NDC 64380-766 Polyethylene Glycol 3350 And Electrolytes With Lemon Flavor

Polyethylene Glycol 3350 And Electrolytes With Lemon Flavor

NDC Product Code 64380-766

NDC Code: 64380-766

Proprietary Name: Polyethylene Glycol 3350 And Electrolytes With Lemon Flavor Additional informationCallout TooltipWhat 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 And Electrolytes With Lemon Flavor Additional informationCallout TooltipWhat 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.


Code Structure
  • 64380 - Strides Pharma Science Limited
    • 64380-766 - Polyethylene Glycol 3350 And Electrolytes With Lemon Flavor

NDC 64380-766-21

Package Description: 4 L in 1 JUG

NDC Product Information

Polyethylene Glycol 3350 And Electrolytes With Lemon Flavor with NDC 64380-766 is a a human prescription drug product labeled by Strides Pharma Science Limited. The generic name of Polyethylene Glycol 3350 And Electrolytes With Lemon Flavor is polyethylene glycol 3350 and electrolytes with lemon flavor. The product's dosage form is powder, for solution and is administered via oral form.

Labeler Name: Strides Pharma Science Limited

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 Additional informationCallout TooltipWhat 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.


Polyethylene Glycol 3350 And Electrolytes With Lemon Flavor Active Ingredient(s)

Additional informationCallout TooltipWhat 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)

Additional informationCallout TooltipWhat 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.

Pharmacological Class(es)

Additional informationCallout TooltipWhat 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)
  • 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Strides Pharma Science Limited
Labeler Code: 64380
FDA Application Number: ANDA204558 Additional informationCallout TooltipWhat 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: ANDA - A product marketed under an approved Abbreviated New Drug Application. Additional informationCallout TooltipWhat 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: 01-10-2019 Additional informationCallout TooltipWhat 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: 12-31-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Polyethylene Glycol 3350 And Electrolytes With Lemon Flavor Product Label Images

Polyethylene Glycol 3350 And Electrolytes With Lemon Flavor 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

Other

Polyethylene Glycol 3350 and electrolytes for oral solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults

For oral solution: A jug with powder for reconstitution with water to 4 liters.Each 5 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 (acesulfame potassium 0.2 g and flavor lemon 0.1 g for lemon flavor or acesulfame potassium 0.2 g and flavor orange 0.4 g for orange flavor). 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.

  • Polyethylene Glycol 3350 and electrolytes for oral solution, is contraindicated in the following conditions:Gastrointestinal (GI) obstruction, ileus, or gastric retentionBowel perforationToxic colitis or toxic megacolonKnown allergy or hypersensitivity to any component of Polyethylene Glycol 3350 and electrolytes for oral solution [see How Supplied/Storage and Handling (16) ]

The following adverse reactions have been identified during post-approval use of Polyethylene Glycol 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 Polyethylene Glycol 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

2.1 Dosage Overview

Polyethylene Glycol 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 Polyethylene Glycol 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. Besides these, the lemon flavored solution contain flavoring ingredients acesulfame potassium 0.2 grams and flavor lemon 0.1 gram while orange flavored solution contains acesulfame potassium 0.2grams and flavor orange 0.4grams respectively.

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 breakfastEarly in the evening prior to colonoscopy,fill the supplied container containing the Polyethylene Glycol 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 litersAfter 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 Polyethylene Glycol 3350 and electrolytes for oral 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 Polyethylene Glycol 3350 and electrolytes for oral solution,administration. Continue drinking until the watery stool is clear and free of solid matter

5.1 Serious Fluid And Serum Chemistry Abnormalities

Advise patients to hydrate adequately before, during, and after the use of Polyethylene Glycol 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 Polyethylene Glycol 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 Polyethylene Glycol 3350 and electrolytes for oral solution.In addition, use caution when prescribing Polyethylene Glycol 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 Polyethylene Glycol 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 Polyethylene Glycol 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 sected hyponatremia.

5.4 Renal Impairment

Use caution when prescribing Polyethylene Glycol 3350 and electrolytes for oral solution,  for patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs). 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 Polyethylene Glycol 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 sect inflammatory bowel disease (IBD).

5.6 Use In Patients With Significant Gastrointestinal Disease

If gastrointestinal obstruction or perforation is sected, perform appropriate diagnostic studies to rule out these conditions before administering Polyethylene Glycol 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 sected, appropriate studies should be performed to rule out these conditions before administration of Polyethylene Glycol 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 Polyethylene Glycol 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

7.1 Drugs That May Lead To Fluid And Electrolyte Abnormalities

Use caution when prescribing Polyethylene Glycol 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 Polyethylene Glycol 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 Polyethylene Glycol 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 Polyethylene Glycol 3350 and electrolytes for oral solution.

8.1 Pregnancy

Pregnancy Category CAnimal reproduction studies have not been conducted with Polyethylene Glycol 3350 and electrolytes for oral solution. It is also not known whether Polyethylene Glycol 3350 and electrolytes for oral solution, can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Polyethylene Glycol 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 Polyethylene Glycol 3350 and electrolytes for oral solution, is administered to a nursing woman.

8.4 Pediatric Use

Safety and effectiveness of Polyethylene Glycol 3350 and electrolytes for oral solution, in pediatric patients have not been established.

8.5 Geriatric Use

Clinical studies of Polyethylene Glycol 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 5 liter (5L) Polyethylene Glycol 3350 and electrolytes for oral solution, USP jug contains a white powder for reconstitution. Polyethylene Glycol 3350 and electrolytes for oral solution, USP is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution. Polyethylene Glycol 3350 and electrolytes for oral solution, USP is available in unflavored, lemon and orange flavors.Each 5 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. Besides these, the lemon flavored solution contain flavoring ingredients acesulfame potassium 0.2 grams and flavor lemon 0.1 gram while orange flavored solution contains acesulfame potassium 0.2 grams and flavor orange 0.4 grams respectively. The solution is clear and colorless when reconstituted to a final volume of 4 liters with water.Polyethylene Glycol 3350, NFSodium Sulfate, USPThe chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is:Sodium Bicarbonate, USPThe chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is:Sodium Chloride, USPThe chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is:Na+ Cl-Potassium Chloride, USPThe chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is:K-Climageimageimage

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

Polyethylene Glycol 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 Polyethylene Glycol 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 Polyethylene Glycol 3350 and electrolytes for oral solution. Studies to evaluate the possible impairment of fertility or mutagenic potential of Polyethylene Glycol 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 reconstitutionPolyethylene Glycol 3350 and electrolytes for oral solution, USP is available in a disposable jug in powdered form containing:Polyethylene Glycol 3350 and electrolytes for oral solution, USP : 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.Polyethylene Glycol 3350 and electrolytes for oral solution, USP with Lemon Flavor: 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, acesulfame potassium 0.2 g, flavor lemon 0.1 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.Polyethylene Glycol 3350 and electrolytes for oral solution, USP with Orange Flavor: 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, acesulfame potassium 0.2 g, flavor orange 0.4 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:Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see Controlled Room Temperature]. When reconstituted, keep solution refrigerated. Use within 48 hours. Discard unused portion.Keep out of reach of childrenPolyethylene Glycol 3350 and electrolytes for oral solution, USPNDC 64380-765-21Polyethylene Glycol 3350 and electrolytes for oral solution, USP with Lemon Flavor   NDC 64380-766-21Polyethylene Glycol 3350 and electrolytes for oral solution, USP with Orange Flavor  NDC64380-767-21

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 aspirationNot to take other laxatives while they are taking Polyethylene Glycol 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 colonoscopyThat 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 providerThat 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 physicianTo 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 Polyethylene Glycol 3350 and electrolytes for oral solution may be flushed from the GI tract and the medication may not be absorbed completelyManufactured by Strides Pharma Science Ltd, Bangalore-562106, IndiaDistributed by Strides Pharma Inc. East Brunswick

Spl Medguide

  • Medication GuidePOLYETHYLENE GLYCOL 3350 AND ELECTROLYTES FOR ORAL SOLUTION, USP(pol" ee eth' I leenglye' kol 3350)(PEG-3350 and Electrolytes for Oral Solution)Read this Medication Guide before you start taking Polyethylene Glycol 3350 and electrolytes for oral solution, USP. 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 Polyethylene Glycol 3350 and electrolytes for oral solution, USP?Polyethylene Glycol 3350 and electrolytes for oral solution, USP 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 seizurekidney problemsYour chance of having fluid loss and changes in body salts with Polyethylene Glycol 3350 and electrolytes for oral solution, USP is higher if you:have heart problemshave kidney problemstake 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 Polyethylene Glycol 3350 and electrolytes for oral solution, USP:vomiting that prevents you from keeping down the solutiondizzinessurinating less often than normalheadacheSee Section "What are the possible side effects of Polyethylene Glycol 3350 and electrolytes for oral solution, USP" for more information about side effects.What is Polyethylene Glycol 3350 and electrolytes for oral solution, USP?Polyethylene Glycol 3350 and electrolytes for oral solution, USP is a prescription medicine used by adults to clean the colon before a colonoscopy or barium enema X-ray examination. Polyethylene Glycol 3350 and electrolytes for oral solution, USP 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 Polyethylene Glycol 3350 and electrolytes for oral solution, USP is safe and effective in childrenWho should not take Polyethylene Glycol 3350 and electrolytes for oral solution, USP?Do not take Polyethylene Glycol 3350 and electrolytes for oral solution, USP 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 Polyethylene Glycol 3350 and electrolytes for oral solution, USP. See the end of this leaflet for a complete list of ingredients in Polyethylene Glycol 3350 and electrolytes for oral solution, USPWhat should I tell my healthcare provider before taking Polyethylene Glycol 3350 and electrolytes for oral solution, USP?Before you take Polyethylene Glycol 3350 and electrolytes for oral solution, USP, tell your healthcare provider if you:have heart problemshave stomach or bowel problemshave ulcerative colitishave problems with swallowing or gastric refluxhave a history of seizuresare withdrawing from drinking alcoholhave a low blood salt (sodium) levelhave kidney problemsany other medical conditionsare pregnant. It is not known if Polyethylene Glycol 3350 and electrolytes for oral solution, USP will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnantare breastfeeding or plan to breastfeed. It is not known if Polyethylene Glycol 3350 and electrolytes for oral solution, USP passes into your breast milk. You and your healthcare provider should decide if you will take Polyethylene Glycol 3350 and electrolytes for oral solution, USP while breastfeedingTell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Polyethylene Glycol 3350 and electrolytes for oral solution, USP may affect how other medicines work. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of Polyethylene Glycol 3350 and electrolytes for oral solution, USP. Especially tell your healthcare provider if you take:medicines for blood pressure or heart problemsmedicines for kidney problemsmedicines for seizureswater pills (diuretics)non-steroidal anti-inflammatory medicines (NSAID) pain medicineslaxativesAsk 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 aboveKnow the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicineHow should I take Polyethylene Glycol 3350 and electrolytes for oral solution, USP?You must read, understand, and follow these instructions to take Polyethylene Glycol 3350 and electrolytes for oral solution, USP the right way.Take Polyethylene Glycol 3350 and electrolytes for oral solution, USP exactly as your healthcare provider tells you to take itDrink 240 mL (8 oz.) every 10 minutes. Rapid drinking of each portion is better than drinking small amountsThe first bowel movement should occur approximately one hour after you start drinking the solutionYou 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 awayContinue 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 solutionDo not take undissolved Polyethylene Glycol 3350 and electrolytes for oral solution, USP powder that has not been mixed with water (diluted), it may increase your risk of nausea, vomiting and fluid loss (dehydration).Each jug of Polyethylene Glycol 3350 and electrolytes for oral solution, USP must be reconstituted with water (diluted) to 4 liters total volume before drinkingDo not take other laxatives while taking Polyethylene Glycol 3350 and electrolytes for oral solution, USP.Do not eat solid foods on the day before your colonoscopy and until after your colonoscopy. Drink only clear liquids:the day before your colonoscopywhile taking Polyethylene Glycol 3350 and electrolytes for oral solution, USPafter taking Polyethylene Glycol 3350 and electrolytes for oral solution, USP until 2 hours before your colonoscopyDo not eat or drink anything 2 hours before your colonoscopy.Drink clear liquids before, during, and after you take Polyethylene Glycol 3350 and electrolytes for oral solution, USP to avoid fluid loss (dehydrated). Examples of clear liquids are:waterclear fruit juices without pulp including apple, white grape, or white cranberrystrained limeade or lemonadecoffee or tea (Do not use any dairy or non-dairy creamer)clear brothclear sodagelatin (without added fruit or topping)popsicles without pieces of fruit or fruit pulpDo not eat or drink anything colored red or purple.What are the possible side effects of Polyethylene Glycol 3350 and electrolytes for oral solution, USP?Polyethylene Glycol 3350 and electrolytes for oral solution, USP can cause serious side effects, including:See Section "What is the most important information I should know about Polyethylene Glycol 3350 and electrolytes for oral solution, USP?"changes in certain blood tests. Your healthcare provider may do blood tests after you take Polyethylene Glycol 3350 and electrolytes for oral solution, USP to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including:vomitingnauseabloatingdizzinessstomach (abdominal) crampingheadacheurinate less than usualtrouble drinking clear liquidheart problems. Polyethylene Glycol 3350 and electrolytes for oral solution, USP 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 bleedingThe most common side effects of Polyethylene Glycol 3350 and electrolytes for oral solution, USP include:nauseastomach (abdominal) fullnessbloatingstomach (abdominal) crampsvomitinganal irritationTell your healthcare provider if you have any side effect that bothers you or that does not go awayThese are not all the possible side effects of Polyethylene Glycol 3350 and electrolytes for oral solution, USP. For more information, ask your healthcare provider or pharmacistCall your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088How should I store Polyethylene Glycol 3350 and electrolytes for oral solution, USP?Store Polyethylene Glycol 3350 and electrolytes for oral solution, USP at room temperature, between 59°F to 86°F (15°C to 30°C).Keep Polyethylene Glycol 3350 and electrolytes for oral solution, USPand all medicines out of the reach of children.General information about the safe and effective use of Polyethylene Glycol 3350 and electrolytes for oral solution, USP.Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Polyethylene Glycol 3350 and electrolytes for oral solution, USPfor a condition for which it was not prescribed. Do not give Polyethylene Glycol 3350 and electrolytes for oral solution, USPto other people, even if they are going to have the same procedure you are. It may harm themThis Medication Guide summarizes important information about Polyethylene Glycol 3350 and electrolytes for oral solution, USP. 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 professionalsFor more information, go to www.stridesshasun.com or call 1-877-244-9825.What are the ingredients in Polyethylene Glycol 3350 and electrolytes for oral solution, USP?Active ingredients: polyethylene glycol 3350, sodium sulfate, sodium bicarbonate, sodium chloride, and potassium chlorideInactive ingredients:Lemon and Orange Flavored Polyethylene Glycol 3350 and electrolytes for oral solution, USP only (acesulfame potassium, natural orange flavor powder, natural flavor lemon powder)Manufactured by Strides Pharma Science Ltd., Bengaluru-562106, IndiaDistributed by Strides Pharma Inc. East Brunswick Revised 12/2018

* Please review the disclaimer below.

Previous Code
64380-765
Next Code
64380-767