What this pack is
FLOMAX is the brand name in this record; tamsulosin hydrochloride capsules is the generic name. Read both together with the dosage form (oral capsule).
PACK CHECK · MARKET FIRST
FLOMAXGeneric nametamsulosin hydrochloride capsules
How this medicine works
The label describes tamsulosin as an alpha-1 adrenergic receptor blocker that can relax smooth muscle in the prostate and bladder neck and improve urine flow. The mechanism also helps explain orthostatic-hypotension boundaries but cannot select an individual dose, combination or substitute.
Read source: United States ↗reviewed 2026-09-04More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- International brand name
- FLOMAX
- Source-scoped market brand names
- FLOMAX · U.S. historical brand archiveSource-scoped evidence ↗NDA 020579; 0.4 mg, NDC 0024-5837-01, 100-capsule bottle; the public marketing record ended 31 Oct 2025.
The evidence status and note below apply only to the stated market and source. They do not prove that packs in different markets can be substituted.
- Generic name
- tamsulosin hydrochloride capsules
- Dosage-form class
- Tamsulosin hydrochloride immediate-release oral hard capsules, 0.4 mg. The 0.4 mg figure is the labelled amount per capsule and 100 is the number of capsules in the displayed brand bottle. The capsule must not be crushed, chewed or opened; these fields cannot become an individual dosing, restart, escalation, stopping or substitution plan.
- Route
- Oral
- Package-image status
- No exact original-brand package image is shown This is deliberate: do not use a retailer, repackager or another-market image to identify the pack in hand. See why and what to check instead →
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
How to read a score line: ‘scored’ or ‘unscored’ first identifies this labelled presentation. A score line by itself does not permit self-splitting, reducing or changing the product. Only an explicit statement in the current label for this exact presentation, checked with a pharmacist against the prescription, can support any further handling.
1 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · U.S. DailyMed brand label (SPL v10; effective 2 Jan 2025)
Tamsulosin hydrochloride 0.4 mg per capsule; 100-capsule bottle
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 0024-5837-01
- Form and route
- FLOMAX tamsulosin hydrochloride 0.4 mg oral hard capsule · oral (product-identity field)
- Container
- bottle
- Listing review
- Cited product evidence reviewed 2026-09-04; actual marketing, stock and availability are not established.
- tamsulosin hydrochloride
- 0.4 mglabelled amount per capsule; not an individual dosing, restart or escalation instruction
- Package
- 100 capsules per bottle
- Labelled appearance
- olive-green opaque cap and orange opaque body · 19 mm hard capsule; unscored; capsule must not be crushed, chewed or opened · imprint Flomax; 0; 4; mg; BI; 58Unscored; do not crush, chew or open this labelled presentation
PACKAGE-VISUAL STATUS
Brand text identity is complete; the official package-image endpoint was unusable
The DailyMed brand label lists FLOMAX, NDA 020579, NDC 0024-5837-01, 0.4 mg per capsule, a 100-capsule bottle, capsule colours, 19 mm size and the BI 58 imprint; however, its official package-image endpoint returned no usable image content during review. The site therefore shows text identity only and does not substitute a placeholder, search image or repackaged image, or use it for authenticity, supply or purchase decisions.
LABEL READING · NOT A PRESCRIPTION
Enlarged FLOMAX label: 0.4 mg, intact swallowing, dizziness/falls and surgical disclosure
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
This module identifies per-capsule strength, capsule integrity, orthostatic hypotension, interactions and eye-surgery disclosure. Label dosing and restart paragraphs are not converted into an individual plan.
- The label uses FLOMAX for signs and symptoms of benign prostatic hyperplasia and states that it is not indicated for hypertension. Urinary symptoms, dizziness or the words alpha blocker do not support self-switching or combining medicines.
- The capsule should remain intact and must not be crushed, chewed or opened. The 0.4 mg figure is a labelled amount per capsule, not a website-derived rule for starting, restarting, increasing, replacing missed doses or stopping.
- Dizziness on standing, hypotension or syncope may lead to falls. Older adults, people rising at night and those using other blood-pressure-affecting medicines should have the exact pack, symptoms and complete medicine list reviewed by a clinician or pharmacist.
- Before cataract or glaucoma surgery, tell the eye-care team about current or past tamsulosin use. The label also says the benefit of stopping before surgery has not been established, so do not stop it from a web page.
- Syncope, an injurious fall or severe weakness needs timely medical assessment. A painful erection lasting hours is an emergency signal requiring immediate local emergency care.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-09-04
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 2
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeDailyMed (NLM): U.S. FLOMAX tamsulosin hydrochloride 0.4 mg brand label (SPL v10; effective 2 Jan 2025) ↗reviewed 2026-09-04
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- U.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-09-04DailyMed (NLM): FLOMAX tamsulosin hydrochloride brand electronic label PDF ↗reviewed 2026-09-04
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about FLOMAX (tamsulosin hydrochloride capsules). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
FLOMAX is the brand in this record and tamsulosin hydrochloride capsules is the active-ingredient name. Check both with the dosage form (Tamsulosin hydrochloride immediate-release oral hard capsules, 0.4 mg. The 0.4 mg figure is the labelled amount per capsule and 100 is the number of capsules in the displayed brand bottle. The capsule must not be crushed, chewed or opened; these fields cannot become an individual dosing, restart, escalation, stopping or substitution plan.) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
HOW IT WORKS · NOT A TREATMENT PLAN
How tamsulosin works: relaxing prostate and bladder-neck smooth muscle does not shrink the prostate or treat hypertension
- FLOMAX, UROXATRAL, RAPAFLO, HYTRIN, CARDURA and MINIPRESS are different ingredients or products. Related pharmacology creates no milligram conversion, alternation, combination or substitution rule.
- It does not shrink the prostate and is not indicated for hypertension. Mechanism cannot replace assessment of symptoms, blood pressure, falls, surgical plans and the complete medicine list.
- The same generic name can still have different manufacturers, excipients, packs, markets and label dates. A shared mechanism cannot prove authenticity, current supply or self-substitutability.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- DailyMed (NLM): U.S. FLOMAX tamsulosin hydrochloride 0.4 mg brand label (SPL v10; effective 2 Jan 2025) ↗reviewed 2026-09-04
- DailyMed (NLM): FLOMAX tamsulosin hydrochloride brand electronic label PDF ↗reviewed 2026-09-04
- FDA: 1997 original approval package for FLOMAX (NDA 020579) ↗Historical public record · reviewed 2026-09-04
- FDA: FLOMAX NDA 020579/S-029 supplemental approval letter (29 Sep 2014) ↗Historical public record · reviewed 2026-09-04
SOURCE-TRACEABLE ARCHIVE
FLOMAXtamsulosin hydrochloride capsules
This page links to public primary-source material for FLOMAX. The archive is historical or documentary evidence only; it does not by itself establish originator status, product quality, current labelling, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
FDA approval of the FLOMAX NDA
The FDA original approval package records approval of NDA 020579.
FDA: 1997 original approval package for FLOMAX (NDA 020579) ↗FDA approval of the S-029 labelling supplement
The supplement approval letter records the corresponding label update.
FDA: FLOMAX NDA 020579/S-029 supplemental approval letter (29 Sep 2014) ↗DailyMed SPL v10 became effective
This version preserves the 0.4 mg brand capsule, 100-capsule bottle and textual appearance clues.
DailyMed (NLM): U.S. FLOMAX tamsulosin hydrochloride 0.4 mg brand label (SPL v10; effective 2 Jan 2025) ↗Marketing record ended for the displayed brand NDC
This is a regulatory-listing field, not proof of global discontinuation or any channel's stock.
DailyMed (NLM): U.S. FLOMAX tamsulosin hydrochloride 0.4 mg brand label (SPL v10; effective 2 Jan 2025) ↗
MARKET SCOPE
Market-record boundary
U.S. FLOMAX brand pack
Marketing record ended for the displayed NDC0.4 mg, NDC 0024-5837-01, 100-capsule bottle; end date 31 Oct 2025.
Other manufacturers and markets
Not individually established in this dossierThis U.S. brand record cannot establish approval, supply, price, authenticity or substitutability in Mainland China, the EU, Japan or another market.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
Keep international and mainland China records separate
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
RECORD FAQ
Record questions
Is FLOMAX a blood-pressure medicine?
No. The U.S. brand label explicitly states it is not indicated for hypertension. It can still cause orthostatic hypotension, dizziness or syncope, so the full medicine list and fall risk need professional review.
Can the 0.4 mg capsule be opened or crushed?
The label explicitly says the capsule must not be crushed, chewed or opened. Ask the prescriber or pharmacist about swallowing or dosage-form concerns rather than altering the capsule.
Can it be restarted the same way after several missed days?
This page does not provide a restart plan. The label has a specific restart paragraph, and hypotension, syncope, co-medications and individual factors affect the decision; contact the prescribing team.
Does the ended brand marketing record mean tamsulosin is unavailable?
No. The date applies only to the displayed U.S. brand NDC; it proves neither global discontinuation nor live stock for other manufacturers, markets or channels.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.