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SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM 13.13 g/133.1mL; 2.35 g/133.1mL; 1.2 g/133.1mL Solution, Concentrate, 2 bottles

by Affordable Pharmaceuticals, LLC · 2 BOTTLE, PLASTIC in 1 CARTON (10572-112-01) / 133.1 mL in 1 BOTTLE, PLASTIC

NDC 10572-0112-01

🏷️ FDA NDC (as labeled) 10572-112-01 billing pads the product segment with a zero

Rx only Brand On market Non-controlled

🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 10572-112-01

Product NDC 10572-112

11-digit billing NDC 10572011201

RxCUI 1001689, 1120068, 2390767

UNII DE08037SAB, 0YPR65R21J, 1K573LC5TV

UPC 0310572011015, 0310572111012

Application # NDA022372

SPL Set ID f86bdcc8-e643-4160-89ae-01c89bee842d

Established class (EPC) Calculi Dissolution Agent; Inhibition Large Intestine Fluid/E

Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2010-08-05

Route ORAL

Dosage form SOLUTION, CONCENTRATE

Substance SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE, UNSPECIFIED FORM

TE code (Orange Book) AA · RLD · RS

Why two NDCs? The FDA registers this code as 10572-112-01 — 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 → 10572-0112-01. 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.

🏭 Manufacturer & labeler

LabelerAffordable Pharmaceuticals, LLC

Application holderAZURITY PHARMACEUTICALS INC

FDA applicationNDA022372 (NDA)

Labeler code10572

First marketedAug 2010

Product typeHuman Prescription Drug

Portfolio4 products on file

🔎 All NDCs from Affordable Pharmaceuticals, LLC

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

📖 What it is MedlinePlus · NLM

Magnesium sulfate, potassium sulfate, and sodium sulfate is used to empty the colon (large intestine, bowel) before a colonoscopy (examination of the inside of the colon to check for colon cancer and other abnormalities) in adults and children 12 years of age and older so that the doctor will have a clear view of the walls of the colon. Magnesium sulfate, potassium sulfate, and sodium sulfate is in a class of medications called osmotic laxatives. It works by causing watery diarrhea so that the stool can be emptied from the colon.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

This solution works by drawing water into your intestines so your bowel is thoroughly flushed out before your colonoscopy — your doctor needs a clear, clean view of the colon wall....
What exactly does this prep do, and why do I have to drink so much water with it?
Yes, but timing matters. Take all your regular oral medications at least one hour before you start each dose of the prep, since the solution can reduce how well your body absorbs o...
Can I take my regular medications while I'm doing the prep?

📖 Read our full Magnesium Sulfate, Potassium Sulfate, and Sodium Sulfate guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

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

FlavorBerry

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
UNII 817L1N4CKP
Malic acid is a naturally occurring organic acid found in fruits. It works as a buffer and flavor agent to maintain the medicine's pH balance and add tartness to the product.
UNII OJ245FE5EU
Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
UNII 96K6UQ3ZD4
Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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 system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate 13.13 g/133.1mL; 2.35 g/133.1mL; 1.2 g/133.1mL 52536-0177-01	Wilshire	2 bottles	—	AA	FDA listed	—
SUPREP Bowel Prep 13.13 g/133.1mL; 2.35 g/133.1mL; 1.2 g/133.1mL 52268-0112-01	Braintree	2 bottles	—	AA	FDA listed	—
Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate 13.13 g/133.1mL; 2.35 g/133.1mL; 1.2 g/133.1mLthis 10572-0112-01	Affordable	2 bottles	—	AA	FDA listed	—
SUPREP Bowel Prep 13.13 g/133.1mL; 2.35 g/133.1mL; 1.2 g/133.1mL 24338-0177-01	Azurity	2 bottles	—	AA	FDA listed	—

About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.

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

🏛️

2010

First FDA approval

Aug 2010

📍

2026

Currently FDA-listed

16 years listed

🛡️

2027

Latest patent/protection listed

not a guaranteed launch date

✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Aug 2027. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.

📅 FDA approved Aug 5, 2010 AA TE-rated RLD RS ⏳ ~0.9 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book

Exclusivity ODE-315

2010 2012 2014 2016 2018 2020 2022 2024 2026

Today

LOE

Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo

🏛️FDA exclusivity

FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.

🧪Product / substance patents

Patents covering the active ingredient, product, formulation, or related drug features.

🎯Method-of-use patents

Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.

🛈 What do these terms mean?

Patent: Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent: Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent: Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent: A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label: A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity: FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV: A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS: Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating: FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity): The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

FDA exclusivity

Code	What it grants	Expires
ODE-315	Orphan Drug Exclusivity (7-year)	Aug 5, 2027

Common questions

Is there a generic version of this drug?

Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for this drug. See the alternatives section for substitutable, lower-cost products.

The FDA approved a generic — why can’t I get it at my pharmacy yet?

FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.

Why do different websites show different generic release dates?

Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.

What does “FDA listed” mean?

It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.

What does a patent or protection date mean here?

It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).

What does “current Orange Book estimate” mean?

It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.

Can a generic come out before the last patent expires?

Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.

Can a generic come out after the listed dates?

Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.

What is the difference between patents and exclusivity?

Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.

Why are there multiple patent dates?

One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.

Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.

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.

🔬 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 Sodium sulfate, potassium sulfate, magnesium sulfate — the ingredient across all brands.

Top reported reactions

Vomiting1,637

Nausea1,147

Abdominal Distension393

Abdominal Pain377

Headache371

Dizziness226

Abdominal Pain Upper194

Age at onset

Adult143

Elderly70

Reporter sex

Male · 26%

Female · 73%

Unknown · 0%

Serious outcomes

Hospitalization222

Death31

Disabling26

Life-threatening15

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Marketing start	Status
10572-0112-01 You're viewing this	2 BOTTLE, PLASTIC in 1 CARTON (10572-112-01) / 133.1 mL in 1 BOTTLE, PLASTIC	2021-01-05	Active

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 10572-112-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 10572-0112-01, written without dashes as 10572011201. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 10572-0112-01, the first segment (10572) is the labeler code FDA assigned to Affordable Pharmaceuticals, LLC; the middle segment (0112) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Affordable Pharmaceuticals, LLC. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Affordable Pharmaceuticals, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

🎯 Indications and Usage 73 words ▾

1 INDICATIONS AND USAGE Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adult and pediatric patients 12 years of age and older. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Preparation and Administration ( 2.2 ) Must dilute in water prior to ingestion. Administration of two bottles of SUPREP Bowel Prep Kit is required for a complete preparation for colonoscopy. One bottle is equivalent to one dose.

Must consume additional water after each dose. Stop consumption of all fluids at least 2 hours before the colonoscopy. Recommended Dosage and Administration Split-Dose (two-day) regimen consists of two doses of SUPREP Bowel Prep Kit: first dose during the evening prior to colonoscopy and second dose the next day, during the morning of colonoscopy.

( 2.1 , 2.3 , 2.4 ) Recommended SUPREP Bowel Prep Kit dosage is: Adults: Two 6-ounce doses. ( 2.3 ) Pediatric Patients 12 Years of Age and Older: Two 4.5-ounce doses. ( 2.4 ) For complete information on preparation before colonoscopy and administration of the dosage regimen, see full prescribing Information.

( 2.1 , 2.2 , 2.3 , 2.4 )

2.1Dosage and Administration Overview Administration of two bottles of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution and additional water is required for a complete preparation for colonoscopy. One bottle of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is equivalent to one dose. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is supplied in two dosage strengths [see Dosage Forms and Strengths ( 3 )] .

The recommended dosage is: Adults: Two 6-ounce doses [see Dosage and Administration ( 2.3 )]. Pediatric patients 12 years of age and older: Two 4.5-ounce doses [see Dosage and Administration ( 2.4 )].

2.2Important Preparation and Administration Instructions Correct fluid and electrolyte abnormalities before treatment with Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution [see Warnings and Precautions ( 5.1 )] Must dilute Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in water before ingestion. Must consume additional water after each dose of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. On the day before colonoscopy, consume only a light breakfast or clear liquids (e.g., water, strained fruit juice without pulp, lemonade, plain coffee or tea, chicken broth gelatin dessert without fruit).

On the day of the colonoscopy only consume clear liquids up to two hours prior to colonoscopy. Do not eat solid food or drink milk or eat or drink anything colored red or purple. Do not drink alcohol.

Do not take other laxatives while taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. Do not take oral medications within one hour of starting each dose of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine, take these medications at least 2 hours before and not less than 6 hours after administration of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution [see Drug Interactions ( 7.2 )] .

Stop consumption of all fluids at least 2 hours prior to the colonoscopy.

2.3Recommended Dosage and Administration for Adults The recommended Split-Dose (two-day) regimen for adults consists of two 6-ounce doses of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution: the first dose during the evening prior to colonoscopy and the second dose the next day, during the morning of the colonoscopy. Each dose consists of one bottle of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution with additional water. The total volume of liquid required for colon cleansing (using two bottles) is 3 quarts.

The following are recommended dosage and administration instructions for adults: Dose 1 – On the Day Prior to Colonoscopy: May consume a light breakfast, or only clear liquids (no solid food). In the evening before the procedure, pour the contents of one bottle of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate…

💊 Dosage Forms and Strengths 192 words ▾

3 DOSAGE FORMS AND STRENGTHS Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for adults) : Two bottles each containing 6 ounces of an oral solution of 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate as a clear to slightly hazy liquid. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for pediatric patients 12 years of age and older) : Two bottles each containing 4.5 ounces of an oral solution of 13.13 grams sodium sulfate, 2.35 grams potassium sulfate, and 1.2 grams magnesium sulfate as a clear to slightly hazy liquid.

When diluted as directed, the solution is clear and colorless. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for adults) : Two bottles each containing 6 ounces of an oral solution of 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate. ( 3 ) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for pediatric patients 12 years of age and older) : Two bottles each containing 4.5-ounces of an oral solution of 13.13 grams sodium sulfate, 2.35 grams potassium sulfate, and 1.2 grams magnesium sulfate.

( 3 )

⛔ Contraindications 109 words ▾

4 CONTRAINDICATIONS Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is contraindicated in the following conditions: Gastrointestinal obstruction or ileus [see Warnings and Precautions ( 5.6 )] Bowel perforation [see Warnings and Precaution ( 5.6 )] Toxic colitis or toxic megacolon Gastric retention Hypersensitivity to any of the ingredients in Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution [see Warnings and Precautions ( 5.8 ) and Description ( 11 )] Gastrointestinal obstruction or ileus ( 4 , 5.6 ) Bowel perforation ( 4 , 5.6 ) Toxic colitis or toxic megacolon ( 4 ) Gastric retention ( 4 ) Hypersensitivity to any ingredient ( 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 each use. ( 5.1 , 7.1 ) Cardiac arrhythmias : Consider pre-dose and post-colonoscopy ECGs in patients at increased risk. ( 5.2 ) Seizures : Use caution in patients with a history of seizures and patients at increased risk of seizures, 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 laboratory testing. ( 5.4 , 7.1 ) Suspected GI obstruction or perforation : Rule out the diagnosis before administration. ( 4 , 5.6 ) 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 all patients to hydrate adequately before, during, and after the use of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. If a patient develops significant vomiting or signs of dehydration after taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN). 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 Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. Use Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution with caution in patients with 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 )] . Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution can cause temporary elevations in uric acid [see Adverse Reactions ( 6.1 )] .

Uric acid fluctuations in patients with gout may precipitate an acute flare. The potential for uric acid elevation should be considered before administering Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution to patients with gout or other disorders of uric acid metabolism.

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 Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate 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 Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate 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 )] .

5.4Use in Patients with Risk of Renal Injury Use Sodium Sulfate, Potassium Sulfate and Magnesium…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions are: Adults (>2%): overall discomfort, abdominal distention, abdominal pain, nausea, and vomiting. ( 6.1 ) Pediatric Patients (>10%): nausea, abdominal pain, abdominal bloating and vomiting. ( 6.1 ) 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 .

The following important adverse reactions for bowel preparations are described elsewhere in the labeling: Serious Fluid and Serum Chemistry Abnormalities [see Warnings and Precautions ( 5.1 )] Cardiac Arrhythmias [see Warnings and Precautions ( 5.2 )] Seizures [see Warnings and Precautions ( 5.3 )] Use in Patients with Risk of Renal Injury [see Warnings and Precautions ( 5.4 )] Colonic Mucosal Ulceration 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 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.8 )]

6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice. Adults The safety of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution was evaluated in a multi-center, randomized, active controlled trial in 379 adult patients undergoing colonoscopy [see Clinical Studies ( 14 )] .

Most Common Adverse Reactions Table 1 shows the most common adverse reactions reported in at least 2% of patients receiving Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution or the control (a bowel prep containing polyethylene glycol and electrolytes (PEG + E)) administered in split-dose (2-day) regimens. Table 1: Common Adverse Reactions* in Adult Patients Undergoing Colonoscopy in a Randomized, Active Controlled Trial Symptom Split-Dose (2-Day) Regimen Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution % N=190 PEG + E product % N=189 Overall Discomfort 54 67 Abdominal Distension 40 52 Abdominal Pain 36 43 Nausea 36 33 Vomiting 8 4 * reported in at least 2% of patients Laboratory Abnormalities Table 2 shows the most common laboratory abnormalities (at least 10% in either treatment group and more than 2% difference between groups) for patients who developed new abnormalities of important electrolytes and uric acid after completing the bowel preparation with either Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution or PEG+E administered as a split-dose (2-day) regimen.

Table 2: Adult Patients with Normal Baseline Serum Chemistry with A Shift to an Abnormal Value While on the Split-Dose (2-Day) Regimen 1 Day of Colonoscopy N (%) 2 Day 30 N (%) 2 Bicarbonate (low) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 20 (13) 7 (4) PEG + Electrolytes 24 (15) 4 (3) Bilirubin, total (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 14 (9) 0 (0) PEG + Electrolytes 20 (12) 3 (2) BUN (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 2 (2) 14 (11) PEG + Electrolytes 4 (3) 19 (15) Calcium (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 16 (10) 8 (5) PEG + Electrolytes 6 (4) 6 (4) Chloride (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 4 (2) 6 (4) PEG + Electrolytes 20 (12) 6 (4) Osmolality (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 8 (6) NA PEG + Electrolytes 19 (13) NA Uric acid (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 27 (24) 13 (12) PEG + Electrolytes 12 (10) 20 (17) 1 The study was not designed to support comparative claims for the laboratory abnormalities reported in this table.

2 Percent (n/N) of patients whe…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Drugs that increase risk of fluid and electrolyte imbalance. ( 7.1 )

7.1Drugs That May Increase Risks of Fluid and Electrolyte Abnormalities Use caution when prescribing Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution to patients taking medications that increase the risk of fluid and electrolyte disturbances or may increase the risk of adverse events of 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 )].

7.2Potential for Reduced Drug Absorption Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution can reduce the absorption of other co-administered drugs [see Dosage and Administration ( 2.1 )] . Administer oral medications at least one hour before starting each dose of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. Administer tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, and penicillamine at least 2 hours before and not less than 6 hours after administration of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution to avoid chelation with magnesium.

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

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproductive studies have not been conducted with Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

8.2Lactation Risk Summary There are no data available data on the presence of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in human or animal milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution and any potential adverse effects on the breastfed child from Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 4.5-ounce doses) have been established for cleansing of the colon as a preparation for colonoscopy in pediatric patients 12 years of age and older. Use of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in this age group is supported by evidence from an adequate and well-controlled trial of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in adults and a single, dose-ranging, controlled trial in 89 pediatric patients 12 years to 16 years of age [see Clinical Studies ( 14 )] .

In the pediatric trial, Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 6-ounce doses) did not demonstrate additional treatment benefit and more patients reported gastrointestinal adverse reactions compared to Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 4.5-ounce doses). Therefore, Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 6-ounce doses) is not recommended for pediatric patients 12 years of age and older [see Dosage and Administration ( 2.3 )] .

The safety profile of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 4.5-ounce doses) in this pediatric population was similar to that seen in adults [see Adverse Reactions ( 6.1 )] . The safety and effectiveness of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in pediatric patients less than 12 years of age have not been established.

8.5Geriatric Use Of the 375 patients who received Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in clinical trials, 94 (25%) were 65 years of age or older, and 25 (7%) were 75 years of age or older. No overall differences in safety or effectiveness of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, administered as the recommended split-dose (2-day) regimen, were observed between geriatric patients and younger patients. Geriatric patients reported more vomiting when Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution was given as a one-day preparation (not a recommended regimen).

Elderly patients are more likely to have decreased hepatic, renal or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities [see Warnings and Precautions ( 5.1 )] .

8.6Renal Impairment Use Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution with caution in patients with renal i…

🤰 Pregnancy 115 words ▾

🧒 Pediatric Use ~1 min read ▾

🧓 Geriatric Use 132 words ▾

🆘 Overdosage 60 words ▾

10 OVERDOSAGE Overdosage of more than the recommended dose of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution may lead to severe electrolyte disturbances, as well as dehydration and hypovolemia, with signs and symptoms of these disturbances. [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 ) ] . Monitor for fluid and electrolyte disturbances and treat symptomatically.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Sulfate salts provide sulfate anions, which are poorly absorbed. The osmotic effect of unabsorbed sulfate anions and the associated cations causes water to be retained within the gastrointestinal tract.

12.2Pharmacodynamics No formal pharmacodynamic studies have been conducted with Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution.

12.3Pharmacokinetics Absorption and Elimination After administration of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in six healthy subjects, the time at which serum sulfate reached its highest point (T max ) was approximately 17 hours after the first dose or approximately 5 hours after the second dose, and then declined with a half-life of 8.5 hours. Excretion Fecal excretion was the primary route of sulfate elimination. Specific Populations Patients with Renal Impairment The disposition of sulfate after ingestion of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution was studied in patients (N=6) with moderate renal impairment (creatinine clearance of 30 to 49 mL/min).

In patients with moderate renal impairment, mean AUC was 54% higher and mean C max was 44% higher, than healthy subjects. The mean sulfate concentrations in healthy subjects and in patients with moderate renal impairment returned to their respective baselines by Day 6 after dose initiation. Urinary excretion of sulfate over 30 hours after the first dose was approximately 16% lower in patients with moderate renal impairment than in healthy subjects.

These differences are not considered clinically meaningful. Patients with Hepatic Impairment The disposition of sulfate after ingestion of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution was studied in patients (N=6) with mild to moderate hepatic impairment (Child-Pugh grades A and B). Systemic exposure of serum sulfate (AUC and C max ) was similar between healthy subjects and patients with hepatic impairment.

The mean sulfate concentrations in healthy subjects and in patients with mild to moderate hepatic impairment returned to their respective baselines by Day 6 after dose initiation. Urinary excretion of sulfate over 30 hours after the first dose was similar between patients with hepatic impairment and healthy subjects.

🧬 Mechanism of Action 33 words ▾

📦 How Supplied / Storage and Handling 166 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for adults) (NDC 10572-012-01) contains: Two bottles (NDC 10572-011-01) each containing 6-ounces of an oral solution of 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate as a clear to slightly hazy liquid. When diluted as directed, the solution is clear and colorless. One (1) mixing container with a 16-ounce fill line.

Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for pediatric patients 12 years of age and older) (NDC 10572-112-01) contains: Two bottles (NDC 10572-111-01) each containing 4.5-ounces of an oral solution of 13.13 grams sodium sulfate, 2.35 grams potassium sulfate, and 1.2 grams magnesium sulfate as a clear to slightly hazy liquid. When diluted as directed, the solution is clear and colorless. One (1) mixing container with a 12-ounce fill line.

Store at 20° to 25°C (68° to 77°F). Excursions permitted between 15° to 30°C (59° to 86°F). See USP controlled room temperature.

📦 Storage and Handling 22 words ▾

Store at 20° to 25°C (68° to 77°F). Excursions permitted between 15° to 30°C (59° to 86°F). See USP controlled room temperature.

📋 Description 217 words ▾

11 DESCRIPTION Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for adults) is an osmotic laxative and is provided as two bottles each containing 6 ounces of solution. Each bottle contains: 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate. Inactive ingredients include: citric acid USP, flavoring ingredients, malic acid FCC, sodium benzoate, NF, sucralose, purified water, USP.

Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for pediatric patients 12 years of age and older) is an osmotic laxative and is provided as two bottles each containing 4.5 ounces of solution. Each bottle contains: 13.13 grams sodium sulfate, 2.35 grams potassium sulfate, and 1.2 grams magnesium sulfate. Inactive ingredients include: citric acid USP, flavoring ingredients, malic acid FCC, sodium benzoate, NF, sucralose, purified water, USP.

Sodium Sulfate, USP The chemical name is Na 2 SO 4 . The average Molecular Weight is 142.04. The structural formula is: Potassium Sulfate, FCC, purified The chemical name is K 2 SO 4 .

The average Molecular Weight is 174.26. The structural formula is: Magnesium Sulfate, USP The chemical name is MgSO 4 . The average Molecular Weight: 120.37.

The structural formula is: Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution also contains a polypropylene mixing container. sod sulfate pot sulfate mg sulfate

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide). Instruct patients or caregivers: Must dilute Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution before ingestion. Must consume additional water after each dose of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution.

On the day before colonoscopy, consume only a light breakfast or clear liquids (e.g., water, apple or orange juice without pulp, lemonade, coffee, tea, or chicken broth). On the day of the colonoscopy only consume clear liquids up to two hours prior to colonoscopy. Two doses of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution are required for a complete preparation for colonoscopy.

One bottle of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is equivalent to one dose. Do not to take other laxatives while taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. Do not eat solid food or drink milk or eat or drink anything colored red or purple.

Do not drink alcohol. Do not take oral medications within one hour of starting each dose of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine, take these medications at least 2 hours before and not less than 6 hours after administration of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution [see Drug Interactions ( 7.2 )] .

Stop consumption of all fluids at least 2 hours prior to colonoscopy. Contact their healthcare provider if they develop significant vomiting or signs of dehydration after taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution or if they experience cardiac arrhythmias or seizures [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 )] . Seek immediate medical care should signs or symptoms of a hypersensitivity reaction occur [see Warnings and Precautions ( 5.8 )] .

Distributed by Affordable Pharmaceuticals, LLC Braintree, MA 02185 U.S. Patent 6,946,149

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (so-DEE-um sul-fate, po-TASS ee-um sul-fate and mag-NEE-see-um sul-fate) Read and understand this Medication Guide at least 2 days before your colonoscopy and again before you start taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. What is the most important information I should know about Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution? Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution and other 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: o abnormal heartbeats that can cause death. o seizures. This can happen even if you have never had a seizure. o kidney problems. Your chance of having fluid loss and changes in body salts with Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate 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 Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution: o vomiting o urinating less often than normal o dizziness o headache See "What are the possible side effects of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution?" for more information about side effects.

What is Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution? Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is a prescription medicine used by adults and children 12 years of age and older to clean the colon before a colonoscopy. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution cleans your colon by causing you to have diarrhea.

Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy. It is not known if Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is safe and effective in children under 12 years of age. Do not take Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution if your healthcare provider has told you that you have: • a blockage in your intestine (bowel obstruction). • an opening in the wall of your stomach or intestine (bowel perforation). • a very dilated intestine (toxic megacolon). • problems with the emptying of food and fluid from your stomach (gastric retention). • an allergy to any of the ingredients in Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution.

See the end of this Medication Guide for a complete list of ingredients in Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. Before taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, tell your healthcare provider about all of your medical conditions, including if you: • have problems with serious loss of body fluid (dehydration) and changes in blood salts (electrolytes). • have gout. • have heart problems including an irregular heartbeat, especially a condition called "QT prolongation". • have a history of seizures or take medicines for seizures. • are withdrawing from drinking alcohol or from taking benzodiazepines. • have a low blood salt (sodium) level. • have kidney problems or take medicines for kidney problems. • have stomach or bowel problems including ulcerative colitis. • have problems with swallowing or gastric reflux. • are pregnant or plan to become pregnant.

It is not known if Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution will harm your unborn baby. Talk to your healthcare provider if you are pregnant. • are breastfeeding or plan to breastfeed. It is not known if Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution passes into your breast milk.

Y…

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

abdominal distension: A swollen or stretched feeling in the belly, often from gas or fluid.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

bilirubin: A yellow substance the liver normally clears from the blood; high levels can turn the skin or the whites of the eyes yellow.

BUN: Blood urea nitrogen, a waste product measured in a blood test that helps show how well the kidneys are working.

cardiomyopathy: A disease of the heart muscle that makes it harder for the heart to pump blood.

Child-Pugh: A scoring system doctors use to grade how severe long-term liver disease is, often to help set the right medicine dose.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

colitis: Swelling and irritation of the inner lining of the large intestine, or colon.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

electrolyte: A mineral in the blood and body fluids, such as sodium, potassium, or calcium, that carries a small electric charge and helps the body work.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

gout: A type of arthritis with sudden, painful, swollen joints caused by uric acid crystals.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypocalcemia: A lower-than-normal level of calcium, a mineral, in the blood.

hypokalemia: A lower-than-normal level of potassium, an important mineral, in the blood.

hypomagnesemia: A lower-than-normal level of magnesium, a mineral, in the blood.

hyponatremia: A lower-than-normal level of sodium (salt) in the blood.

ileus: A slowdown or stop in the normal movement of the intestines, so food and waste do not pass through.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

lactation: The making and release of milk from a mother's breasts after giving birth.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

perforation: A hole that forms all the way through the wall of the stomach or intestine.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

QT prolongation: A longer-than-normal electrical recovery time between heartbeats, seen on a heart tracing (ECG), which can raise the chance of a dangerous heart rhythm.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

ulceration: The forming of an open sore on the skin or on a lining inside the body, such as the stomach.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 10572-0100-01 · Affordable 10572-0302-01 · Affordable →

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.

SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM 13.13 g/133.1mL; 2.35 g/133.1mL; 1.2 g/133.1mL Solution, Concentrate, 2 bottles

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