What this pack is
Spiriva Respimat is the brand name in this record; tiotropium bromide inhalation spray is the generic name. Read both together with the dosage form (inhaled product).
PACK CHECK · MARKET FIRST
Spiriva RespimatGeneric nametiotropium bromide inhalation spray
How this medicine works
The current label describes tiotropium as an anticholinergic bronchodilator; in the airways it has bronchodilation-related effects through inhibition of M3 receptors on smooth muscle. Mechanism explains an action pathway, not whether an individual is suitable, which device is needed, whether another inhaler should be combined, or how to self-manage symptoms.
Read source: United States ↗reviewed 2026-08-22More 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
- Spiriva Respimat
- Generic name
- tiotropium bromide inhalation spray
- Dosage-form class
- SPIRIVA RESPIMAT metered inhalation spray: 1.25 mcg or 2.5 mcg per labelled actuation; dedicated inhaler-and-cartridge system (as listed in DailyMed SPL v16)
- Route
- Oral inhalation
- Package-image status
- A source-linked public label image is available below
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
A mcg-per-inhalation value identifies the labelled contents of this exact inhaler. It does not calculate an individual's inhalation count, timing, acute-symptom action, combination or switch.
2 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 · DailyMed SPL v16 (published 19 Aug 2026)
Tiotropium 1.25 mcg per labelled actuation; one RESPIMAT inhaler plus one dedicated cartridge (60 labelled actuations)
- Product code
- NDC 0597-0160-61
- Form and route
- SPIRIVA RESPIMAT metered inhalation spray; dedicated inhaler-and-cartridge system · oral inhalation
- Container
- RESPIMAT inhaler with dedicated aluminium cartridge system
- Units in each inner container
- 60 labelled actuationsPackage identity only; not an individual amount to take
- Delivery device
- RESPIMAT inhaler
- Listing review
- Cited public label display reviewed 2026-08-22; actual marketing, stock and availability are not established.
- tiotropium
- 1.25 mcglabelled ingredient amount per actuation; not an individual's use count or regimen
- Package
- 1 inhaler plus cartridge per carton (60 labelled actuations)
- Labelled appearance
- blue cap and corresponding label panel · grey cylindrical device with clear base; dedicated cartridge
United States label · DailyMed SPL v16 (published 19 Aug 2026)
Tiotropium 2.5 mcg per labelled actuation; one RESPIMAT inhaler plus one dedicated cartridge (60 labelled actuations)
- Product code
- NDC 0597-0100-61
- Form and route
- SPIRIVA RESPIMAT metered inhalation spray; dedicated inhaler-and-cartridge system · oral inhalation
- Container
- RESPIMAT inhaler with dedicated aluminium cartridge system
- Units in each inner container
- 60 labelled actuationsPackage identity only; not an individual amount to take
- Delivery device
- RESPIMAT inhaler
- Listing review
- Cited public label display reviewed 2026-08-22; actual marketing, stock and availability are not established.
- tiotropium
- 2.5 mcglabelled ingredient amount per actuation; not an individual's use count or regimen
- Package
- 1 inhaler plus cartridge per carton (60 labelled actuations)
- Labelled appearance
- aqua cap and corresponding label panel · grey cylindrical device with clear base; dedicated cartridge
PUBLIC LABEL IMAGE
Appearance and package-text clues
This current public-label package panel helps check the brand, generic name, strength and dosage-form clues only. It does not authenticate a product in hand or establish originator status, availability, sale eligibility, another package or another market.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
SPIRIVA RESPIMAT label reading: check the spray device and cartridge before the per-actuation label amount
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 uses the current U.S. DailyMed SPL v16 label to distinguish SPIRIVA RESPIMAT, tiotropium, the labelled amount per actuation, 60 labelled actuations, the dedicated inhaler and its dedicated cartridge. It does not reproduce anyone's device steps, actuation count, interval, missed-use action, escalation, substitution or acute-breathing plan.
- “1.25 mcg / 2.5 mcg per actuation” is a label-identity field for one actuation from this spray device, not a webpage answer to how many times anyone should use it in a day. Check the exact product name, cap colour, NDC, inhaler, cartridge, target market and prescription label together.
- The label says the cartridge is only for the SPIRIVA RESPIMAT inhaler and is not to be interchanged with another RESPIMAT device product. Similar device names, a shared ingredient, both saying “inhalation,” or the same brand family do not establish self-interchangeability of a device, cartridge or strength.
- SPIRIVA HANDIHALER is an inhalation-powder capsule with a HandiHaler device; RESPIMAT is a spray inhaler with a cartridge. A HandiHaler “18 mcg capsule” is neither a RESPIMAT cartridge nor a swallowed capsule, and a shared generic name or microgram number does not establish a switch.
- The label distinguishes this product from immediate relief of acute bronchospasm. Sudden or worsening breathlessness, wheeze, chest tightness or uncertainty about the device needs local urgent-care pathways and an existing care plan, with the actual device and full medicine list reviewed by a pharmacist or clinician.
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 · 2026-08-22
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 · 1
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): current U.S. SPIRIVA RESPIMAT tiotropium bromide metered-inhalation-spray public label (Boehringer Ingelheim; SPL v16, published 19 Aug 2026) ↗reviewed 2026-08-22
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 Spiriva Respimat (tiotropium bromide inhalation spray). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
Spiriva Respimat is the brand in this record and tiotropium bromide inhalation spray is the active-ingredient name. Check both with the dosage form (SPIRIVA RESPIMAT metered inhalation spray: 1.25 mcg or 2.5 mcg per labelled actuation; dedicated inhaler-and-cartridge system (as listed in DailyMed SPL v16)) and the market on the actual pack.
Read the labelled strength in context
mcg per actuation, dose count or a two-number strength describes the labelled inhaler and device identity. It is not an individual inhalation count or rescue plan.
Check the exact inhaler or device
For an inhaled product, verify the device, labelled strength and current instructions for that exact pack. Do not transfer, share or replace a device on the basis of a similar name.
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.
HOW IT WORKS · NOT A TREATMENT PLAN
How tiotropium works: it is a long-acting antimuscarinic medicine acting at M3 receptors in airway smooth muscle
- “Anticholinergic” is one clue for reviewing related medicines and the complete medicine list; it does not permit self-combining, alternating or converting RESPIMAT with another anticholinergic inhaler, oral medicine, patch or eye medicine. Have a pharmacist or clinician review every actual medicine and device.
- An M3-receptor mechanism does not make a same-ingredient HandiHaler capsule, RESPIMAT cartridge, another spray device or another-market product the same identity. Product form, cartridge-device pairing, label version, market and prescribing purpose all need to be checked together.
- Eye pain, blurred vision, difficulty passing urine, a serious allergy-like reaction or changing breathing symptoms cannot be used with a mechanism page to decide self-escalation, stopping or changing devices. Use local urgent-care pathways and professional advice.
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): current U.S. SPIRIVA RESPIMAT tiotropium bromide metered-inhalation-spray public label (Boehringer Ingelheim; SPL v16, published 19 Aug 2026) ↗reviewed 2026-08-22
- FDA Drugs@FDA official search entry ↗Official lookup entry · reviewed 2026-08-20
SOURCE-TRACEABLE ARCHIVE
Spiriva Respimattiotropium bromide inhalation spray
This page includes an exact current U.S. public-label package panel for Spiriva Respimat, alongside documentary primary-source material. It helps check product identity, but does not itself establish originator status, product quality, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
Initial U.S. approval year listed in the current label
The current SPIRIVA RESPIMAT label lists Initial U.S. Approval: 2004. This year only locates this U.S. public label; it does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in another market.
DailyMed (NLM): current U.S. SPIRIVA RESPIMAT tiotropium bromide metered-inhalation-spray public label (Boehringer Ingelheim; SPL v16, published 19 Aug 2026) ↗DailyMed published current SPL v16
The DailyMed media catalogue identifies this SPIRIVA RESPIMAT label as SPL v16 and lists publication on 19 Aug 2026. This page uses it only to check the two inhaler-and-cartridge systems, labelled amount per actuation, their NDCs and 60 labelled actuations; it does not establish actual marketing, stock, purchase or individual operation.
DailyMed (NLM): current U.S. SPIRIVA RESPIMAT tiotropium bromide metered-inhalation-spray public label (Boehringer Ingelheim; SPL v16, published 19 Aug 2026) ↗
MARKET SCOPE
Market-record boundary
United States
Current public label and two exact package panels linkedThis page separately displays the 1.25 mcg and 2.5 mcg per-actuation cartons, each with one RESPIMAT inhaler plus its dedicated cartridge and 60 labelled actuations (NDC 0597-0160-61 and NDC 0597-0100-61). They do not authenticate a product or establish actual marketing, stock, purchase, individual use count, switching, device interchangeability or substitutability.
Mainland China, EU, Japan and other markets
Current market record not establishedNo local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, English brand, NDC, cartridge, cap colour or package image; every market requires separate review against current local regulatory material.
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
Both name tiotropium. Can SPIRIVA RESPIMAT and SPIRIVA HANDIHALER be self-switched by microgram number, device name or because both are inhalers?
No. RESPIMAT is a metered spray inhaler with a dedicated cartridge, while HANDIHALER is an inhalation-powder capsule with its dedicated device; a shared ingredient, brand family or microgram number does not establish a conversion or substitution. Take both actual packs, devices and the full medicine list to a pharmacist or prescribing team.
Do 1.25 mcg, 2.5 mcg or 60 labelled actuations on the carton mean someone can calculate or change their own use count?
No. These are the labelled per-actuation amount and package identity for this exact U.S.-labelled product. This page provides no personal use count, schedule, missed-use action, escalation, device steps or purchase advice; use the exact label in hand and check with a pharmacist or clinician.
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.