What this pack is
LINZESS is the brand name in this record; linaclotide is the generic name. Read both together with the dosage form (oral capsule).
PACK CHECK · MARKET FIRST
LINZESSGeneric namelinaclotide
How this medicine works
The U.S. label describes linaclotide as a guanylate cyclase-C (GC-C) agonist acting locally on the luminal surface of intestinal epithelium, increasing cGMP and promoting chloride, bicarbonate and intestinal-fluid secretion with faster transit. This explains an action pathway but cannot diagnose constipation, exclude obstruction or choose a strength for an older person.
Read source: United States ↗Current regulatory record · reviewed 2026-08-29More 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
- LINZESS
- Source-scoped market brand names
- LINZESS · United StatesCurrent regulator record ↗NDA 202811; 72, 145 and 290 mcg capsules are prescription RLD products, with 72 and 145 mcg also listed as RS; the current SPL provides three 30-capsule bottle panels.
- Linzess Tablets 0.25 mg · JapanCurrent regulator record ↗The current PMDA record is a linaclotide 0.25 mg film-coated tablet; it is not a U.S. capsule identity.
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
- linaclotide
- Dosage-form class
- United States: linaclotide 72, 145 and 290 mcg oral capsules. Japan: linaclotide 0.25 mg film-coated oral tablet. The U.S. label permits opening a capsule through specified swallowing-difficulty routes and using the complete contents of one capsule, but not chewing, crushing, visual halving or storing a mixture.
- Route
- Oral (cross-market exact-product identity field)
- 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
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.
4 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 · Current U.S. DailyMed brand label (SPL v39; effective 21 May 2026)
Linaclotide 72 mcg per capsule; 30-capsule bottle
- Product code
- NDC 0456-1203-30
- Form and route
- LINZESS linaclotide oral capsule · oral (whole capsule or the label-specified complete-contents route)
- Container
- 30-capsule prescription bottle label panel
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- linaclotide
- 72 mcglabelled amount per capsule; not an individual's capsule count, frequency, duration or adjustment instruction
- Package
- 30 capsules per bottle
- Labelled appearance
- white to off-white opaque · hard gelatin capsule; unscored; do not chew or crush · imprint FL 72Unscored; the cited label requires the complete contents
United States label · Current U.S. DailyMed brand label (SPL v39; effective 21 May 2026)
Linaclotide 145 mcg per capsule; 30-capsule bottle
- Product code
- NDC 0456-1201-30
- Form and route
- LINZESS linaclotide oral capsule · oral (whole capsule or the label-specified complete-contents route)
- Container
- 30-capsule prescription bottle label panel
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- linaclotide
- 145 mcglabelled amount per capsule; not an individual's capsule count, frequency, duration or adjustment instruction
- Package
- 30 capsules per bottle
- Labelled appearance
- white to off-white opaque · hard gelatin capsule; unscored; do not chew or crush · imprint FL 145Unscored; the cited label requires the complete contents
United States label · Current U.S. DailyMed brand label (SPL v39; effective 21 May 2026)
Linaclotide 290 mcg per capsule; 30-capsule bottle
- Product code
- NDC 0456-1202-30
- Form and route
- LINZESS linaclotide oral capsule · oral (whole capsule or the label-specified complete-contents route)
- Container
- 30-capsule prescription bottle label panel
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- linaclotide
- 290 mcglabelled amount per capsule; not an individual's capsule count, frequency, duration or adjustment instruction
- Package
- 30 capsules per bottle
- Labelled appearance
- white to off-white opaque · hard gelatin capsule; unscored; do not chew or crush · imprint FL 290Unscored; the cited label requires the complete contents
JP · Current Japan PMDA product page (electronic-label route dated 27 Aug 2026)
Linaclotide 0.25 mg per tablet; Japanese film-coated tablet
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
- PMDA 2399017F1020
- Form and route
- Linzess linaclotide 0.25 mg film-coated oral tablet · oral (Japanese tablet product-identity field)
- Container
- exact public package image not established in this review
- Listing review
- Cited public label display reviewed 2026-08-29; actual marketing, stock and availability are not established.
- linaclotide
- 0.25 mglabelled amount per tablet; 0.25 mg equals 250 mcg as unit conversion only, not as a basis for interchange with a U.S. capsule
- Package
- Package quantity requires source review
- Labelled appearance
- check the current Japanese electronic label · film-coated tablet, not a U.S. capsule · imprint not asserted
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
LINZESS label reading: mcg is not a capsule count, and opening does not mean dividing
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.
The U.S. label first states to swallow the capsule whole. For swallowing difficulty, it describes opening the capsule and using the complete contents of one capsule through specified applesauce or water routes. Do not chew, crush, visually divide or store a mixture for later. The site explains label boundaries but does not choose an individual strength, frequency or duration.
- 72, 145 and 290 mcg are labelled amounts per capsule, while 30 is the bottle count. A microgram (mcg) is not a milligram (mg): 1 mg equals 1,000 mcg. Unit conversion cannot decide an individual's capsule count, strength change or make-up use.
- The label does not permit ‘pouring out half’. If the capsule is opened through the swallowing-difficulty route, the complete contents of one capsule are used and administered immediately as specified. Do not chew or crush the beads or split them visually into portions.
- Severe diarrhoea can cause dehydration. Marked thirst, reduced urination, dizziness, weakness, fainting or mental-status change needs prompt professional help, particularly in an older person, child or someone also using a diuretic; use local emergency services when severe.
- Known or suspected mechanical gastrointestinal obstruction is a U.S. label contraindication. Persistent severe pain, marked distension, repeated vomiting or inability to pass gas or stool must not be treated as ordinary constipation by simply adding more medicine.
- The U.S. label has a boxed warning for serious dehydration and a contraindication in children under 2 years. The site does not generate paediatric use from age, weight or symptoms; current local labelling and the treating professional are required.
- MiraLAX, lactulose, bisacodyl, senna, magnesium salts, other prescription constipation medicines and bowel-cleansing products are not one product. A shared bowel-related use does not permit self-combination, alternation, time-separation or stopping. Older adults should review prescriptions, OTC products, supplements and actual bowel changes together.
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 · 2026-08-29
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
- Japan · 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. LINZESS linaclotide capsule brand label (SPL v39; effective 21 May 2026) ↗Current regulatory record · reviewed 2026-08-29
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.
- FDA · United States · Regulatory product record or label archive · 2026-08-29FDA Drugs@FDA: current LINZESS NDA 202811 application, RLD and RS records ↗reviewed 2026-08-29
- PMDA · Japan · Regulatory product record · 2026-08-29Japan PMDA: current Linzess 0.25 mg tablet product, electronic-label and patient-information routes (27 Aug 2026) ↗Current regulatory record · reviewed 2026-08-29
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 LINZESS (linaclotide). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
LINZESS is the brand in this record and linaclotide is the active-ingredient name. Check both with the dosage form (United States: linaclotide 72, 145 and 290 mcg oral capsules. Japan: linaclotide 0.25 mg film-coated oral tablet. The U.S. label permits opening a capsule through specified swallowing-difficulty routes and using the complete contents of one capsule, but not chewing, crushing, visual halving or storing a mixture.) 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.
- DailyMed (NLM): current U.S. LINZESS linaclotide capsule brand label (SPL v39; effective 21 May 2026) ↗Current regulatory record · reviewed 2026-08-29
- FDA Drugs@FDA: current LINZESS NDA 202811 application, RLD and RS records ↗reviewed 2026-08-29
- Japan PMDA: current Linzess 0.25 mg tablet product, electronic-label and patient-information routes (27 Aug 2026) ↗Current regulatory record · reviewed 2026-08-29
HOW IT WORKS · NOT A TREATMENT PLAN
How linaclotide works: luminal GC-C activation does not make all constipation the same
- Linaclotide works differently from polyethylene glycol 3350, lactulose, stimulant laxatives or stool softeners. ‘All constipation medicines’ does not permit self-conversion by micrograms, milligrams, grams or perceived speed.
- U.S. 72/145/290 mcg capsules and the Japanese 0.25 mg tablet share an ingredient but differ in dosage form, strength, labelled indications and administration instructions. The arithmetic fact that 0.25 mg equals 250 mcg does not establish interchangeability.
- Whole-genome screening is not a universal prerequisite set by this site for constipation-medicine choice. Review more directly needs the exact symptoms and diagnosis, obstruction warnings, age, dehydration and fall risk, kidney and cardiovascular context, all medicines and prior responses.
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. LINZESS linaclotide capsule brand label (SPL v39; effective 21 May 2026) ↗Current regulatory record · reviewed 2026-08-29
- FDA Drugs@FDA: current LINZESS NDA 202811 application, RLD and RS records ↗reviewed 2026-08-29
- FDA: LINZESS NDA 202811/S-022 supplemental approval letter (2026) ↗Current regulatory record · reviewed 2026-08-29
- FDA: LINZESS NDA 202811 original-application public review material (2012) ↗reviewed 2026-08-29
- Japan PMDA: current Linzess 0.25 mg tablet product, electronic-label and patient-information routes (27 Aug 2026) ↗Current regulatory record · reviewed 2026-08-29
SOURCE-TRACEABLE ARCHIVE
LINZESSlinaclotide
This page includes an exact current U.S. public-label package panel for LINZESS, 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
FDA initially approved LINZESS
FDA public records link 145 and 290 mcg capsules to NDA 202811. The date does not indicate that any current individual should use a strength.
FDA: LINZESS NDA 202811 original-application public review material (2012) ↗U.S. 72 mcg product approval node
The current Orange Book lists 72 mcg as product 003, RLD and RS.
FDA Drugs@FDA: current LINZESS NDA 202811 application, RLD and RS records ↗Current DailyMed SPL v39 effective
The current label provides three capsules, three 30-capsule bottle panels, swallowing-difficulty routes, boxed warning, diarrhoea and mechanism information.
DailyMed (NLM): current U.S. LINZESS linaclotide capsule brand label (SPL v39; effective 21 May 2026) ↗Japan PMDA product-information update route
The current PMDA page lists Linzess 0.25 mg tablets, electronic labelling and patient information; the Japanese tablet is kept separate from U.S. capsules.
Japan PMDA: current Linzess 0.25 mg tablet product, electronic-label and patient-information routes (27 Aug 2026) ↗
MARKET SCOPE
Market-record boundary
United States
Current prescription RLD capsules; 72 and 145 mcg are RSThree 30-capsule bottle panels are recorded individually. Regulatory and package records do not establish real-time stock, purchasing eligibility, individual suitability or interchangeability.
Japan
Current PMDA 0.25 mg film-coated tablet recordThis review establishes a source-text identity and official electronic-label route without showing an unverified package image; the U.S. capsule must not be used to infer the Japanese tablet.
Mainland China, EU and other markets
Current market records not establishedNo local approval, dosage form, pack, supply, originator/generic relationship or interchangeability is inferred from U.S. or Japanese names, a shared ingredient or unit conversion.
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
Can a 145 mcg capsule be opened and half used as a smaller strength?
Do not do this yourself. The U.S. label permits opening only as a swallowing-difficulty administration route and uses the complete contents of one capsule without chewing or crushing. It does not describe visually dividing beads as dose reduction. Any adjustment requires review of the exact prescription and available product.
Does Japanese 0.25 mg equal 250 mcg and permit switching to a U.S. 145 or 290 mcg capsule?
0.25 mg equals 250 mcg as unit conversion only. The Japanese product is a tablet and the U.S. products are capsules, with different strengths, labelled indications, administration instructions and regulatory identities. This does not permit self-switching, capsule assembly or cross-border substitution.
Can LINZESS be added to another constipation medicine?
The site cannot decide from purpose alone. Multiple bowel medicines may compound diarrhoea, dehydration, electrolyte or fall risk, and an older person may also use diuretics, blood-pressure medicines or medicines affecting gut motility. Have all prescriptions, OTC products and actual symptoms reviewed.
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.