NDC 10572-100 Peg-3350 And Electrolytes

Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride

NDC Product Code 10572-100

NDC CODE: 10572-100

Proprietary Name: Peg-3350 And Electrolytes What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat occasional constipation. It works by holding water in the stool to soften the stool and increases the number of bowel movements. It is known as an osmotic-type laxative. This medication is also available without a prescription. If you are taking this medication for self-treatment, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist. (See also Precautions.)
  • Drug uses not available
  • This product is used to treat dryness inside the nose (nasal passages). It helps add moisture inside the nose to dissolve and soften thick or crusty mucus. In babies and young children with stuffy noses who cannot blow their noses, using this product helps to make the mucus easier to remove with a nasal bulb syringe. This helps relieve stuffiness and makes breathing easier. This product contains a purified gentle salt solution (also called saline or sodium chloride solution). It does not contain any medication.
  • This medication is a mineral supplement used to treat or prevent low amounts of potassium in the blood. A normal level of potassium in the blood is important. Potassium helps your cells, kidneys, heart, muscles, and nerves work properly. Most people get enough potassium by eating a well-balanced diet. Some conditions that can lower your body's potassium level include severe prolonged diarrhea and vomiting, hormone problems such as hyperaldosteronism, or treatment with water pills/diuretics.

NDC Code Structure

  • 10572 - Affordable Pharmaceuticals, Llc

NDC 10572-100-01

Package Description: 4 L in 1 JUG

NDC Product Information

Peg-3350 And Electrolytes with NDC 10572-100 is a a human prescription drug product labeled by Affordable Pharmaceuticals, Llc. The generic name of Peg-3350 And Electrolytes is polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride. The product's dosage form is powder, for solution and is administered via oral form.

Labeler Name: Affordable Pharmaceuticals, Llc

Dosage Form: Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Peg-3350 And Electrolytes Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • POLYETHYLENE GLYCOL 3350 236 g/4L
  • SODIUM SULFATE ANHYDROUS 22.74 g/4L
  • SODIUM BICARBONATE 6.74 g/4L
  • SODIUM CHLORIDE 5.86 g/4L
  • POTASSIUM CHLORIDE 2.97 g/4L

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Potassium Compounds - [CS]
  • Potassium Salt - [EPC] (Established Pharmacologic Class)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Affordable Pharmaceuticals, Llc
Labeler Code: 10572
FDA Application Number: NDA019011 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA AUTHORIZED GENERIC - A product marketed as a “generic” drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-01-2009 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Polyethylene glycol-electrolyte solution (PEG-ES)

Polyethylene glycol-electrolyte solution (PEG-ES) is pronounced as (pol ee eth' i leen) (glye' col)

Why is polyethylene glycol-electrolyte solution (peg-es) medication prescribed?
Polyethylene glycol-electrolyte solution (PEG-ES) is used to empty the colon (large intestine, bowel) before a colonoscopy (examination of the inside of the colon to chec...
[Read More]

* Please review the disclaimer below.

Peg-3350 And Electrolytes Product Label Images

Peg-3350 And Electrolytes Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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.

2.1 Dosage Overview

PEG-3350 and Electrolytes for Oral Solution, supplied as a powder, must be reconstituted with water before its use; it is not for direct ingestion [see Dosage and Administration (2.2), Warnings and Precautions (5.8)]. The 4 liter reconstituted PEG-3350 and Electrolytes for Oral Solution solution contains: 236 grams of polyethylene glycol (PEG) 3350, 22.74 grams sodium sulfate (anhydrous), 6.74 grams of sodium bicarbonate, 5.86 grams of sodium chloride, and 2.97 grams of potassium chloride. PEG-3350 and Electrolytes for Oral Solution is also available with pineapple flavor.

2.2 Administration Instructions Prior To Dosage

  • On the day prior to the colonoscopy, instruct patients to:
  • Take only clear liquids, but avoid red and purple liquids. Patients may consume a light breakfast.
  • Early in the evening prior to colonoscopy, fill the supplied container containing the PEG-3350 and Electrolytes for Oral Solution powder with lukewarm water (to facilitate dissolution) to the 4 liter fill line. The solution is clear and colorless when reconstituted to a final volume of 4 liters.
  • After capping the container, shake vigorously several times to ensure that the ingredients are dissolved. When reconstituted use within 48 hours.

2.3 Dosage

  • The following is the recommended dose of reconstituted PEG-3350 and Electrolytes for Oral Solution solution for adults. Instruct patients they may consume water or 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.
  • Adults: Instruct patients to drink a total of up to 4 liters at a rate of 240 mL (8 oz.) every 10 minutes, until 4 liters are consumed or the rectal effluent is clear. Rapid drinking of each portion is preferred to drinking small amounts continuously. For NGT, rate is 20-30 mL per minute (1.2 – 1.8 liters per hour).
  • The first bowel movements should occur approximately one hour after the start of PEG-3350 and Electrolytes for Oral Solution administration. Continue drinking until the watery stool is clear and free of solid matter.

3 Dosage Forms And Strengths

For oral solution: One 4 liter jug with powder for reconstitution with water.
Each 4 liter jug contains: polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g. When made up to 4 liters volume with water, the solution contains PEG-3350 17.6 mmol/L, sodium 125 mmol/L, sulfate 40 mmol/L, chloride 35 mmol/L, bicarbonate 20 mmol/L and potassium 10 mmol/L.

4 Contraindications

  • PEG-3350 and Electrolytes for Oral Solution is contraindicated in the following conditions:
  • Gastrointestinal (GI) obstruction, ileus, or gastric retention
  • Bowel perforation
  • Toxic colitis or toxic megacolon
  • Known allergy or hypersensitivity to any component of PEG-3350 and Electrolytes for Oral Solution[see How Supplied/Storage and Handling (16)]

5.1 Serious 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. Fluid and electrolyte abnormalities should be corrected 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)]

5.2 Cardiac 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). Pre-dose and post-colonoscopy ECGs should be considered in patients at increased risk of serious cardiac arrhythmias.

5.3 Seizures

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.

5.4 Renal 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 antiinflammatory drugs). Advise these patients of the importance of adequate hydration, and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients.

5.5 Colonic Mucosal Ulcerations And Ischemic Colitis

Administration of osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of stimulant laxatives and PEG-3350 and Electrolytes for Oral Solution may increase this risk. The potential for mucosal ulcerations resulting from the bowel preparation should be considered when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (IBD).

5.6 Use In Patients With Significant Gastrointestinal Disease

If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering PEG-3350 and Electrolytes for Oral Solution. If a patient experiences severe bloating, distention or abdominal pain, administration should be slowed or temporarily discontinued until the symptoms abate. If gastrointestinal obstruction or perforation is suspected, appropriate studies should be performed to rule out these conditions before administration of PEG-3350 and Electrolytes for Oral Solution.
Use with caution in patients with severe active ulcerative colitis.

5.7 Aspiration

Use with caution in patients with impaired gag reflex, unconscious, or semiconscious patients, and patients prone to regurgitation or aspiration. Such patients should be observed during administration of PEG-3350 and Electrolytes for Oral Solution, especially if it is administered via nasogastric tube.

5.8 Not For Direct Ingestion

The contents of each jug must be diluted with water to a final volume of 4 liters (4 L) and ingestion of additional water is important to patient tolerance. Direct ingestion of the undissolved powder may increase the risk of nausea, vomiting, dehydration, and electrolyte disturbances.

6 Adverse Reactions

The following adverse reactions have been identified during post-approval use of PEG-3350 and Electrolytes for Oral Solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients) to administration of PEG-3350 and Electrolytes for Oral Solution. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and usually subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis and (rarely) anaphylactic reaction have been reported which may represent allergic reactions.
Published literature contains isolated reports of serious adverse reactions following the administration of PEG-electrolyte solution products in patients over 60 years of age. These adverse events include upper GI bleeding from Mallory-Weiss Tear, esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and “butterfly-like” infiltrates on chest X-ray after vomiting and aspirating PEG.

7.1 Drugs That May Lead To Fluid And Electrolyte Abnormalities

Use caution when prescribing PEG-3350 and Electrolytes for Oral Solution for patients 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 prolonged QT in the setting of fluid and electrolyte abnormalities. Consider additional patient evaluations as appropriate [see Warnings and Precautions (5.1, 5.2, 5.3, and 5.4)] in patients taking these concomitant medications.

7.2 Potential For Altered Drug Absorption

Oral medication administered within one hour of the start of administration of PEG-3350 and Electrolytes for Oral Solution may be flushed from the gastrointestinal tract and the medication may not be absorbed properly.

7.3 Stimulant 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.

8.1 Pregnancy

Pregnancy Category C. 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.

8.3 Nursing 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.

8.4 Pediatric Use

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

8.5 Geriatric 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.

11 Description

For oral solution: Each 4 liter (4L) PEG-3350 and Electrolytes for Oral Solution jug contains a white powder for reconstitution. 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.
Each 4 liter jug contains: polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g. The solution is clear and colorless when reconstituted to a final volume of 4 liters with water. Polyethylene Glycol 3350, NF
Sodium Sulfate, USP
The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is:
Sodium Bicarbonate, USP
The chemical name is NaHCO3. 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

12.1 Mechanism 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.

12.2 Pharmacodynamics

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

12.3 Pharmacokinetics

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.

13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long term studies in animals have not been performed to evaluate carcinogenic potential of PEG-3350 and Electrolytes for Oral Solution. Studies to evaluate the possible impairment of fertility or mutagenic potential of PEG-3350 and Electrolytes for Oral Solution have not been performed.

16 How Supplied/Storage And Handling

In powdered form, for oral administration as a solution following reconstitution.
PEG-3350 and Electrolytes for Oral Solution is available in a disposable jug and a packet in powdered form containing:

Other

Disposable Jug: polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g. When made up to 4 liters volume with water, the solution contains PEG-3350 17.6 mmol/L, sodium 125 mmol/L, sulfate 40 mmol/L, chloride 35 mmol/L, bicarbonate 20 mmol/L and potassium 10 mmol/L.

Pineapple Flavor PEG-3350 and Electrolytes for Oral Solution: polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g, flavoring ingredients 3 g. When made up to 4 liters volume with water, the solution contains PEG 3350 17.6 mmol/L, sodium 125 mmol/L, sulfate 40 mmol/L, chloride 35 mmol/L, bicarbonate 20 mmol/L and potassium 10 mmol/L.

Storage And Handling

Storage:Store in sealed container at 59° to 86°F (15°C to 30°C). When reconstituted, keep solution refrigerated. Use within 48 hours, Discard unused portion.
Keep out of reach of children.
PEG-3350 and Electrolytes for Oral Solution                                NDC 10572-100-01
Pineapple Flavor PEG-3350 and Electrolytes for Oral Solution       NDC 10572-101-01

17 Patient Counseling Information

  • See FDA-Approved Patient Labeling (Medication Guide). Instruct patients:
  • To let you know if they have trouble swallowing or are prone to regurgitation or aspiration.
  • Not to take other laxatives while they are taking PEG-3350 and Electrolytes for Oral Solution.
  • To consume water or clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy.
  • That if they experience severe bloating, distention or abdominal pain, the administration of the solution should be slowed or temporarily discontinued until the symptoms abate. Advise patients to report these events to their health care provider.
  • That if they have hives, rashes, or any allergic reaction, they should discontinue the medication and contact their health care provider. Medication should be discontinued until they speak to their physician.
  • To contact their healthcare provider if they develop signs and symptoms of dehydration. [see Warnings and Precautions (5.1)].
  • That oral medication administered within one hour of the start of administration of PEG-3350 and Electrolytes for Oral Solution solution may be flushed from the GI tract and the medication may not be absorbed completely.
  • Distributed by Affordable Pharmaceuticals, LLC, Braintree, MA 02185

Spl Medguide

  • Medication GuidePEG-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 that can cause deathseizures. This can happen even if you have never had a seizure.
  • Kidney problemsYour 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. 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 take PEG-3350 and Electrolytes for Oral Solution if your heathcare 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)
  • Problems with food and fluid emptying from your stomach (gastric retention)
  • A very dilated intestine (toxic megacolon)
  • An allergy to any of the ingredients in PEG-3350 and Electrolytes for Oral Solution. See the end of this leaflet 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
  • 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 non-prescription medicines, vitamins, and herbal supplements. PEG-3350 and Electrolytes for Oral Solution may affect how other medicines work. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of PEG-3350 and Electrolytes for Oral Solution.
  • Especially tell your healthcare provider if you take:medicines for blood pressure or heart problems
  • Medicines for kidney problems
  • Medicines for seizures
  • Water pills (diuretics)
  • Non-steroidal anti-inflammatory medicines (NSAID) pain medicines
  • Laxatives
  • Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above.
  • Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
  • How should I take PEG-3350 and Electrolytes for Oral Solution?You must read, understand, and follow these instructions to take PEG-3350 and Electrolytes for Oral Solution the right way.Take PEG-3350 and Electrolytes for Oral Solution exactly as your healthcare provider tells you to take it.
  • Drink 240 mL (8 oz.) every 10 minutes. Rapid drinking of each portion is better than drinking small amounts.
  • The first bowel movement should occur approximately one hour after you start drinking the solution.
  • You may experience some abdominal bloating and distention before the bowels start to move. If severe discomfort or distention occur, stop drinking temporarily or drink each portion at longer intervals until the discomfort goes away.
  • Continue drinking until the watery stool is clear and free of solid matter. This usually requires 3 liters and it is best to drink all of the solution.
  • Do not take undissolved PEG-3350 and Electrolytes for Oral Solution powder that has not been mixed with water (diluted), it may increase your risk of nausea, vomiting and fluid loss (dehydration).Each jug of PEG-3350 and Electrolytes for Oral Solution must be reconstituted with water (diluted) to 4 liters total volume before drinking.
  • Do not take other laxatives while taking PEG-3350 and Electrolytes for Oral Solution.
  • Do not eat solid foods on the day before your colonoscopy and until after your colonoscopy. Drink only clear liquids:the day before your colonoscopy
  • While taking PEG-3350 and Electrolytes for Oral Solution
  • After taking PEG-3350 and Electrolytes for Oral Solution until 2 hours before your colonoscopy
  • Do not eat or drink anything 2 hours before your colonoscopy.Drink clear liquids before, during, and after you take PEG-3350 and Electrolytes for Oral Solution to avoid fluid loss (dehydrated). Examples of clear liquids are:water
  • Clear fruit juices without pulp including apple, white grape, or white cranberry
  • Strained limeade or lemonade
  • Coffee or tea (Do not use any dairy or non-dairy creamer)
  • Clear broth
  • Clear soda
  • Gelatin (without added fruit or topping)
  • Popsicles without pieces of fruit or fruit pulp
  • Do not eat or drink anything colored red or purple.What are the possible side effects of PEG-3350 and Electrolytes for Oral Solution?PEG-3350 and Electrolytes for Oral Solution can cause serious side effects, including:
  • See Section “What is the most important information I should know about PEG-3350 and Electrolytes for Oral Solution?”changes in certain blood tests.Your healthcare provider may do blood tests after you take PEG-3350 and Electrolytes for Oral Solution to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including:vomiting
  • Nausea
  • Bloating
  • Dizziness
  • Stomach (abdominal) cramping
  • Headache
  • Urinate less than usual
  • Trouble drinking clear liquid
  • Heart problems. PEG-3350 and Electrolytes for Oral Solution may cause irregular heartbeats.seizuresulcers of the bowel or bowel problems (ischemic colitis). Tell your healthcare provider right away if you have severe stomach-area (abdomen) pain or rectal bleeding.
  • The most common side effects of PEG-3350 and Electrolytes for Oral Solution include:
  • Nausea
  • Stomach (abdominal) fullness
  • Bloating
  • Stomach (abdominal) cramps
  • Vomiting
  • Anal irritation
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
  • These are not all the possible side effects of PEG-3350 and Electrolytes for Oral Solution. For more information, ask your healthcare provider or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store PEG-3350 and Electrolytes for Oral Solution?Store PEG-3350 and Electrolytes for Oral Solution at room temperature, between 59°F to 86°F (15°C to 30°C).
  • Keep PEG-3350 and Electrolytes for Oral Solution and all medicines out of the reach of children.General information about the safe and effective use of PEG-3350 and Electrolytes for Oral Solution.Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PEG-3350 and Electrolytes for Oral Solution for a condition for which it was not prescribed. Do not give PEG-3350 and Electrolytes for Oral Solution to other people, even if they are going to have the same procedure you are. It may harm them.
  • This Medication Guide summarizes important information about PEG-3350 and Electrolytes for Oral Solution. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for healthcare professionals.
  • For more information, go to www.affordablepharm.com or call 1-800-514-5617.
  • What are the ingredients in PEG-3350 and Electrolytes for Oral Solution?Active ingredients: polyethylene glycol 3350, sodium sulfate, sodium bicarbonate, sodium chloride, and potassium chloride.
  • Inactive ingredients: Pineapple Flavored PEG-3350 and Electrolytes for Oral Solution only (natural and artificial pineapple flavor powder, maltodextrin, gum arabic, sodium saccharin, silicon dioxide)
  • Affordable Pharmaceuticals, LLC
  • Braintree, MA 02185, USA
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Revised 9/2013

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