ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Nausea, abdominal bloating, cramping and flatulence may occur. High doses may producediarrhea and excessive stool frequency, particularly in elderly nursing home patients.Patients taking other medications containing polyethylene glycol have occasionallydeveloped urticaria suggestive of an allergic reaction.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

Carcinogenesis, mutagenesis, impairment of fertility. Long term carcinogenicity studies,genetic toxicity studies or reproductive toxicity studies in animals have not been performedwith Polyethylene Glycol 3350 NF.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. Pharmacology: Polyethylene Glycol 3350 NF is an osmotic agent which causes water to beretained with the stool. Essentially, complete recovery of Polyethylene Glycol 3350 NF wasshown in normal subjects without constipation. Attempts at recovery of Polyethylene Glycol3350 NF in constipated patients resulted in incomplete and highly variable recovery. In vitrostudy showed indirectly that Polyethylene Glycol 3350 NF was not fermented into hydrogenor methane by the colonic microflora in human feces. Polyethylene Glycol 3350 NF appearsto have no effect on the active absorption or secretion of glucose or electrolytes. There is noevidence of tachyphylaxis.CLINICAL TRIALSIn one study, patients with less than bowel movements per week were randomized toPolyethylene Glycol 3350 NF, 17 grams, or placebo for 14 days. An increase in bowelmovement frequency was observed for both treatment groups during the first week oftreatment. Polyethylene Glycol 3350 NF was statistically superior to placebo during thesecond week of treatment. In another study, patients with bowel movements or less perweek and/or less than 300 grams of stool per week were randomized to dose levels ofPolyethylene Glycol 3350 NF or placebo for 10 days each. Success was defined by anincrease in both bowel movement frequency and daily stool weight. For both parameters,superiority of the 17 gram dose of Polyethylene Glycol 3350 NF over placebo wasdemonstrated.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. Polyethylene Glycol 3350 NF is contraindicated in patients with known or suspected bowelobstruction and patients known to be allergic to polyethylene glycol.

DESCRIPTION SECTION.

DESCRIPTION. white powder for reconstitution. Polyethylene Glycol 3350 NF (Polyethylene Glycol 3350Powder For Oral Solution) is synthetic polyglycol having an average molecular weight of3350. The actual molecular weight is not less than 90.0 percent and not greater than 110.0percent of the nominal value. The chemical formula is HO(C2H4O)nH in which representsthe average number of oxyethylene groups. Below 55C it is free flowing white powderfreely soluble in water. Polyethylene Glycol 3350 NF is an osmotic agent for the treatmentof constipation.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. The usual dose is 17 grams (about heaping tablespoon) of powder per day (or as directedby physician) in to ounces of water, juice, soda, coffee, or tea. Each bottle ofPolyethylene Glycol 3350 NF is supplied with dosing cup marked to contain 17 grams oflaxative powder when filled to the indicated line. Two to days (48 to 96 hours) may berequired to produce bowel movement.

DRUG ABUSE AND DEPENDENCE SECTION.

DRUG ABUSE AND DEPENDENCE. Overdosage. There have been no reports of accidental overdosage. In the event of overdosage, diarrheawould be the expected major event. If an overdose of drug occurred without concomitantingestion of fluid, dehydration due to diarrhea may result. Medication should be terminatedand free water administered. The oral LD50 is 50 gm/kg in mice, rats and rabbits.

DRUG INTERACTIONS SECTION.

Drug interactions. No specific drug interactions have been demonstrated.

GENERAL PRECAUTIONS SECTION.

General. Patients presenting with complaints of constipation should have thoroughmedical history and physical examination to detect associated metabolic, endocrine andneurogenic conditions and medications. diagnostic evaluation should include structuralexamination of the colon. Patients should be educated about good defecatory and eatinghabits (such as high fiber diets) and lifestyle changes (adequate dietary fiber and fluidintake, regular exercise) which may produce more regular bowel habits.Polyethylene Glycol 3350 NF should be administered after being dissolved in approximately4 to ounces of water, juice, soda, coffee or tea.

GERIATRIC USE SECTION.

Geriatric use. There is no evidence for special considerations when Polyethylene Glycol3350 NF is administered to elderly patients. In geriatric nursing home patients higherincidence of diarrhea occurred at the recommended 17 dose. If diarrhea occursPolyethylene Glycol 3350 NF should be discontinued.

HOW SUPPLIED SECTION.

HOW SUPPLIED. In powdered form, for oral administration after dissolution in water, juice, soda, coffee, ortea. Polyethylene Glycol 3350 NF (Polyethylene Glycol 3350 Powder for Oral Solution) isavailable in two package sizes: 500 cc container of 255 grams of laxative powder and a950 cc container of 527 grams of laxative powder.NDC 0722-6920-01 Polyethylene Glycol 3350 NF 255gNDC 0722-6921-01 Polyethylene Glycol 3350 NF 527gThe dosing cup supplied with each bottle is marked with measuring line and may be used tomeasure single Polyethylene Glycol 3350 NF dose of 17 grams (about heaping tablespoonful).Rx onlyKeep this and all medications out of the reach of children.STORAGEStore at 20- 25C (68- 77F); excursions permitted to 15 30C (59 86F).[See USP Controlled Room Temperature]Manufactured by:Nexgen Pharma, Inc.Irvine, CA 92614Distributed by:Breckenridge Pharmaceutical, Inc.Boca Raton, FL 334876920, 6921 Rev 11/08.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. For the treatment of occasional constipation. This product should be used for weeks orless or as directed by physician.

INFORMATION FOR PATIENTS SECTION.

Information for patients. Polyethylene Glycol 3350 NF softens the stool and increases thefrequency of bowel movements by retaining water in the stool. It should always be taken bymouth after being dissolved in to ounces of water, juice, soda, coffee, or tea. Shouldunusual cramps, bloating, or diarrhea occur, consult your physician.Two to days may be required to produce bowel movement. This product should be usedfor weeks or less or as directed by your physician. Prolonged, frequent or excessive use ofPolyethylene Glycol 3350 NF may result in electrolyte imbalance and dependence on laxatives.

LABORATORY TESTS SECTION.

Laboratory tests. No clinically significant effects on laboratory tests have been demonstrated.

OVERDOSAGE SECTION.

Overdosage. There have been no reports of accidental overdosage. In the event of overdosage, diarrheawould be the expected major event. If an overdose of drug occurred without concomitantingestion of fluid, dehydration due to diarrhea may result. Medication should be terminatedand free water administered. The oral LD50 is 50 gm/kg in mice, rats and rabbits.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL. 255 gram Principal Display Panel.

PEDIATRIC USE SECTION.

Pediatric use. Safety and effectiveness in pediatric patients has not been established.

PRECAUTIONS SECTION.

PRECAUTIONS. General. Patients presenting with complaints of constipation should have thoroughmedical history and physical examination to detect associated metabolic, endocrine andneurogenic conditions and medications. diagnostic evaluation should include structuralexamination of the colon. Patients should be educated about good defecatory and eatinghabits (such as high fiber diets) and lifestyle changes (adequate dietary fiber and fluidintake, regular exercise) which may produce more regular bowel habits.Polyethylene Glycol 3350 NF should be administered after being dissolved in approximately4 to ounces of water, juice, soda, coffee or tea.. Information for patients. Polyethylene Glycol 3350 NF softens the stool and increases thefrequency of bowel movements by retaining water in the stool. It should always be taken bymouth after being dissolved in to ounces of water, juice, soda, coffee, or tea. Shouldunusual cramps, bloating, or diarrhea occur, consult your physician.Two to days may be required to produce bowel movement. This product should be usedfor weeks or less or as directed by your physician. Prolonged, frequent or excessive use ofPolyethylene Glycol 3350 NF may result in electrolyte imbalance and dependence on laxatives.. Laboratory tests. No clinically significant effects on laboratory tests have been demonstrated.. Interactions. Drug interactions. No specific drug interactions have been demonstrated.. Carcinogenesis, mutagenesis, impairment of fertility. Long term carcinogenicity studies,genetic toxicity studies or reproductive toxicity studies in animals have not been performedwith Polyethylene Glycol 3350 NF.. Pregnancy. Category C. Animal reproductive studies have not been performed with Polyethylene Glycol 3350 NF.It is also not known whether Polyethylene Glycol 3350 NF can cause fetal harm whenadministered to pregnant woman, or can affect reproductive capacity. Polyethylene Glycol3350 NF should only be administered to pregnant woman if clearly needed.. Pediatric use. Safety and effectiveness in pediatric patients has not been established.. Geriatric use. There is no evidence for special considerations when Polyethylene Glycol3350 NF is administered to elderly patients. In geriatric nursing home patients higherincidence of diarrhea occurred at the recommended 17 dose. If diarrhea occursPolyethylene Glycol 3350 NF should be discontinued.

PREGNANCY SECTION.

Pregnancy. Category C. Animal reproductive studies have not been performed with Polyethylene Glycol 3350 NF.It is also not known whether Polyethylene Glycol 3350 NF can cause fetal harm whenadministered to pregnant woman, or can affect reproductive capacity. Polyethylene Glycol3350 NF should only be administered to pregnant woman if clearly needed.

SPL PATIENT PACKAGE INSERT SECTION.

PATIENT INFORMATION. PATIENT INFORMATIONPolyethylene Glycol 3350 NF (Polyethylene Glycol 3350 Powder for Oral Solution) is aprescription only laxative which has been prescribed by your physician to treat constipation.This product should only be used by the person for whom it was prescribed.How to takeThe dose is 17 grams each day or as directed by physician. It should always be taken by mouth.Measure the dose using the dosing cup (or use one heaping tablespoon of powder), stir anddissolve in glass (4 to oz) of water, juice, soda, coffee, or tea. Taking more than theprescribed dose may cause loss of fluid due to severe diarrhea.How will it workPolyethylene Glycol 3350 NF softens the stool and increases the frequency of bowelmovements by retaining water in the stool. Your first bowel movement will usually happen intwo to four days, although results may vary for individual patients.How long should take itPolyethylene Glycol 3350 NF achieves its best results when used between one and two weeks.You may discontinue taking the drug after you had several satisfactory bowel movements.Should unusual cramps, bloating, or diarrhea occur, consult your physician. PolyethyleneGlycol 3350 NF is intended for up to two week course of therapy. You should not use for alonger time unless directed by your physician.Next StepsAfter successfully completing Polyethylene Glycol 3350 NF therapy (usually between one andtwo weeks), please discuss with your physician lifestyle changes which may produce moreregular bowel habits (adequate dietary and fluid intake, regular exercise).Who should NOT take Polyethylene Glycol 3350 NFPolyethylene Glycol 3350 NF should not be used by children. It should not be used by pregnantwomen unless prescribed by physician.Side Effects/Drug ReactionsOccasionally, Polyethylene Glycol 3350 NF may cause nausea, stomach fullness, cramping,diarrhea and/or gas. Do not take if you have symptoms such as nausea, vomiting, abdominalpain or distention, which may be due to bowel obstruction. On rare occasions hives and skinrashes have been reported which are suggestive of an allergic reaction. If you get an allergicreaction you should discontinue the medication and call your physician. If you are allergic topolyethylene glycol, do not use this drug.

SPL UNCLASSIFIED SECTION.

Interactions. Drug interactions. No specific drug interactions have been demonstrated.

WARNINGS SECTION.

WARNINGS. Patients with symptoms suggestive of bowel obstruction (nausea, vomiting, abdominalpain or distention) should be evaluated to rule out this condition before initiatingPolyethylene Glycol 3350 NF therapy.