg 69423-0963-24 The 24 tablets — — FDA listed —
Bismuth Subsalicylate 262 mg 69618-0029-03 Reliable 30 tablets — — FDA listed —
CVS Health Stomach relief Cherry Flavor 262 mg 69842-0221-12 CVS 12 tablets — — FDA listed —
Stomach Relief 262 mg 69842-0394-54 CVS 2 tablets — — FDA listed —
Careone Stomach Relief 262 mg 72476-0173-72 Retail 5 tablets — — FDA listed —
Thompson Chewable Bismuth Tabs 262 mg 73408-0407-20 Thompson 6 tablets — — FDA listed —
Pept-Ache 262 mg 73598-1232-01 JHK 1 tablet — — FDA listed —
Topcare Stomach Relief Original Strength 262 mg 76162-0001-85 TopCo 30 tablets — — FDA listed —
TopCare Bismuth Stomach Relief 262 mg 76162-0406-24 TopCo 24 tablets — — FDA listed —
Meijer Bismuth Stomach Relief 262 mg 79481-0097-01 Meijer 24 tablets — — FDA listed —
Equate Stomach Relief 262 mg 79903-0089-49 Wal-Mart 6 tablets — — FDA listed —
Equate Bismuth Stomach Relief Chew 262 mg 79903-0219-24 Walmart 24 tablets — — FDA listed —
Wonderbelly Multi-Symptom 262 mg 82431-0301-04 Ginger 4 tablets — — Discontinued —
Wonderbelly Multi-Symptom 262 mg 82431-0302-04 Ginger 4 tablets — — Discontinued —
Wonderbelly Multi-Symptom 262 mg 82431-0304-04 Ginger 4 tablets — — Discontinued —
Wonderbelly Multi-Symptom 82431-0391-12 Ginger 12 tablets — — Discontinued —
Pepto Bismol 262 mg 84126-0321-70 The 70 tablets — — FDA listed —
Stomach Relief 262 mg 85828-0727-30 Grocery 6 tablets — — FDA listed —
Pepto Bismol CHEWABLES 262 mg 85237-1903-01 Select 2 tablets — — FDA listed —
Pepto Bismol Fast Melts 262 mg 84126-0388-24 The 24 tablets — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
On the market since
Mar 2022
📍
2026
Currently FDA-listed
4 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Bismuth Subsalicylate inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 5C5403N26O
    Acacia is a natural gum derived from acacia tree sap. It serves as a binder, thickener, and emulsifier to help hold ingredients together, improve texture, and stabilize the medicine.
  • UNII Z0H242BBR1
    Aspartame is an artificial sweetener made from amino acids. It's added to medicines to improve taste, making bitter or unpleasant-tasting drugs easier to take.
  • UNII H0G9379FGK
    Calcium carbonate is a white mineral powder used as a filler and buffering agent in medicines. It helps give tablets their bulk and size while neutralizing stomach acid in some formulations.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 2LRS185U6K
    D&C Red No. 27 is a synthetic red colorant used in medicines and cosmetics. It gives tablets, capsules, or liquids their red or reddish color so products are visually identifiable.
  • UNII G263MI44RU
    Dextrates are a carbohydrate mixture made from corn or potato starch. They work as fillers and binders in tablets and capsules to add bulk and help hold the medicine together.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.

9 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesInactive ingredients acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerMcKesson Medical-Surgical
FDA applicationM008 (OTC MONOGRAPH DRUG)
Labeler code68599
First marketedMar 2022
Product typeHuman Otc Drug
Portfolio18 products on file

More NDCs from McKesson Medical-Surgical labeler code 68599

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 28 words ▾

Uses relieves traveler's diarrhea diarrhea upset stomach reliever due to overindulgence in food and drink, including: • heartburn • indigestion • nausea • gas • belching • fullness

⏱️ Dosage and Administration 61 words ▾

Directions chew or dissolve in mouth drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea Adults and children: (12 years and over) chew 2 tablets every 1/2 to 1 hour as needed do not exceed 16 tablets in 24 hours use until diarrhea stops but not more than 2 days Children under 12 years: Ask a doctor

⚠️ Warnings 73 words ▾

Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome a rare but serious illness. Allergy alert: Contains salicylate.

Do not take if you are: allergic to salicylates (including aspirin) taking other salicylate products

🧪 Active Ingredient 15 words ▾

Active ingredient (in each tablet) Bismuth Subsalicylate 262 mg (each tablet contains 102 mg salicylate)

🧪 Inactive Ingredients 22 words ▾

Inactive ingredients acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide

🎯 Purpose 2 words ▾

Purpose antidiarrheal/antacid

📄 Do Not Use 15 words ▾

Do not use if you have bloody or black stool an ulcer a bleeding problem

📄 Ask a Doctor Before Use If 13 words ▾

Ask a doctor before use if you have​ fever mucus in the stool

📄 Ask a Doctor or Pharmacist Before Use If 20 words ▾

Ask a doctor or pharmacist if you are taking any drug for anticoagulation (thinning of the blood) diabetes gout arthritis

📄 When Using This Product 16 words ▾

When using this product a temporary and harmless darkening of the tongue and/or stool may occur.

📄 Stop Use and Ask a Doctor If 31 words ▾

Stop use and ask a doctor if symptoms get worse or lasts more than 2 days ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of accidental overdose, contact a physician or poison control center right away (1-800-222-1222).

📄 Other Information 32 words ▾

Other information phenylketonurics: contains phenylalanine 1.1 mg per tablet calcium content per tablet: 73 mg store at room temperature 59°-86°F (15°-30°C) tamper-evident sealed packets do not use any opened or torn packets

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-777-4908

📄 Package Label / Principal Display Panel 22 words ▾

NDC 68599-4744-7 McKesson Bismuth Tablets 262 mg Bismuth Suybsalicylate 2 Per Pack | 100 Packs Per Box MFR # 82473 220R Bismuth

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Bismuth subsalicylate — the ingredient across all brands.

Top reported reactions

Chronic Kidney Disease1,418
Acute Kidney Injury822
Diarrhoea756
Renal Failure725
Nausea654
End Stage Renal Disease467
Vomiting434

Age at onset

Child6
Adolescent5
Adult367
Elderly368

Reporter sex

5,774 reports
Male · 38%
Female · 62%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,033 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 68599-4681-03 · McKesson 68599-4751-03 · McKesson →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.