What this pack is
AMITIZA is the brand name in this record; lubiprostone is the generic name. Read both together with the dosage form (oral capsule).
PACK CHECK · MARKET FIRST
AMITIZAGeneric namelubiprostone
How this medicine works
The current label describes lubiprostone as a locally acting chloride-channel activator that activates apical ClC-2 channels and increases chloride-rich intestinal fluid secretion. The mechanism helps explain the softening and transit boundary but cannot diagnose the cause of constipation or generate an individual regimen.
Read source: United States ↗Current regulatory record · reviewed 2026-08-30More 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
- AMITIZA
- Generic name
- lubiprostone
- Dosage-form class
- Lubiprostone oral soft gelatin capsules: 8 mcg and 24 mcg; swallow whole and do not break apart, cut, puncture, squeeze out, chew or visually estimate half
- Route
- Oral (whole soft gelatin capsule)
- 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.
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 · Current U.S. DailyMed brand label (SPL v4; effective 10 Jul 2026); exact pack identity, not real-time stock
Lubiprostone 8 mcg per capsule; 60-capsule bottle
- Product code
- NDC 23635-508-60
- Form and route
- AMITIZA lubiprostone oral soft gelatin capsule · oral (whole capsule)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-30; actual marketing, stock and availability are not established.
- lubiprostone
- 8 mcglabelled amount per capsule; not an individual's capsule count, frequency, duration or adjustment instruction
- Package
- 60 capsules per bottle
- Labelled appearance
- pink · oval soft gelatin capsule, about 9 mm; the capsule seam is not a dose-dividing score · imprint SPICapsule; not a scored tablet
United States label · Current U.S. DailyMed brand label (SPL v4; effective 10 Jul 2026); exact pack identity, not real-time stock
Lubiprostone 24 mcg per capsule; 60-capsule bottle
- Product code
- NDC 23635-524-60
- Form and route
- AMITIZA lubiprostone oral soft gelatin capsule · oral (whole capsule)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-30; actual marketing, stock and availability are not established.
- lubiprostone
- 24 mcglabelled amount per capsule; not an individual's capsule count, frequency, duration or adjustment instruction
- Package
- 60 capsules per bottle
- Labelled appearance
- orange · oval soft gelatin capsule, about 9 mm; the capsule seam is not a dose-dividing score · imprint SPICapsule; not a scored tablet
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
AMITIZA label reading: micrograms, whole softgel, diarrhoea and low blood pressure
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.
Check AMITIZA, lubiprostone, 8 or 24 mcg, pink/orange colour, SPI imprint and the exact NDC. Do not read micrograms as milligrams or mistake a 60-capsule bottle count for an amount to take.
- 8 mcg and 24 mcg are strengths per capsule; 1 mg equals 1,000 mcg as a unit relationship only. Do not self-change strength, capsule count or alternate products from colour, numbers or a previous pack.
- The current label says to swallow capsules whole and not break apart or chew. A softgel has no score for taking half; do not cut, puncture, squeeze out, measure or store part of its contents. For swallowing difficulty, first contact a pharmacist or prescribing team for an exact alternative route.
- The label says to take it with food and water and notes that food may reduce nausea. The site does not turn this into a personal timetable; contact the care team for persistent nausea, vomiting, inability to eat or drink, or worsening symptoms.
- The label says not to use it during severe diarrhoea and to contact a healthcare provider; diarrhoea or vomiting may occur with syncope and hypotension. Older people, those recently dehydrated or taking blood-pressure-lowering medicines should obtain prompt assessment for marked dizziness, unsteadiness or fainting; use local emergency care immediately for altered consciousness, severe breathlessness or another acute severe feature.
- Known or suspected mechanical gastrointestinal obstruction is a contraindication boundary, not ordinary constipation to treat by adding laxatives. Seek urgent care for progressively severe distension, repeated vomiting, severe abdominal pain, inability to pass stool or gas, or another acute warning feature.
- Put MiraLAX/polyethylene glycol, lactulose, bisacodyl, senna, magnesium laxatives, other prescription laxatives, blood-pressure medicines, opioids and supplements on one list. Do not self-combine, alternate or stop one; the label also notes that diphenylheptane opioids such as methadone may reduce lubiprostone's effect.
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 · 2026-08-30
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): current U.S. AMITIZA lubiprostone capsule brand label (SPL v4; effective 10 Jul 2026) ↗Current regulatory record · reviewed 2026-08-30
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 Orange Book: AMITIZA NDA 021908 24 mcg and 8 mcg both listed as prescription RLD products; 24 mcg also listed as the RS (data reviewed 30 Aug 2026) ↗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 AMITIZA (lubiprostone). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
AMITIZA is the brand in this record and lubiprostone is the active-ingredient name. Check both with the dosage form (Lubiprostone oral soft gelatin capsules: 8 mcg and 24 mcg; swallow whole and do not break apart, cut, puncture, squeeze out, chew or visually estimate half) 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. AMITIZA lubiprostone capsule brand label (SPL v4; effective 10 Jul 2026) ↗Current regulatory record · reviewed 2026-08-30
- FDA Orange Book: AMITIZA NDA 021908 24 mcg and 8 mcg both listed as prescription RLD products; 24 mcg also listed as the RS (data reviewed 30 Aug 2026) ↗reviewed 2026-08-29
HOW IT WORKS · NOT A TREATMENT PLAN
How lubiprostone works: local chloride-channel activation increases intestinal fluid
- AMITIZA is not the same medicine as LINZESS, MiraLAX, DULCOLAX, lactulose or senna. A shared constipation context does not justify combining, alternating or milligram/microgram conversion.
- A mechanism cannot rule out obstruction, bleeding, infection, metabolic disease or another cause. New or markedly changed bowel symptoms, especially with warning features, require professional assessment.
- When reviewing benefit and harm, record the actual pack, start date, changes in intake, other laxatives, opioids, blood-pressure medicines, diarrhoea, dizziness and falls—not only whether constipation improved.
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. AMITIZA lubiprostone capsule brand label (SPL v4; effective 10 Jul 2026) ↗Current regulatory record · reviewed 2026-08-30
- FDA Orange Book: AMITIZA NDA 021908 24 mcg and 8 mcg both listed as prescription RLD products; 24 mcg also listed as the RS (data reviewed 30 Aug 2026) ↗reviewed 2026-08-29
- FDA Drugs@FDA: AMITIZA NDA 021908 product and approval record ↗reviewed 2026-08-30
SOURCE-TRACEABLE ARCHIVE
AMITIZAlubiprostone
This page includes an exact current U.S. public-label package panel for AMITIZA, 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 approved AMITIZA 24 mcg
Current Orange Book product 001 records the 24 mcg prescription capsule as both RLD and RS.
FDA Orange Book: AMITIZA NDA 021908 24 mcg and 8 mcg both listed as prescription RLD products; 24 mcg also listed as the RS (data reviewed 30 Aug 2026) ↗FDA approved AMITIZA 8 mcg
Current Orange Book product 002 records the 8 mcg prescription capsule as RLD with RS marked No.
FDA Orange Book: AMITIZA NDA 021908 24 mcg and 8 mcg both listed as prescription RLD products; 24 mcg also listed as the RS (data reviewed 30 Aug 2026) ↗Current DailyMed label became effective
SPL v4 lists two exact NDCs, 60-capsule bottles, SPI imprint, whole-capsule rule and current safety information.
DailyMed (NLM): current U.S. AMITIZA lubiprostone capsule brand label (SPL v4; effective 10 Jul 2026) ↗
MARKET SCOPE
Market-record boundary
United States
Two prescription RLD strengths currently listed; two exact 60-capsule bottle panelsNDC 23635-508-60 is the 8 mcg pink softgel; NDC 23635-524-60 is the 24 mcg orange softgel. Regulatory listing and images do not establish live pharmacy stock, purchasing eligibility or individual suitability.
Mainland China and other markets
Current product record not establishedNo local approval, brand, supply, originator/reference relationship or interchangeability is inferred from a U.S. brand, NDA, softgel colour or microgram figure.
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 an AMITIZA softgel be cut and half taken?
No. The current label says to swallow it whole and not break apart or chew; do not puncture, squeeze out or estimate half. Ask a pharmacist or prescribing team to check an exact alternative route for swallowing difficulty.
Can I switch between 8 mcg and 24 mcg myself?
No. They are different strengths per capsule; the relevant use boundary and individual plan require a professional who knows the clinical context and current label. The site provides no conversion or capsule-count adjustment.
Can MiraLAX, lactulose or bisacodyl be used at the same time?
The site cannot make an individual co-use decision. Give the clinician or pharmacist every prescription medicine, OTC laxative, supplement, bowel record, diarrhoea and dizziness detail to review for duplication and dehydration.
What if an older person taking blood-pressure medicine develops diarrhoea and dizziness?
Contact the care team promptly. The label notes syncope and hypotension with diarrhoea or vomiting, and blood-pressure-lowering medicines may increase risk. Use local emergency care immediately for marked unsteadiness, fainting, altered consciousness or severe breathlessness.
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.