FDA-filed SPL labeling · retrieved through openFDA

Polyethylene Glycol 3350

Polyethylene Glycol 3350 is an osmotic laxative used across many over-the-counter products to relieve occasional constipation in adults and children 17 and older.

Brand names MiraLAXpurelaxGentleLaxHealthyLaxComfortlax +11 more
Drug class Osmotic Laxative
OTC Forms 3 Routes Oral · Topical
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 97 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveMay 4, 2026
Clinical labels in scope 97
AvailabilityOTC
Earliest approval/marketing year 1984
FDA-listed product records 240
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Polyethylene Glycol 3350 at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Polyethylene Glycol 3350 is a widely available over-the-counter powder that relieves occasional constipation by being dissolved in a drink and taken once daily. It typically works within 1 to 3 days and should not be used for more than a week without a doctor's input. People with kidney disease or those on prescription medications should check with a doctor or pharmacist before using it.

📖 Polyethylene Glycol 3350: Patient Information Guide

A plain-language walkthrough of Polyethylene Glycol 3350 — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Polyethylene Glycol 3350 is used across many over-the-counter products to relieve occasional constipation. Here's what the evidence supports:

  • Relieves occasional constipation (irregularity) — supported by MiraLAX, MiraLAX Orange Flavor, Dulcolax, Basic Care ClearLax, ClearLax, Clear Lax, berkley and jensen clearlax, careone clearlax, 365 WHOLE FOODS MARKET Polyethylene Glycol 3350, and numerous other store-brand formulations
  • Generally produces a bowel movement within 1 to 3 days — as noted across these same products
💊How it's taken

The powder is dissolved in 4 to 8 ounces of any beverage — cold, hot, or room temperature — stirred until no clumps remain, then drunk. It is taken once daily for adults and children 17 and older.

  • Use the bottle's measuring cap to get the right dose — do not eyeball it
  • Do not mix with starch-based thickeners used for swallowing problems
  • Do not use for more than 7 days in a row unless a doctor advises otherwise
  • Children 16 and under: ask a doctor before use
🤒Side effects — in detail

The most commonly reported effects while using Polyethylene Glycol 3350 include:

  • Loose, watery, or more frequent stools
  • Nausea
  • Bloating
  • Cramping
  • Abdominal pain
  • Diarrhea

Stop using it and call a doctor right away if you experience rectal bleeding, worsening pain or cramping, or diarrhea — these could point to a more serious problem.

⚠️Warnings & precautions
  • Kidney disease: Do not use Polyethylene Glycol 3350 if you have kidney disease unless a doctor is supervising your care.
  • Allergy: Do not use if you are allergic to polyethylene glycol.
  • Bowel changes: Ask a doctor before use if you have a sudden change in bowel habits lasting more than 2 weeks — this needs evaluation.
  • Irritable bowel syndrome (IBS): Check with a doctor before use.
  • Nausea, vomiting, or abdominal pain: Ask a doctor before starting.
  • Duration: Do not use for more than 7 days without a doctor's approval — long-term laxative use can signal an underlying issue.
  • Rectal bleeding or worsening symptoms: Stop use immediately and contact a doctor — these may be signs of a serious condition.
🔀What it interacts with

There are a few important things to watch for when using Polyethylene Glycol 3350 alongside other products or medications:

  • Starch-based thickeners (used to thicken liquids for people with swallowing difficulties): do not combine — the label specifically instructs against this
  • Prescription drugs: Ask a doctor or pharmacist before use if you take any prescription medication

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Do not use if you are allergic to polyethylene glycol
  • Do not use if you have kidney disease, unless a doctor is directly supervising you
  • Ask a doctor first if you have nausea, vomiting, or abdominal pain
  • Ask a doctor first if you have had a sudden change in bowel habits lasting more than 2 weeks
  • Ask a doctor first if you have irritable bowel syndrome (IBS)
  • Ask a doctor or pharmacist before use if you take any prescription medication
  • Pregnant or breastfeeding? Ask a health professional before use
  • Children 16 and under should not use this product without asking a doctor first
  • Keep all forms of this product out of reach of children
🚑If you take too much

If someone takes too much Polyethylene Glycol 3350, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Do not wait for symptoms to appear before calling.

📦How to store it

store at 20°-25°C (68°-77°F) • tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

📄 Written from Polyethylene Glycol 3350’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

17

Supplements & herbs that interact with Polyethylene Glycol 3350

17 supplements and herbal products have documented interactions with Polyethylene Glycol 3350 in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 7
  • Minor · 9
Every supplement checked against Polyethylene Glycol 3350 — ranked by severity The full interaction hub: 1 major · 7 moderate · 9 minor · every one linked to its full report. Check Polyethylene Glycol 3350 against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Polyethylene Glycol 3350 — the kind of thing our pharmacy team would talk through with you at the counter.

How long does it take for Polyethylene Glycol 3350 to work?
You can generally expect a bowel movement within 1 to 3 days after taking it. It's not meant to work in an hour like some other laxatives — it works gradually. If you haven't gone after a few days, check in with your doctor rather than doubling up on the dose.
Can I mix it into any drink, or does it have to be water?
You can stir it into any 4 to 8 ounces of beverage — water, juice, coffee, tea, whatever you like, cold or hot. The key is to stir it well until it's completely dissolved. Don't drink it if you still see clumps floating around.
Is it okay to use this for more than a week?
The label says to use it for no more than 7 days unless your doctor tells you otherwise. If you still need a laxative after a week, that's a signal to check with your doctor — ongoing constipation can sometimes point to something that needs attention.
Can I use this if I have kidney disease?
Not without your doctor's direct supervision. The label specifically warns against using Polyethylene Glycol 3350 if you have kidney disease unless a doctor is overseeing your care. Make sure to bring it up with your healthcare provider before starting.
What side effects should I actually worry about versus just expect?
It's pretty normal to have loose, watery, or more frequent stools — that's the laxative doing its job. What you don't want to ignore is rectal bleeding, worsening abdominal pain or cramping, or diarrhea that doesn't let up. If any of those happen, stop taking it and call your doctor right away.
Can I give this to my child?
The label says it's for adults and children 17 and older. For any child 16 or under, you need to ask a doctor before using it. Don't assume a smaller amount is safe — get proper guidance first.
Is Polyethylene Glycol 3350 available over the counter?
Yes — Polyethylene Glycol 3350 is available over the counter (without a prescription) in at least some forms, according to its FDA labeling. Follow the package directions and ask your pharmacist if you're unsure which product is right for you.
When was Polyethylene Glycol 3350 first available?
Polyethylene Glycol 3350 has been available in the United States since at least 1984, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Polyethylene Glycol 3350?
Polyethylene Glycol 3350 is supplied by 86 manufacturers listed in the FDA NDC Directory, including Bayer HealthCare LLC., Cardinal Health 107, LLC, Kroger Company.

💬 Answers drafted from Polyethylene Glycol 3350’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Polyethylene Glycol 3350 comes

Polyethylene Glycol 3350 is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Oral solution

By mouth
Brands Basic Care Clearlax Clearlax Clear Lax Gavilax Good Sense Clear Lax Kroger Laxative MiraLAX Mix-In Laxative Packets Purelax Smooth Lax
How this form is used
What it may be used for
  • Relieves occasional constipation (irregularity)
  • Generally produces a bowel movement within 1 to 3 days
Important instructions
  • Use the measuring cap to measure the correct dose; stir and dissolve completely in 4 to 8 ounces of any beverage before drinking
  • Take once a day; do not use for more than 7 days
  • Do not drink if there are any clumps in the beverage
  • Do not combine with starch-based thickeners; children 16 and under should ask a doctor first
Available strengths 2 strengths
221 FDA-listed product records

Oral powder

By mouth
Brands Dulcolax
How this form is used
What it may be used for
  • Dulcolax relieves occasional constipation (irregularity)
  • Dulcolax generally produces a bowel movement within 1 to 3 days
Important instructions
  • Dulcolax: use the measuring cap to fill to the indicated line for the correct dose
  • Dulcolax: stir and dissolve in 4 to 8 ounces of any beverage and drink once fully dissolved — no clumps
  • Dulcolax: take once a day and do not use for more than 7 days
  • Dulcolax: do not combine with starch-based thickeners; children 16 and under should ask a doctor first
Available strengths 1 strength
2 FDA-listed product records

Topical solution

On the skin
Available strengths 1 strength
1 FDA-listed product record

📊 Polyethylene Glycol 3350 across the U.S. market

How Polyethylene Glycol 3350 appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

3
Dose forms
86
Manufacturers
40
Brand names
240
FDA-listed product records
1984
First marketed

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (13) · Granule (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bayer HealthCare LLC.8%
Cardinal Health 107, LLC7%
Kroger Company5%
Strategic Sourcing Services Llc5%
Wal-Mart Stores Inc4%
Amazon.com Services LLC4%
Other makers68%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Polyethylene Glycol 3350 is used

A general measure of how commonly Polyethylene Glycol 3350 is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Polyethylene Glycol 3350 is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

3,441,581
Medicaid prescriptions filled (Q1–Q4 2025)
$60.5M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Polyethylene Glycol 3350 prescribed? Of the 1,596 medications we measure, Polyethylene Glycol 3350 ranks #59 by Medicaid prescriptions — more than 96% of them.

Where Polyethylene Glycol 3350 ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Polyethylene Glycol 3350 product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

polyethylene glycol 3350 17000 MG Powder for Oral Solution

3,421,730 Medicaid prescriptions (Q1–Q4 2025) 99% of Polyethylene Glycol 3350 prescriptions shown $59.6M gross reimbursement (before rebates) ≈ $17 per prescription (gross)

Summed across the 51 of 372 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 876193

Other Polyethylene Glycol 3350 products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

19,851 Medicaid prescriptions (Q1–Q4 2025) <1% of Polyethylene Glycol 3350 prescriptions shown $863,082 gross reimbursement (before rebates) ≈ $43 per prescription (gross)

Summed across the 3 of 46 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Polyethylene Glycol 3350, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 54 of 418 listed Polyethylene Glycol 3350 NDCs with Medicaid activity.

🔍 Compare Polyethylene Glycol 3350 products

A representative set of FDA-listed product records for Polyethylene Glycol 3350 — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 200 of 240 products — FDA National Drug Code Directory. See every product, package size and price: browse all 240 Polyethylene Glycol 3350 NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Polyethylene Glycol 3350 RxCUI 221147 1 dose form · 1 strength
  1. Dose form (SCDF) Powder for Oral Solution RxCUI 1870358 In current FDA listings
    Clinical drug / strength (SCD) 17000 MG RxCUI 876193

Look up RxCUI 221147 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

MiraLAX purelax GentleLax HealthyLax Comfortlax Dulcolax Osmotic Gavilax Clearlax clear lax Basic Care Clearlax Laxative Mix-In Laxative Packets Kroger Good Sense Clear Lax smooth lax gentle lax

🏭 Manufacturers & labelers

Bayer HealthCare LLC. 14 Cardinal Health 107, LLC 12 Kroger Company 9 Strategic Sourcing Services Llc 9 Wal-Mart Stores Inc 7 Amazon.com Services LLC 7 Walgreen Company 7 CVS Pharmacy 6 A-S Medication Solutions 6 Cardinal Health 5 Dow Benelux B.V. 5 L. Perrigo Company 5 Bryant Ranch Prepack 5 Atlantic Biologicals Corp. 5 H E B 4 Union Carbide Corporation, a subsidiary of The Dow Chemical Company 4 Safeway 4 Discount Drug Mart 4 Major Pharmaceuticals 4 Rite Aid Corporation 4 Target Corporation 3 Amerisource Bergen 3 ANI Pharmaceuticals, Inc. 3 Costco Wholesale Company 3

…and 16 more on the FDA NDC directory.

RxNorm drug class

Polyethylene Glycol 3350 belongs to the Osmotic Laxative class.

Pharmacologic class Osmotic Laxative
How it works Osmotic Activity

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective May 4, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Polyethylene Glycol 3350.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Polyethylene Glycol 3350 after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
97
NDC products indexed
240
Distinct labelers/manufacturers represented
86
Linked representative label
Bayer HealthCare LLC.
Linked label effective
May 4, 2026
Composite sections available
8
Linked SPL Set ID
d69ce3d4-7ca4-4fe3-b49e-6655e48d6963
Linked SPL Document ID
51040c1b-71bf-bb83-e063-6294a90aca4e
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 97 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Bayer HealthCare LLC. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.