What this pack is
STALEVO is the brand name in this record; carbidopa, levodopa and entacapone is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
The current U.S. label explains that levodopa crosses the blood-brain barrier and is converted to dopamine in the brain; carbidopa inhibits peripheral levodopa decarboxylation, allowing more levodopa to reach the brain; and entacapone is a reversible, selective COMT inhibitor that affects another peripheral levodopa pathway. This mechanism explains why one tablet has three ingredients but cannot determine an individual's strength, frequency, switch or combination.
Read source: United States ↗Current regulatory record · reviewed 2026-08-27More about its action and precautions →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.
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
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
STALEVO is the brand name in this record; carbidopa, levodopa and entacapone is the generic name. Read both together with the dosage form (oral tablet).
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.
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
PRODUCT PRESENTATION 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.
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 public label (SPL v8, effective 27 Mar 2026; package panel marked Rev. 06/2021)
United States label · Current U.S. DailyMed public label (SPL v8, effective 27 Mar 2026; package panel marked Rev. 06/2021)
United States label · Current U.S. DailyMed public label (SPL v8, effective 27 Mar 2026; package panel marked Rev. 06/2021)
United States label · Current U.S. DailyMed public label (SPL v8, effective 27 Mar 2026; package panel marked Rev. 06/2021)
United States label · Current U.S. DailyMed public label (SPL v8, effective 27 Mar 2026; package panel marked Rev. 06/2021)
United States label · Current U.S. DailyMed public label (SPL v8, effective 27 Mar 2026; package panel marked Rev. 06/2021)
PUBLIC LABEL IMAGE
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
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.
STALEVO is a fixed three-ingredient combination, not a levodopa-only tablet. The current U.S. label says tablets must not be split, crushed or chewed and only one tablet is administered at each dosing interval. Every strength contains entacapone 200 mg; combining tablets or tablet portions to obtain more levodopa may cause entacapone overdose. The site does not turn this into an individual tablet count, schedule or conversion.
PHARMACOVIGILANCE · OFFICIAL ROUTES
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.
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 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.
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
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.
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 →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
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
Use this card to organise questions about STALEVO (carbidopa, levodopa and entacapone). Keep the exact pack, its current label and the full medicine list together.
STALEVO is the brand in this record and carbidopa, levodopa and entacapone is the active-ingredient name. Check both with the dosage form (STALEVO fixed three-ingredient film-coated oral tablets: six named strengths, 50, 75, 100, 125, 150 and 200; every tablet contains carbidopa and levodopa plus a fixed 200 mg of entacapone; all are listed as 100-tablet bottles in the U.S. label) and the market on the actual pack.
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.
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.
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 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.
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
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
SOURCE EVIDENCE REGISTER
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.
SOURCE-TRACEABLE ARCHIVE
This page includes an exact current U.S. public-label package panel for STALEVO, 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
The FDA administrative record links STALEVO, NDA 021485, an original NDA and the approval date 11 Jun 2003, initially covering STALEVO 50, 100 and 150. This U.S. node does not automatically establish another market's trade name, approval, supply, reference status or interchangeability.
FDA: STALEVO NDA 021485 administrative record and original-application approval date (11 Jun 2003) ↗The current U.S. public label lists six STALEVO strengths, six 100-tablet bottle NDCs, the whole-tablet boundary and the three-ingredient mechanism. The package panels themselves are marked Rev. 06/2021; the label effective date and package-panel version remain separate on this page.
DailyMed (NLM): current U.S. STALEVO public label (SPL v8, effective 27 Mar 2026) ↗MARKET SCOPE
This page separately records all three per-tablet ingredient amounts, NDC, 100-tablet bottle, LCE imprint and source for STALEVO 50, 75, 100, 125, 150 and 200. It supports product identity and safety reading; it does not authenticate a product or establish current stock, purchase, individual tablet count, interval, conversion, stopping or co-use.
No local trade name, approval, packaging, supply, sale eligibility, reference/originator relationship or interchangeability is inferred from the U.S. NDA, DailyMed name, NDC, three milligram values, LCE imprint or package image; every market requires separate review against current local regulatory material.
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.
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
No. 25/100/200 together identify carbidopa, levodopa and entacapone in the same tablet. The '100' in the name identifies only the levodopa component; the site does not split the three numbers into an individual dose or conversion formula.
Do not do this from a webpage. The current U.S. label says not to split, crush or chew and states that every strength contains entacapone 200 mg; combining tablets or tablet portions to obtain more levodopa may cause entacapone overdose. Have a pharmacist or prescriber review the actual pack, prescription and complete medicine list.
A webpage cannot decide this. Both may contain carbidopa/levodopa, while STALEVO additionally contains entacapone; shared ingredients create duplicate-ingredient and conversion risks. Have a pharmacist or prescriber review both actual products, the prescribed schedule and complete medicine list; do not self-stack, alternate, substitute or stop.
READ NEXT
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.