What this pack is
MiraLAX is the brand name in this record; polyethylene glycol 3350 is the generic name. Read both together with the dosage form (oral liquid).
PACK CHECK · MARKET FIRST
MiraLAXGeneric namepolyethylene glycol 3350
How this medicine works
The FDA historical review describes PEG 3350 as a poorly absorbed, osmotically active substance that retains water in intestinal contents and increases stool water. This explains an osmotic laxative, but cannot diagnose the cause of constipation, exclude obstruction or determine individual frequency and duration.
Read source: United States ↗Historical public 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
- MiraLAX
- Source-scoped market brand names
- MiraLAX · United StatesCurrent regulator record ↗FDA currently lists 17 g per marked-cap fill and 17 g per packet as RLD/RS OTC products; exact packs still require NDC and current-label checking.
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
- polyethylene glycol 3350
- Dosage-form class
- White polyethylene glycol 3350 powder for oral solution with no inactive ingredients; the bottle uses its original marked cap to identify 17 g, while each individual packet contains 17 g. Grams, milligrams, total bottle grams, a pack's stated number of uses and individual use are separate fields
- Route
- Oral after complete dissolution
- 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.
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 OTC label (SPL v24; effective 4 May 2026)
Polyethylene glycol 3350 17 g per packet; 10-packet carton
- Product code
- NDC 11523-7268-3
- Form and route
- MiraLAX polyethylene glycol 3350 powder-for-oral-solution packet · oral after complete dissolution (exact package-identity field)
- Container
- packet carton
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- polyethylene glycol 3350
- 17 glabelled amount per packet; 17 g equals 17,000 mg, but this is not an individual's frequency, course or increase instruction
- Package
- 10 packets per carton
- Labelled appearance
- white powder; colourless after dissolution · 17 g powder packet, not a tablet or capsule · imprint MiraLAX Mix-In Pax 10
United States label · Current U.S. DailyMed OTC label (SPL v24; effective 4 May 2026)
Polyethylene glycol 3350 17 g per packet; 20-packet carton
- Product code
- NDC 11523-7268-9
- Form and route
- MiraLAX polyethylene glycol 3350 powder-for-oral-solution packet · oral after complete dissolution (exact package-identity field)
- Container
- packet carton
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- polyethylene glycol 3350
- 17 glabelled amount per packet; 17 g equals 17,000 mg, but this is not an individual's frequency, course or increase instruction
- Package
- 20 packets per carton
- Labelled appearance
- white powder; colourless after dissolution · 17 g powder packet, not a tablet or capsule · imprint MiraLAX Mix-In Pax 20
United States label · Current U.S. DailyMed OTC label (SPL v24; effective 4 May 2026)
Polyethylene glycol 3350 17 g per fill to the original cap line; 510 g bottle; label describes about 30 marked-cap fills
- Product code
- NDC 11523-7234-4
- Form and route
- MiraLAX polyethylene glycol 3350 powder-for-oral-solution bottle · oral after measuring with the marked original cap and complete dissolution (exact package-identity field)
- Container
- bottle with marked measuring cap · 510 g
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- polyethylene glycol 3350
- 17 glabelled amount when filled to the original cap line; total bottle grams, pack dose count and individual use are different fields
- Package
- 1 bottle; 510 g total
- Labelled appearance
- white powder; colourless after dissolution · bottled powder with a marked cap, not a tablet, capsule or kitchen spoon · imprint MiraLAX 30 doses
United States label · Current U.S. DailyMed OTC label (SPL v24; effective 4 May 2026)
Polyethylene glycol 3350 17 g per fill to the original cap line; two bottles, 578 g each; label describes about 34 marked-cap fills
- Product code
- NDC 11523-4357-3
- Form and route
- MiraLAX polyethylene glycol 3350 powder-for-oral-solution bottle · oral after measuring with the marked original cap and complete dissolution (exact package-identity field)
- Container
- twin-bottle pack · 578 g
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- polyethylene glycol 3350
- 17 glabelled amount when filled to the original cap line; total bottle grams, pack dose count and individual use are different fields
- Package
- 2 × bottles per pack; 578 g each
- Labelled appearance
- white powder; colourless after dissolution · bottled powder with a marked cap, not a tablet, capsule or kitchen spoon · imprint MiraLAX 34 doses
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
MiraLAX label reading: separate 17 g, 17,000 mg, per packet, the cap line and total bottle contents
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 current U.S. OTC label separately states 17 g per packet and 17 g when the original bottle cap is filled to its line. The site enlarges units, package identity, complete dissolution and warnings; it does not decide individual use, frequency, duration or paediatric use.
- One gram equals 1,000 milligrams, so 17 g equals 17,000 mg. This is only a unit conversion; it does not make another powder, spoon or medicine self-substitutable at 17,000 mg, or determine anyone's frequency or duration.
- Each packet contains 17 g; the bottle uses its supplied cap with the marked white line. A kitchen spoon, another medicine's cap, visual powder splitting or an unvalidated scale is not the same labelled product measure.
- The label says to stir until fully dissolved and not drink while clumps remain; it also says not to combine with starch-based thickeners used for swallowing difficulty. A person with dysphagia needs a pharmacist or clinical team to review the specific safe plan.
- Kidney disease, nausea, vomiting, abdominal pain, a sudden bowel-habit change lasting over two weeks, irritable bowel syndrome, or taking a prescription medicine are label reasons to ask a doctor or pharmacist first. The site cannot decide individual suitability from age or symptoms.
- Rectal bleeding, worsening abdominal pain, bloating or cramping, diarrhoea, or needing a laxative beyond one week are reasons not to self-extend use and to seek professional assessment. Severe pain, persistent vomiting, marked distension, inability to pass gas or stool, fainting or severe dehydration may require emergency care.
- PEG-electrolyte bowel preparations, orange-flavour products, MiraFAST, MiraSOFT, other Mira-family products and other PEG 3350 brands are not the four exact packs in this dossier. Do not self-substitute from ‘polyethylene glycol’ or purple packaging alone.
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
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. MiraLAX polyethylene glycol 3350 OTC label (SPL v24; effective 4 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 MiraLAX NDA 022015 products, RLD status and approval history ↗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 MiraLAX (polyethylene glycol 3350). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
MiraLAX is the brand in this record and polyethylene glycol 3350 is the active-ingredient name. Check both with the dosage form (White polyethylene glycol 3350 powder for oral solution with no inactive ingredients; the bottle uses its original marked cap to identify 17 g, while each individual packet contains 17 g. Grams, milligrams, total bottle grams, a pack's stated number of uses and individual use are separate fields) 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 the exact dosage form
Verify the exact dosage form and current label before altering, transferring or substituting any product. A similar name or 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. MiraLAX polyethylene glycol 3350 OTC label (SPL v24; effective 4 May 2026) ↗Current regulatory record · reviewed 2026-08-29
- FDA Drugs@FDA: current MiraLAX NDA 022015 products, RLD status and approval history ↗reviewed 2026-08-29
HOW IT WORKS · NOT A TREATMENT PLAN
How polyethylene glycol 3350 works: osmotic water retention does not make every constipation problem suitable for self-care
- Bed rest, dehydration, diet change, reduced activity, illness and many medicines can contribute to constipation. An older person using opioids, anticholinergics, iron, calcium or other medicines should have the complete list reviewed rather than simply adding laxatives.
- ‘Osmotic’ does not permit self-combination, alternation or gram conversion with bisacodyl, senna, lactulose, magnesium salts or another constipation product. Ingredients, onset, warnings and renal boundaries differ.
- If impaction, obstruction, severe dehydration or an adverse drug effect is suspected, a mechanism cannot replace examination. Persistent or severe symptoms need local medical care and emergency help when serious.
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. MiraLAX polyethylene glycol 3350 OTC label (SPL v24; effective 4 May 2026) ↗Current regulatory record · reviewed 2026-08-29
- FDA Drugs@FDA: current MiraLAX NDA 022015 products, RLD status and approval history ↗reviewed 2026-08-29
- FDA: MiraLAX NDA 022015 Rx-to-OTC review material (2006; historical pharmacology and product background) ↗Historical public record · reviewed 2026-08-29
SOURCE-TRACEABLE ARCHIVE
MiraLAXpolyethylene glycol 3350
This page includes an exact current U.S. public-label package panel for MiraLAX, 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
Prescription MiraLAX U.S. approval history
The FDA 2006 review records approval of prescription MiraLAX NDA 020698 on 18 Feb 1999. This historical point does not establish current prescription status or packaging.
FDA: MiraLAX NDA 022015 Rx-to-OTC review material (2006; historical pharmacology and product background) ↗NDA 022015 Rx-to-OTC switch approved
Drugs@FDA lists a Type 8 partial Rx-to-OTC switch approval on this date and records MiraLAX 17 g per marked-cap fill and 17 g per packet products.
FDA Drugs@FDA: current MiraLAX NDA 022015 products, RLD status and approval history ↗Current DailyMed SPL v24 effective
The current Bayer label lists Drug Facts, cap and packet directions, package NDCs, warnings and official panels. The date identifies the label version, not an individual's start date.
DailyMed (NLM): current U.S. MiraLAX polyethylene glycol 3350 OTC label (SPL v24; effective 4 May 2026) ↗
MARKET SCOPE
Market-record boundary
United States
Current OTC RLD/RS; four exact displayed package identities establishedThe page records 17 g per packet, 17 g per marked cap, pack count, total bottle grams and NDC. These fields do not establish local stock, individual suitability or automatic substitution with another PEG product.
Mainland China and other markets
Current market record not establishedNo local approval, trade name, pack, supply, originator/generic relationship or interchangeability is inferred from the U.S. MiraLAX name, PEG 3350 ingredient or pack colour.
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 17 g the same as 17 mg, and what does 510 g on a bottle mean?
No. 17 g equals 17,000 mg and is the labelled amount per packet or per fill to the original cap line; 510 g is the bottle's total net powder content. Neither unit conversion nor total pack content determines individual frequency or duration.
Can a kitchen spoon or visual half be used if the original cap is missing?
Do not assume equivalence. The current label verifies only the marked original cap and individual 17 g packets. Take the product and pack to a pharmacist to confirm an appropriate measure or product; the site does not calculate grams from spoon appearance.
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.