PEG-3350 and Electrolytes Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride 3350 236 g/4L; 22.74 g/4L; 6.74 g/4L; 5.86 g/4L; 2.97 g/4L Powder, For Solution, 4 l — NDC 10572-0100-01 package photo

PEG-3350 and Electrolytes Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride 3350 236 g/4L; 22.74 g/4L; 6.74 g/4L; 5.86 g/4L; 2.97 g/4L Powder, For Solution, 4 l

by Affordable Pharmaceuticals, LLC · 4 L in 1 JUG (10572-100-01)
NDC 10572-0100-01
🏷️ FDA NDC (as labeled) 10572-100-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 10, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 10572-100-01
Product NDC 10572-100
11-digit billing NDC 10572010001
NCPDP billing unit ML — per mL (volume)
RxCUI 966920
UNII G2M7P15E5P, 36KCS0R750, 8MDF5V39QO, 451W47IQ8X, 660YQ98I10
Application # NDA019011
SPL Set ID 448db7a5-1fea-4bf3-b1f5-e9d027a36603
Established class (EPC) Osmotic Laxative
Mechanism of action Osmotic Activity
Physiologic effect Stimulation Large Intestine Fluid/Electrolyte Secretion
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-07-01
Route ORAL
Dosage form POWDER, FOR SOLUTION
Substance POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE
GPI-14 46992005302130
GPI class PEG-3350/Electrolytes
GCN Seq No 062533
GCN 98308
HICL code 034667
Ingredient (HICL) Peg3350/Sod Sulf,Bicarb,Cl/Kcl
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Colon
HIC3 code D6S
Therapeutic class — specific (HIC3) Laxatives And Cathartics
AHFS code 56:12.00.00
AHFS class Cathartics And Laxatives
FDB label name PEG-3350 AND ELECTROLYTES SOLN
FDB brand name Peg-3350 And Electrolytes
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 10572-100-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 10572-0100-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Osmotic Laxative class.

Pharmacologic class Osmotic Laxative
How it works Osmotic Activity
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAffordable Pharmaceuticals, LLC
Application holderAZURITY PHARMACEUTICALS INC
FDA applicationNDA019011 (NDA AUTHORIZED GENERIC)
Labeler code10572
First marketedJul 2009
Product typeHuman Prescription Drug
Portfolio4 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name PEG-3350 AND ELECTROLYTES SOLN Ingredient Peg3350/Sod Sulf,Bicarb,Cl/Kcl
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

FlavorPineapple
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.005
Medicaid paysCMS SDUD · 12 mo $0.0054
Medicare drug plans payPart D · Q2 2026 $0.0081
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.005 $0.003
▲ Up 59% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
PEG-3350 and Electrolytes 3350 236 g/4L; 22.74 g/4L; 6.74 g/4L; 5.86 g/4L; 2.97 g/4Lthis 10572-0100-01 Affordable 4 l $0.005 AA Availability likely
Gavilyte G Tm 3350 236 g/274.31g; 22.74 g/274.31g; 6.74 g/274.31g; 5.86 g/274.31g; 2.97 g/274.31g 43386-0090-19 Lupin 274.31 g $0.005 AA Availability likely
PEG 3350 and Electrolytes 3350 236 g/4L; 22.74 g/4L; 6.74 g/4L; 5.86 g/4L; 2.97 g/4L 52536-0236-01 Wilshire 4 l $0.005 AA Availability likely
Polyethylene Glycol 3350 and electrolytes with Lemon Flavor 3350 236 g/4L; 22.74 g/4L; 6.74 g/4L; 5.86 g/4L; 2.97 g/4L 64380-0766-21 Strides 4 l $0.005 AA Availability likely
GoLYTELY 3350 236 g/4L; 22.74 g/4L; 6.74 g/4L; 5.86 g/4L; 2.97 g/4L 24338-0236-01 Azurity 4 l $0.006 AA Availability likely +29%
GoLYTELY 3350 236 g/4L; 22.74 g/4L; 6.74 g/4L; 5.86 g/4L; 2.97 g/4L 52268-0100-01 Braintree 4 l $0.006 AA Availability likely +29%
Polyethylene Glycol-3350 And Electrolytes 3350 236 g/274.31g; 22.74 g/274.31g; 6.74 g/274.31g; 5.86 g/274.31g; 2.97 g/274.31g 40032-0090-19 Novel 274.31 g AA FDA listed
PEG-3350 and Electrolytes 3350 236 g/4L; 22.74 g/4L; 6.74 g/4L; 5.86 g/4L; 2.97 g/4L 50090-6521-00 A-S 4 l AA FDA listed
Polyethylene Glycol 3350 and electrolytes - Unflavored 3350 236 g/4L; 22.74 g/4L; 6.74 g/4L; 5.86 g/4L; 2.97 g/4L 64380-0765-21 Strides 4 l AA FDA listed
Polyethylene Glycol 3350 and electrolyteswith Orange Flavor 3350 236 g/4L; 22.74 g/4L; 6.74 g/4L; 5.86 g/4L; 2.97 g/4L 64380-0767-21 Strides 4 l AA FDA listed
PEG 3350 and Electrolytes 3350 236 g/4L; 22.74 g/4L; 6.74 g/4L; 5.86 g/4L; 2.97 g/4L 50090-8020-00 A-S 4 l AA FDA listed
About this product: this is an authorized generic — the brand-name product marketed without its brand name. Other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2009
On the market since
Jul 2009
📍
2026
Currently FDA-listed
17 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 10572-0100-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
109.4K
Units reimbursed last 4 qtrs
445.6M
Gross reimbursed last 4 qtrs
$2.39M
Avg / prescription
$21.85
Avg / unit
$0.0054
Latest quarter Q4 2025
26.7KRx
Medicaid pays / mL
$0.0054
gross reimbursed
vs
NADAC / mL
$0.0046
acquisition cost
=
Spread
+$0.0008
+17% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
44% FFS 56% MCO
Fee-for-service · 47,870 Rx Managed care · 61,522 Rx
State Medicaid map
Alaska: 4,028,000 units · 549,523 per 100k residents AK Maine: 1,440,000 units · 103,226 per 100k residents ME Washington: 35,188,005 units · 450,435 per 100k residents WA Idaho: 2,464,000 units · 125,458 per 100k residents ID Montana: 2,620,002 units · 231,449 per 100k residents MT North Dakota: 1,040,000 units · 132,822 per 100k residents ND Minnesota: 7,489,001 units · 130,539 per 100k residents MN Wisconsin: 11,619,600 units · 196,609 per 100k residents WI Michigan: 14,709,000 units · 146,548 per 100k residents MI New York: 31,153,950 units · 159,184 per 100k residents NY Vermont: 864,000 units · 133,539 per 100k residents VT New Hampshire: 1,048,002 units · 74,750 per 100k residents NH Oregon: 13,474,000 units · 318,309 per 100k residents OR Nevada: 6,924,000 units · 216,781 per 100k residents NV Wyoming: 132,000 units · 22,603 per 100k residents WY South Dakota: 1,208,000 units · 131,447 per 100k residents SD Iowa: 1,716,000 units · 53,508 per 100k residents IA Illinois: 16,948,000 units · 135,055 per 100k residents IL Indiana: 7,920,001 units · 115,418 per 100k residents IN Ohio: 13,788,000 units · 116,996 per 100k residents OH Pennsylvania: 10,506,400 units · 81,062 per 100k residents PA New Jersey: 8,164,261 units · 87,882 per 100k residents NJ Massachusetts: 5,824,029 units · 83,189 per 100k residents MA California: 84,761,550 units · 217,533 per 100k residents CA Utah: 2,092,000 units · 61,223 per 100k residents UT Colorado: 5,948,000 units · 101,191 per 100k residents CO Nebraska: 2,964,000 units · 149,848 per 100k residents NE Missouri: 11,504,000 units · 185,668 per 100k residents MO Kentucky: 9,308,008 units · 205,656 per 100k residents KY West Virginia: 4,644,000 units · 262,373 per 100k residents WV Virginia: 13,184,000 units · 151,262 per 100k residents VA Maryland: 8,741,003 units · 141,440 per 100k residents MD Connecticut: 2,836,000 units · 78,408 per 100k residents CT Rhode Island: 496,000 units · 45,297 per 100k residents RI Arizona: 16,136,401 units · 217,150 per 100k residents AZ New Mexico: 11,916,000 units · 563,671 per 100k residents NM Kansas: 884,000 units · 30,068 per 100k residents KS Arkansas: 4,168,000 units · 135,898 per 100k residents AR Tennessee: 4,156,000 units · 58,322 per 100k residents TN North Carolina: 6,920,000 units · 63,867 per 100k residents NC South Carolina: 3,153,000 units · 58,682 per 100k residents SC Delaware: 408,000 units · 39,573 per 100k residents DE Oklahoma: 12,568,001 units · 310,091 per 100k residents OK Louisiana: 6,544,401 units · 143,078 per 100k residents LA Mississippi: 1,724,000 units · 58,639 per 100k residents MS Alabama: 1,732,000 units · 33,908 per 100k residents AL Georgia: 4,816,001 units · 43,667 per 100k residents GA D.C.: 2,288,402 units · 337,025 per 100k residents DC Hawaii: 1,136,000 units · 79,164 per 100k residents HI Texas: 8,262,001 units · 27,086 per 100k residents TX Florida: 10,148,910 units · 44,887 per 100k residents FL
Units reimbursed · per 100k residents
22,603563,671
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New Mexico 563,671 /100k
2 Alaska 549,523 /100k
3 Washington 450,435 /100k
4 D.C. 337,025 /100k
5 Oregon 318,309 /100k
6 Oklahoma 310,091 /100k
7 West Virginia 262,373 /100k
8 Montana 231,449 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for PEG-3350 And Electrolytes — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name PEG-3350 And Electrolytes. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.84M
Claims incl. refills
116K
Beneficiaries
112.3K
Spend / beneficiary
$16.42
Spend / claim
$15.90
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for PEG-3350 and Electrolytes (this brand).

Top reported reactions

Vomiting45
Nausea44
Abdominal Distension32
Abdominal Pain26
Diarrhoea20
Fatigue18
Pain18

Age at onset

Adolescent1
Adult45
Elderly23

Reporter sex

297 reports
Male · 40%
Female · 60%
Unknown · 0%

Serious outcomes

Hospitalization50
Death8
Life-threatening6
Disabling5
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 42 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
10572-0100-01 You're viewing this 4 L in 1 JUG (10572-100-01) 2009-07-01 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 62 words

1 INDICATIONS AND USAGE PEG-3350 and Electrolytes for Oral Solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults. PEG-3350 and Electrolytes for Oral Solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults ( 1 )

⏱️ Dosage and Administration ~3 min read

2 DOSAGE AND ADMINISTRATION Preparation and Administration ( 2.1 ): Correct fluid and electrolyte abnormalities before treatment with PEG-3350 and Electrolytes for Oral Solution. Reconstitute PEG-3350 and Electrolytes for Oral Solution with water prior to ingestion. Do not take oral medications within 1 hour before the start or during administration of PEG-3350 and Electrolytes for Oral Solution.

( 2.1 ) Do not take other laxatives while taking PEG-3350 and Electrolytes for Oral Solution. Consume only clear liquids; avoid red and purple liquids. Consume water or other clear liquids up until 2 hours before the time of the colonoscopy.

Do not consume solid food within 2 hours before starting PEG-3350 and Electrolytes for Oral Solution. Adult Dosing Regimen ( 2.2 ): On day prior to colonoscopy, instruct patients to consume a light breakfast at least 2 hours before starting PEG-3350 and Electrolytes for Oral Solution. Begin the recommended dosage regimen for PEG-3350 and Electrolytes for Oral Solution early in the evening on the day before colonoscopy.

Drink reconstituted solution at a rate of 8 ounces every 10 minutes, until 4 liters are consumed, or rectal effluent is clear. For complete information on dosing, preparation and administration, see the full prescribing information. ( 2.1 , 2.2 )

2.1Important Preparation and Administration Instructions Correct fluid and electrolyte abnormalities before treatment with PEG-3350 and Electrolytes for Oral Solution [see Warnings and Precautions (5.1)] . Reconstitute PEG-3350 and Electrolytes for Oral Solution with water prior to ingestion, do not take undissolved PEG-3350 and Electrolytes for Oral Solution [see Dosage and Administration (2.2)] . Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions (5.7)] .

Do not take oral medications within 1 hour before the start of or during administration of PEG-3350 and Electrolytes for Oral Solution [see Drug Interactions (7.2)] . Do not take other laxatives while taking PEG-3350 and Electrolytes for Oral Solution [see Drug Interactions (7.3)] . Consume only clear liquids, avoid red and purple liquids.

Patients may consume water or other clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy. The solution is more palatable if chilled prior to administration. Do not consume solid food within 2 hours before starting PEG-3350 and Electrolytes for Oral Solution.

For the best results, do not consume solid food for 3 to 4 hours before drinking the solution. If severe bloating, distention or abdominal pain occurs, slow or temporarily discontinue PEG-3350 and Electrolytes for Oral Solution until the symptoms abate.

2.2Dosage Regimen Instruct adult patients that on the day before the colonoscopy procedure, they may consume a light breakfast at least 2 hours before starting PEG-3350 and Electrolytes for Oral Solution. Begin the recommended dosage regiment for PEG-3350 and Electrolytes for Oral Solution early in the evening on the day before colonoscopy. Instruct patients to take PEG-3350 and Electrolytes for Oral Solution in conjunction with clear liquids as follows: 4 Liter Jug Fill the supplied container containing the PEG-3350 and Electrolytes for Oral Solution powder with lukewarm drinking water to the 4-liter fill line • Do not add any other ingredients, flavors, etc.

After capping the container, shake vigorously several times to ensure that the ingredients are dissolved. Drink at a rate of 8 ounces every 10 minutes until the entire contents are consumed or the rectal effluent is clear. A loose watery bowel movement should result in approximately one hour.

After reconstitution, keep solution refrigerated 2° to 8°C (36° to 46°F). Do not freeze. Use within 48 hours, discard unused portion.

Administration via a Nasogastric Tube For patients with a nasogastric tube, administer the reconstituted PE…

💊 Dosage Forms and Strengths 101 words

3 DOSAGE FORMS AND STRENGTHS For Oral Solution: 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride and 2.97 g potassium chloride as a white powder. When reconstituted with water to a volume of 4 liters, the solution contains 59 g/L PEG-3350, 5.69 g/L sodium sulfate, 1.69 g/L sodium bicarbonate, 1.47 g/L sodium chloride and 0.743 g/L potassium chloride. For Oral Solution: 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, 2.97 g potassium chloride and 3 g flavoring ingredients per 4 liters.

Contraindications 106 words

4 CONTRAINDICATIONS PEG-3350 and Electrolytes for Oral Solution is contraindicated in the following conditions: Gastrointestinal (GI) obstruction [see Warnings and Precautions ( 5.6 )] Bowel perforation [see Warnings and Precautions ( 5.6 )] Toxic colitis or toxic megacolon Gastric retention Ileus Hypersensitivity to any component of PEG-3350 and Electrolytes for Oral Solution [see Warnings and Precautions ( 5.8 )] Gastrointestinal (GI) obstruction ( 4 , 5.6 ) Bowel perforation ( 4 , 5.6 ) Toxic colitis or toxic megacolon ( 4 ) Gastric retention ( 4 ) Ileus ( 4 ) Hypersensitivity to components of PEG-3350 and Electrolytes for Oral Solution ( 4 , 5.8 )

⚠️ Warnings and Cautions ~3 min read

5 WARNINGS AND PRECAUTIONS Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after use. ( 5.1 , 5.2 , 7.1 ) Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias. ( 5.2 ) Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizure, including medications that lower the seizure threshold.

( 5.3 , 7.1 ) Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider testing. ( 5.4 , 7.1 , 8.6 ) Mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. ( 5.5 , 7.3 ) Patients at risk for aspiration: Observe during administration.

( 5.7 ) Hypersensitivity reactions including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur. ( 5.8 )

5.1Serious Fluid and Serum Chemistry Abnormalities Advise patients to hydrate adequately before, during, and after the use of PEG-3350 and Electrolytes for Oral Solution. Use caution in patients with congestive heart failure when replacing fluids. If a patient develops significant vomiting or signs of dehydration including signs of orthostatic hypotension after taking PEG-3350 and Electrolytes for Oral Solution, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN) and treat accordingly.

Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment. Correct fluid and electrolyte abnormalities before treatment with PEG-3350 and Electrolytes for Oral Solution. In addition, use caution when prescribing PEG-3350 and Electrolytes for Oral Solution for patients who have conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and renal impairment [see Drug Interactions ( 7.1 )] .

5.2Cardiac Arrhythmias There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing PEG-3350 and Electrolytes for Oral Solution for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.

5.3Seizures There have been reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of bowel preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.

Use caution when prescribing PEG-3350 and Electrolytes for Oral Solution for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia [see Drug Interactions ( 7.1 )] .

5.4Renal Impairment Use caution when prescribing PEG-3350 and Electrolytes for Oral Solution for patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs) [see Drug Interactions ( 7.1 )] . Advise these patients of the importance of a…

🤒 Adverse Reactions ~1 min read

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Renal impairment [see Warnings and Precautions ( 5.4 )] Colonic mucosal ulcerations and ischemic colitis [see Warnings and Precautions ( 5.5 )] Patients with significant gastrointestinal disease [see Warnings and Precautions ( 5.6 )] Aspiration [see Warnings and Precautions ( 5.7 )] The following adverse reactions associated with the use of PEG-3350 and Electrolytes for Oral Solution were identified in clinical trials or postmarketing reports.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or establish a causal relationship to drug exposure. Cardiovascular: arrhythmia, atrial fibrillation, peripheral edema, asystole, and acute pulmonary edema after aspiration [see Warnings and Precautions ( 5.2 )] . Nervous system: tremor, seizure [see Warnings and Precautions ( 5.3 )] Hypersensitivity: Urticaria/rash, pruritus, dermatitis, rhinorrhea, dyspnea, chest and throat tightness, fever, angioedema, anaphylaxis and anaphylactic shock [see Contraindications ( 4 ), Warnings and Precautions ( 5.8 )] Gastrointestinal: Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients).

Other less common adverse reactions include: abdominal cramps, vomiting, “butterfly-like” infiltrates on chest X-ray after vomiting and aspirating PEG, anal irritation, and upper GI bleeding from Mallory-Weiss Tear, esophageal perforation [usually with gastroesophageal reflux disease (GERD)]. Most common adverse reactions are: nausea, abdominal fullness, bloating abdominal cramps, vomiting and anal irritation. To report SUSPECTED ADVERSE REACTIONS, contact Affordable Pharmaceuticals, LLC at 1-800-514-5617 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 193 words

7 DRUG INTERACTIONS Some drugs increase risks due to fluid and electrolyte changes ( 7.1 )

7.1Drugs that May Increase Risks Due to Fluid and Electrolyte Abnormalities Use caution when prescribing PEG-3350 and Electrolytes for Oral Solution for patients with conditions and/or who are using medications that increase the risk for fluid and electrolyte disturbances or may increase the risk of renal impairment, seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 )] . Consider additional patient evaluations as appropriate.

7.2Potential for Reduced Drug Absorption PEG-3350 and Electrolytes for Oral Solution can reduce the absorption of other administered drugs. Administer oral medications within one hour before the start of administration of PEG-3350 and Electrolytes for Oral Solution [see Dosage and Administration ( 2.1 )] .

7.3Stimulant Laxatives Concurrent use of stimulant laxatives and PEG-3350 and Electrolytes for Oral Solution may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking PEG-3350 and Electrolytes for Oral Solution [see Warnings and Precautions ( 5.5 )] .

👥 Use in Specific Populations ~1 min read

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Animal reproduction studies have not been conducted with PEG-3350 and Electrolytes for Oral Solution. It is also not known whether PEG-3350 and Electrolytes for Oral Solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. PEG-3350 and Electrolytes for Oral Solution should be given to a pregnant woman only if clearly needed.

8.3Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PEG-3350 and Electrolytes for Oral Solution is administered to a nursing woman.

8.4Pediatric Use Safety and effectiveness of PEG-3350 and Electrolytes for Oral Solution in pediatric patients have not been established.

8.5Geriatric Use Clinical studies of PEG-3350 and Electrolytes for Oral Solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

8.6Renal Impairment Use PEG-3350 and Electrolytes for Oral Solution with caution in patients with renal impairment or patients taking concomitant medications that may affect renal function [see Drug Interactions ( 7.1 )] . These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration before, during and after use of PEG-3350 and Electrolytes for Oral Solution and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Warnings and Precautions ( 5.4 )] .

🤰 Pregnancy 60 words

8.1Pregnancy Animal reproduction studies have not been conducted with PEG-3350 and Electrolytes for Oral Solution. It is also not known whether PEG-3350 and Electrolytes for Oral Solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. PEG-3350 and Electrolytes for Oral Solution should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 20 words

8.4Pediatric Use Safety and effectiveness of PEG-3350 and Electrolytes for Oral Solution in pediatric patients have not been established.

🧓 Geriatric Use 48 words

8.5Geriatric Use Clinical studies of PEG-3350 and Electrolytes for Oral Solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🧬 Clinical Pharmacology 88 words

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The primary mode of action is thought to be through the osmotic effect of polyethylene glycol 3350 which causes water to be retained in the colon and produces a watery stool.

12.2Pharmacodynamics PEG-3350 and Electrolytes for Oral Solution induces as diarrhea which rapidly cleanses the bowel, usually within four hours.

12.3Pharmacokinetics The pharmacokinetics of PEG3350 following administration of PEG-3350 and Electrolytes for Oral Solution were not assessed. Available pharmacokinetic information for oral PEG3350 suggests that it is poorly absorbed.

🧬 Mechanism of Action 35 words

12.1Mechanism of Action The primary mode of action is thought to be through the osmotic effect of polyethylene glycol 3350 which causes water to be retained in the colon and produces a watery stool.

📦 How Supplied / Storage and Handling 143 words

16 HOW SUPPLIED/STORAGE AND HANDLING PEG-3350 and Electrolytes for Oral Solution is supplied in a 4-liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride and 2.97 g potassium chloride as a white powder. When reconstituted with water to a volume of 4 liters, the solution contains 59 g/L PEG-3350, 5.69 g/L sodium sulfate, 1.69 g/L sodium bicarbonate, 1.47 g/L sodium chloride and 0.743 g/L potassium chloride. PEG-3350 and Electrolytes for Oral Solution 4 Liter Disposable Jug NDC 10572-100-01 Pineapple Flavor PEG-3350 and Electrolytes for Oral Solution 4 Liter Disposable Jug NDC 10572-101-01 Storage Store in sealed container at 15° to 30°C (59° to 86°F).

Store reconstituted solution of PEG-3350 and Electrolytes for Oral Solution at 2° to 8°C (36° to 46°F). Do not freeze [see Dosage and Administration (2.1)] .

📦 Storage and Handling 38 words

Storage Store in sealed container at 15° to 30°C (59° to 86°F). Store reconstituted solution of PEG-3350 and Electrolytes for Oral Solution at 2° to 8°C (36° to 46°F). Do not freeze [see Dosage and Administration (2.1)] .

📋 Description 161 words

11 DESCRIPTION PEG-3350 and Electrolytes for Oral Solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 4 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder. Polyethylene Glycol 3350, USP Sodium Sulfate, USP The chemical name is Na 2 SO 4 .

The average Molecular Weight is 142.04. The structural formula is: Sodium Bicarbonate, USP The chemical name is NaHCO 3 . The average Molecular Weight is 84.01.

The structural formula is: Sodium Chloride, USP The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is: Na + Cl - Potassium Chloride, USP The chemical name is KCl.

The average Molecular Weight: 74.55. The structural formula is: K-Cl PEG Chemical Structure Na2SO4 Chemical Structure NaHCO3 Chemical Structure

💬 Information for Patients 220 words

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-Approved Patient Labeling (Medication Guide and Instructions for Use). Instruct patients: To reconstitute PEG-3350 and Electrolytes for Oral Solution with water prior to ingestion. Not to take other laxatives while they are taking PEG-3350 and Electrolytes for Oral Solution.

Not to take oral medications within 1 hour before the start or during the administration of PEG-3350 and Electrolytes for Oral Solution. To take only clear liquids but avoid red and purple liquids. To consume water or other clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy.

To follow the directions in the Instructions for Use on how to prepare and administer the product. If they experience severe bloating, distention or abdominal pain, to slow or temporarily discontinue drinking the solution and to contact their healthcare provider. To contact their healthcare provider if they develop signs and symptoms of dehydration or if they experience altered consciousness or seizures [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 )] .

To discontinue administration of the solution and contact their healthcare provider if they develop symptoms of a hypersensitivity reaction [see Warnings and Precautions ( 5.8 )] . Distributed by Affordable Pharmaceuticals, LLC, Braintree, MA 02185

💬 Medication Guide ~3 min read

Medication Guide PEG-3350 and Electrolytes for Oral Solution (PEG-3350 and i-lek-truh-lahyts for oral solution) Read this Medication Guide before you start taking PEG-3350 and Electrolytes for Oral Solution. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. What is the most important information I should know about PEG-3350 and Electrolytes for Oral Solution?

PEG-3350 and Electrolytes for Oral Solution and other osmotic bowel preparations can cause serious side effects, including: Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause: abnormal heartbeats (arrhythmias) that can cause death. seizures. This can happen even if you have never had a seizure. kidney problems.

Your chance of having fluid loss and changes in body salts with PEG-3350 and Electrolytes for Oral Solution is higher if you: have heart problems. have kidney problems. take water pills or non-steroidal anti-inflammatory drugs (NSAIDS). Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid (dehydration) while taking PEG-3350 and Electrolytes for Oral Solution: vomiting that prevents you from keeping down the solution. dizziness. urinating less often than normal. headache.

See Section “What are the possible side effects of PEG-3350 and Electrolytes for Oral Solution” for more information about side effects. What is PEG-3350 and Electrolytes for Oral Solution? PEG-3350 and Electrolytes for Oral Solution is a prescription medicine used by adults to clean the colon before a colonoscopy or barium enema X-ray examination.

PEG-3350 and Electrolytes for Oral Solution cleans your colon by causing you to have diarrhea (loose stools). Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy. It is not known if PEG-3350 and Electrolytes for Oral Solution is safe and effective in children.

Who should not take PEG-3350 and Electrolytes for Oral Solution? Do not takePEG-3350 and Electrolytes for Oral Solution if your healthcare provider has told you that you have: a blockage in your bowel (obstruction). an opening in the wall of your stomach or intestine (bowel perforation). a very dilated intestine (toxic megacolon). problems with food and fluid emptying from your stomach (gastric retention). a problem with food moving too slowly through your intestines (ileus). an allergy to any of the ingredients in PEG-3350 and Electrolytes for Oral Solution.

See the end of this Medication Guide for a complete list of ingredients in PEG-3350 and Electrolytes for Oral Solution. What should I tell my healthcare provider before taking PEG-3350 and Electrolytes for Oral Solution? Before you take PEG-3350 and Electrolytes for Oral Solution, tell your healthcare provider if you: have heart problems. have stomach or bowel problems. have ulcerative colitis. have problems with swallowing or gastric reflux. have a history of seizures. are withdrawing from drinking alcohol. have a low blood salt (sodium) level. have kidney problems. have any other medical conditions. are pregnant.

It is not known if PEG-3350 and Electrolytes for Oral Solution will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. are breastfeeding or plan to breastfeed. It is not known if PEG-3350 and Electrolytes for Oral Solution passes into your breast milk.

You and your healthcare provider should decide if you will take PEG-3350 and Electrolytes for Oral Solution while breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. PEG-3350 and Electrolytes for Oral Solution may affect how other medicines work.

Do not take medicines by mouth within 1 hour of starting PEG-3350 and Electrolytes for Oral Solution or after you start t…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.