• • • • • • • • • •

Schwarz Pharma L4556A Glycolax Powder Pouch 2.5'' x 6'' BLACK PMS 2597 DIELINE DOES NOT PRINT

Schwarz Pharma PCL4554 base 100% 8.0625'' x 3'' BLACK PMS 2597 PMS 877P

CL4

554

Laboratory Tests:No clinically significant effects onlaboratory tests have been demonstrated.

Drug Interactions:No specific drug interactions havebeen demonstrated.

Carcinogenesis, Mutagenesis, Impairment of Fertility:Long-term carcinogenicity studies, genetic toxicitystudies and reproductive toxicity studies in animalshave not been performed with GlycoLax™.

Pregnancy:Category C. Animal reproductive studieshave not been performed with GlycoLax™. It is also notknown whether GlycoLax™ can cause fetal harm whenadministered to a pregnant woman, or can affect repro-ductive capacity. GlycoLax™ should only be adminis-tered to a pregnant woman if clearly needed.

Pediatric Use:Safety and effectiveness in pediatricpatients has not been established.

Geriatric Use:There is no evidence for special consid-erations when GlycoLax™ is administered to elderlypatients.

In geriatric nursing home patients, a higher incidenceof diarrhea occurred at the recommended 17 gramdose. If diarrhea occurs, GlycoLax™ should be discon-tinued.

ADVERSE REACTIONS Nausea, abdominal bloating, cramping and flatulencemay occur. High doses may produce diarrhea andexcessive stool frequency, particularly in elderly nurs-ing home patients.

Patients taking other medications containing polyethyl-ene glycol have occasionally developed urticaria sug-gestive of an allergic reaction.

OVERDOSAGE There have been no reports of accidental overdosage.In the event of overdosage, diarrhea would be theexpected major event. If an overdose of drug occurredwithout concomitant ingestion of fluid, dehydration dueto diarrhea may result. Medication should be terminat-ed and free water administered. The oral LD50is >50gm/kg in mice, rats and rabbits.

DOSAGE AND ADMINISTRATION The usual dose is 17 grams (about 1 heaping table-spoon) of powder per day (or as directed by physician)in 8 ounces of water, juice, soda, coffee, or tea. Eachbottle of GlycoLax™ is supplied with a dosing cupmarked to contain 17 grams of laxative powder whenfilled to the indicated line.

Two to 4 days (48 to 96 hours) may be required toproduce a bowel movement.

HOW SUPPLIED In powdered form, for oral administration after dissolu-tion in water, juice, soda, coffee, or tea. GlycoLax™(Polyethylene Glycol 3350 Powder for Oral Solution) isavailable in three package sizes: a 16 oz. container of255 grams of laxative powder (NDC 62175-442-15), a24 oz. container of 527 grams of laxative powder (NDC62175-442-31), and a carton of 14 individual packetscontaining a single 17 gram dose (NDC 62175-442-14).

The dosing cup supplied with each bottle is markedwith a measuring line and may be used to measure asingle GlycoLax™ dose of 17 grams (about 1 heapingtablespoon).

Each individual packet contains a single GlycoLax™dose of 17 grams (about 1 heaping tablespoon).

Store at 20°- 25°C (68°- 77°F); excursions permittedbetween 15°- 30°C (59°- 86°F) [See USP ControlledRoom Temperature].

Kremers Urban, Inc.Mequon, WI 53092, USA

PCL4554Rev. 10/02

PATIENT INFORMATION

GlycoLax™ (Polyethylene Glycol 3350 Powder for OralSolution) is a prescription only laxative which has beenprescribed by your physician to treat constipation. Thisproduct should only be used by the person for whom itwas prescribed.

How to takeThe dose is 17 grams each day or as directed by physi-cian. It should always be taken by mouth. Measure thedose using the dosing cup (or use one heaping tablespoonof powder), stir and dissolve in a glass (8 oz) of water,juice, soda, coffee, or tea. Taking more than the prescribeddose may cause loss of fluid due to severe diarrhea.

How will it workGlycoLax™ softens the stool and increases the frequencyof bowel movements by retaining water in the stool. Yourfirst bowel movement will usually happen in two to fourdays, although results may vary for individual patients.

How long should I take itGlycoLax™ achieves its best results when used betweenone and two weeks. You may discontinue taking the drugafter you have had several satisfactory bowel movements.Should unusual cramps, bloating, or diarrhea occur, con-sult your physician. GlycoLax™ is intended for up to a twoweek course of therapy. You should not use for a longertime unless directed by your physician.

Next StepsAfter successfully completing the GlycoLax™ therapy(usually between one and two weeks), please discuss withyour physician lifestyle changes which may produce moreregular bowel habits (adequate dietary and fluid intake,regular exercise).

Who Should NOT take GlycoLax™GlycoLax™ should not be used by children. It should not beused by pregnant women unless prescribed by a physician.

Side Effects/Drug ReactionsOccasionally, GlycoLax™ may cause nausea, stomach full-ness, cramping, diarrhea and/or gas. Do not take if youhave symptoms such as nausea, vomiting, abdominal painor distention, which may be due to bowel obstruction. Onrare occasions, hives and skin rashes have been reportedwhich are suggestive of an allergic reaction. If you get anallergic reaction, you should discontinue the medicationand call your physician.

If you are allergic to polyethylene glycol, do not use thisdrug.

Kremers Urban, Inc.Mequon, WI 53092, USA

GlycoLax™(Polyethylene Glycol 3350 Powder for Oral Solution)

Rx Only

DESCRIPTION A white powder for reconstitution. GlycoLax™(Polyethylene Glycol 3350 Powder for Oral Solution) isa synthetic polyglycol having an average molecularweight of 3350. The actual molecular weight is not lessthan 90.0 percent and not greater than 110.0 percentof the nominal value. The chemical formula isHO(C2H4O)nH in which n represents the average num-ber of oxyethylene groups. Below 55°C, it is a freeflowing white powder freely soluble in water.GlycoLax™ is an osmotic agent for the treatment ofconstipation.

CLINICAL PHARMACOLOGY Pharmacology: GlycoLax™ is an osmotic agent whichcauses water to be retained with the stool. Essentially,complete recovery of GlycoLax™ was shown in normalsubjects without constipation. Attempts at recovery ofGlycoLax™ in constipated patients resulted in incom-plete and highly variable recovery. In vitro studyshowed indirectly that GlycoLax™ was not fermentedinto hydrogen or methane by the colonic microflora inhuman feces. GlycoLax™ appears to have no effect onthe active absorption or secretion of glucose or elec-trolytes. There is no evidence of tachyphylaxis.

CLINICAL TRIALSIn one study, patients with less than 3 bowel move-ments per week were randomized to GlycoLax™, 17grams, or placebo for 14 days. An increase in bowelmovement frequency was observed for both treatmentgroups during the first week of treatment. GlycoLax™was statistically superior to placebo during the secondweek of treatment.

In another study, patients with 3 bowel movements orless per week and/or less than 300 grams of stool perweek were randomized to 2 dose levels of GlycoLax™or placebo for 10 days each. Success was defined byan increase in both bowel movement frequency anddaily stool weight. For both parameters, superiority ofthe 17 gram dose of GlycoLax™ over placebo wasdemonstrated.

INDICATIONS AND USAGE For the treatment of occasional constipation. Thisproduct should be used for 2 weeks or less or asdirected by a physician.

CONTRAINDICATIONS GlycoLax™ is contraindicated in patients with known orsuspected bowel obstruction and patients known to beallergic to polyethylene glycol.

WARNINGS Patients with symptoms suggestive of bowel obstruc-tion (nausea, vomiting, abdominal pain or distention)should be evaluated to rule out this condition beforeinitiating GlycoLax™ therapy.

PRECAUTIONS General: Patients presenting with complaints of consti-pation should have a thorough medical history andphysical examination to detect associated metabolic,endocrine and neurogenic conditions, and medications.A diagnostic evaluation should include a structuralexamination of the colon. Patients should be educatedabout good defecatory and eating habits (such as highfiber diets) and lifestyle changes (adequate dietary fiberand fluid intake, regular exercise) which may producemore regular bowel habits.

GlycoLax™ should be administered after being dis-solved in approximately 8 ounces of water, juice, soda,coffee, or tea.

Information for Patients: GlycoLax™ softens the stooland increases the frequency of bowel movements byretaining water in the stool. It should always be takenby mouth after being dissolved in 8 ounces of water,juice, soda, coffee, or tea. Should unusual cramps,bloating, or diarrhea occur, consult your physician.

Two to 4 days may be required to produce a bowelmovement. This product should be used for 2 weeks orless or as directed by a physician. Prolonged, frequentor excessive use of GlycoLax™ may result in electrolyteimbalance and dependence on laxatives.

Schwarz Pharma PCL4554 100% 3'' x 20.125'' (folded size 3.4375'' x 3'') BLACK PMS 2597 PMS 877

Schwarz Pharma PCL4554A Base 100% 8.0625'' x 3'' BLACK PMS 2597 PMS 877

Laboratory Tests:No clinically significant effects onlaboratory tests have been demonstrated.

Drug Interactions:No specific drug interactions havebeen demonstrated.

Carcinogenesis, Mutagenesis, Impairment of Fertility:Long-term carcinogenicity studies, genetic toxicitystudies and reproductive toxicity studies in animalshave not been performed with GlycoLax™.

Pregnancy:Category C. Animal reproductive studieshave not been performed with GlycoLax™. It is also notknown whether GlycoLax™ can cause fetal harm whenadministered to a pregnant woman, or can affect repro-ductive capacity. GlycoLax™ should only be adminis-tered to a pregnant woman if clearly needed.

Pediatric Use:Safety and effectiveness in pediatricpatients has not been established.

Geriatric Use:There is no evidence for special consid-erations when GlycoLax™ is administered to elderlypatients.

In geriatric nursing home patients, a higher incidenceof diarrhea occurred at the recommended 17 gramdose. If diarrhea occurs, GlycoLax™ should be discon-tinued.

ADVERSE REACTIONS Nausea, abdominal bloating, cramping and flatulencemay occur. High doses may produce diarrhea andexcessive stool frequency, particularly in elderly nurs-ing home patients.

Patients taking other medications containing polyethyl-ene glycol have occasionally developed urticaria sug-gestive of an allergic reaction.

OVERDOSAGE There have been no reports of accidental overdosage.In the event of overdosage, diarrhea would be theexpected major event. If an overdose of drug occurredwithout concomitant ingestion of fluid, dehydration dueto diarrhea may result. Medication should be terminat-ed and free water administered. The oral LD50is >50gm/kg in mice, rats and rabbits.

DOSAGE AND ADMINISTRATION The usual dose is 17 grams (about 1 heaping table-spoonful) of powder per day (or as directed by physi-cian) in 8 ounces of water, juice, soda, coffee, or tea.Each bottle of GlycoLax™ is supplied with a dosing cupmarked to contain 17 grams of laxative powder whenfilled to the indicated line.

Two to 4 days (48 to 96 hours) may be required toproduce a bowel movement.

HOW SUPPLIED In powdered form, for oral administration after dissolu-tion in water, juice, soda, coffee, or tea. GlycoLax™(Polyethylene Glycol 3350 Powder for Oral Solution) isavailable in three package sizes: a 16 oz. container of255 grams of laxative powder (NDC 62175-442-15), a24 oz. container of 527 grams of laxative powder (NDC62175-442-31), and a carton of 14 individual packetscontaining a single 17 gram dose (NDC 62175-442-14).

The dosing cup supplied with each bottle is markedwith a measuring line and may be used to measure asingle GlycoLax™ dose of 17 grams (about 1 heapingtablespoonful).

Each individual packet contains a single GlycoLax™dose of 17 grams (about 1 heaping tablespoonful).

Store at 20°- 25°C (68°- 77°F); excursions permittedbetween 15°- 30°C (59°- 86°F) [See USP ControlledRoom Temperature].

Kremers Urban, LLCMequon, WI 53092, USA

PCL4554ARev. 03/04

PATIENT INFORMATION

GlycoLax™ (Polyethylene Glycol 3350 Powder for OralSolution) is a prescription only laxative which has beenprescribed by your physician to treat constipation. Thisproduct should only be used by the person for whom itwas prescribed.

How to takeThe dose is 17 grams each day or as directed by physician.It should always be taken by mouth. Measure the doseusing the dosing cup (or use one heaping tablespoonful ofpowder), stir and dissolve in a glass (8 oz) of water, juice,soda, coffee, or tea. Taking more than the prescribed dosemay cause loss of fluid due to severe diarrhea.

How will it workGlycoLax™ softens the stool and increases the frequencyof bowel movements by retaining water in the stool. Yourfirst bowel movement will usually happen in two to fourdays, although results may vary for individual patients.

How long should I take itGlycoLax™ achieves its best results when used betweenone and two weeks. You may discontinue taking the drugafter you have had several satisfactory bowel movements.Should unusual cramps, bloating, or diarrhea occur, con-sult your physician. GlycoLax™ is intended for up to a twoweek course of therapy. You should not use for a longertime unless directed by your physician.

Next StepsAfter successfully completing the GlycoLax™ therapy(usually between one and two weeks), please discuss withyour physician lifestyle changes which may produce moreregular bowel habits (adequate dietary and fluid intake,regular exercise).

Who Should NOT take GlycoLax™GlycoLax™ should not be used by children. It should not beused by pregnant women unless prescribed by a physician.

Side Effects/Drug ReactionsOccasionally, GlycoLax™ may cause nausea, stomach full-ness, cramping, diarrhea and/or gas. Do not take if youhave symptoms such as nausea, vomiting, abdominal painor distention, which may be due to bowel obstruction. Onrare occasions, hives and skin rashes have been reportedwhich are suggestive of an allergic reaction. If you get anallergic reaction, you should discontinue the medicationand call your physician.

If you are allergic to polyethylene glycol, do not use thisdrug product.

Kremers Urban, LLCMequon, WI 53092, USA

GlycoLax™(Polyethylene Glycol 3350 Powder for Oral Solution)

Rx Only

DESCRIPTION A white powder for reconstitution. GlycoLax™(Polyethylene Glycol 3350 Powder for Oral Solution) isa synthetic polyglycol having an average molecularweight of 3350. The actual molecular weight is not lessthan 90.0 percent and not greater than 110.0 percentof the nominal value. The chemical formula isHO(C2H4O)nH in which n represents the average num-ber of oxyethylene groups. Below 55°C, it is a freeflowing white powder freely soluble in water.GlycoLax™ is an osmotic agent for the treatment ofconstipation.

CLINICAL PHARMACOLOGY Pharmacology: GlycoLax™ is an osmotic agent whichcauses water to be retained with the stool. Essentially,complete recovery of GlycoLax™ was shown in normalsubjects without constipation. Attempts at recovery ofGlycoLax™ in constipated patients resulted in incom-plete and highly variable recovery. In vitro studyshowed indirectly that GlycoLax™ was not fermentedinto hydrogen or methane by the colonic microflora inhuman feces. GlycoLax™ appears to have no effect onthe active absorption or secretion of glucose or elec-trolytes. There is no evidence of tachyphylaxis.

CLINICAL TRIALSIn one study, patients with less than 3 bowel move-ments per week were randomized to GlycoLax™, 17grams, or placebo for 14 days. An increase in bowelmovement frequency was observed for both treatmentgroups during the first week of treatment. GlycoLax™was statistically superior to placebo during the secondweek of treatment.

In another study, patients with 3 bowel movements orless per week and/or less than 300 grams of stool perweek were randomized to 2 dose levels of GlycoLax™or placebo for 10 days each. Success was defined byan increase in both bowel movement frequency anddaily stool weight. For both parameters, superiority ofthe 17 gram dose of GlycoLax™ over placebo wasdemonstrated.

INDICATIONS AND USAGE For the treatment of occasional constipation. Thisproduct should be used for 2 weeks or less or asdirected by a physician.

CONTRAINDICATIONS GlycoLax™ is contraindicated in patients with known orsuspected bowel obstruction and patients known to beallergic to polyethylene glycol.

WARNINGS Patients with symptoms suggestive of bowel obstruc-tion (nausea, vomiting, abdominal pain or distention)should be evaluated to rule out this condition beforeinitiating GlycoLax™ therapy.

PRECAUTIONS General: Patients presenting with complaints of consti-pation should have a thorough medical history andphysical examination to detect associated metabolic,endocrine and neurogenic conditions, and medications.A diagnostic evaluation should include a structuralexamination of the colon. Patients should be educatedabout good defecatory and eating habits (such as highfiber diets) and lifestyle changes (adequate dietary fiberand fluid intake, regular exercise) which may producemore regular bowel habits.

GlycoLax™ should be administered after being dis-solved in approximately 8 ounces of water, juice, soda,coffee, or tea.

Information for Patients: GlycoLax™ softens the stooland increases the frequency of bowel movements byretaining water in the stool. It should always be takenby mouth after being dissolved in 8 ounces of water,juice, soda, coffee, or tea. Should unusual cramps,bloating, or diarrhea occur, consult your physician.

Two to 4 days may be required to produce a bowelmovement. This product should be used for 2 weeks orless or as directed by a physician. Prolonged, frequentor excessive use of GlycoLax™ may result in electrolyteimbalance and dependence on laxatives.

Schwarz Pharma PCL4554A 100% 3'' x 20.125'' (folded size 3.4375'' x 3'') BLACK PMS 2597 PMS 877

Schwarz Pharma PCL4555 base 100% 8.0625'' x 4'' BLACK PMS 2597 PMS 877

PC

L4

555

Laboratory Tests:No clinically significant effects on laboratory tests havebeen demonstrated.

Drug Interactions:No specific drug interactions have been demonstrated.

Carcinogenesis, Mutagenesis, Impairment of Fertility:Long-term carcino-genicity studies, genetic toxicity studies and reproductive toxicity studies inanimals have not been performed with GlycoLax™.

Pregnancy:Category C. Animal reproductive studies have not been per-formed with GlycoLax™. It is also not known whether GlycoLax™ cancause fetal harm when administered to a pregnant woman, or can affectreproductive capacity. GlycoLax™ should only be administered to a preg-nant woman if clearly needed.

Pediatric Use:Safety and effectiveness in pediatric patients has not beenestablished.

Geriatric Use:There is no evidence for special considerations whenGlycoLax™ is administered to elderly patients.

In geriatric nursing home patients, a higher incidence of diarrhea occurredat the recommended 17 gram dose. If diarrhea occurs, GlycoLax™ shouldbe discontinued.

ADVERSE REACTIONS Nausea, abdominal bloating, cramping and flatulence may occur. Highdoses may produce diarrhea and excessive stool frequency, particularly inelderly nursing home patients.

Patients taking other medications containing polyethylene glycol have occa-sionally developed urticaria suggestive of an allergic reaction.

OVERDOSAGE There have been no reports of accidental overdosage. In the event of over-dosage, diarrhea would be the expected major event. If an overdose ofdrug occurred without concomitant ingestion of fluid, dehydration due todiarrhea may result. Medication should be terminated and free wateradministered. The oral LD50is >50 gm/kg in mice, rats and rabbits.

DOSAGE AND ADMINISTRATION The usual dose is 17 grams (about 1 heaping tablespoon) of powder perday (or as directed by physician) in 8 ounces of water, juice, soda, coffee,or tea. Each bottle of GlycoLax™ is supplied with a dosing cup marked tocontain 17 grams of laxative powder when filled to the indicated line.

Two to 4 days (48 to 96 hours) may be required to produce a bowel move-ment.

HOW SUPPLIED In powdered form, for oral administration after dissolution in water, juice,soda, coffee, or tea. GlycoLax™ (Polyethylene Glycol 3350 Powder for OralSolution) is available in three package sizes: a 16 oz. container of 255grams of laxative powder (NDC 62175-442-15), a 24 oz. container of 527grams of laxative powder (NDC 62175-442-31), and a carton of 14 individ-ual packets containing a single 17 gram dose (NDC 62175-442-14).

The dosing cup supplied with each bottle is marked with a measuring lineand may be used to measure a single GlycoLax™ dose of 17 grams (about1 heaping tablespoon).

Each individual packet contains a single GlycoLax™ dose of 17 grams(about 1 heaping tablespoon).

Store at 20°- 25°C (68°- 77°F); excursions permitted between 15°- 30°C(59°- 86°F) [See USP Controlled Room Temperature].

Kremers Urban, Inc.Mequon, WI 53092, USA

PCL4555Rev. 10/02

PATIENT INFORMATION

GlycoLax™ (Polyethylene Glycol 3350 Powder for Oral Solution) is a pre-scription only laxative which has been prescribed by your physician to treatconstipation. This product should only be used by the person for whom itwas prescribed.

How to takeThe dose is 17 grams each day or as directed by physician. It should alwaysbe taken by mouth. Measure the dose using the dosing cup (or use oneheaping tablespoon of powder), stir and dissolve in a glass (8 oz) of water,juice, soda, coffee, or tea. Taking more than the prescribed dose may causeloss of fluid due to severe diarrhea.

How will it workGlycoLax™ softens the stool and increases the frequency of bowel move-ments by retaining water in the stool. Your first bowel movement will usu-ally happen in two to four days, although results may vary for individualpatients.

How long should I take itGlycoLax™ achieves its best results when used between one and twoweeks. You may discontinue taking the drug after you have had several sat-isfactory bowel movements. Should unusual cramps, bloating, or diarrheaoccur, consult your physician. GlycoLax™ is intended for up to a two weekcourse of therapy. You should not use for a longer time unless directed byyour physician.

Next StepsAfter successfully completing the GlycoLax™ therapy (usually between oneand two weeks), please discuss with your physician lifestyle changes whichmay produce more regular bowel habits (adequate dietary and fluid intake,regular exercise).

Who Should NOT take GlycoLax™GlycoLax™ should not be used by children. It should not be used by preg-nant women unless prescribed by a physician.

Side Effects/Drug ReactionsOccasionally, GlycoLax™ may cause nausea, stomach fullness, cramping,diarrhea and/or gas. Do not take if you have symptoms such as nausea,vomiting, abdominal pain or distention, which may be due to bowelobstruction. On rare occasions, hives and skin rashes have been reportedwhich are suggestive of an allergic reaction. If you get an allergic reaction,you should discontinue the medication and call your physician.

If you are allergic to polyethylene glycol, do not use this drug.Kremers Urban, Inc.

Mequon, WI 53092, USA

GlycoLax™(Polyethylene Glycol 3350 Powder for Oral Solution)

Rx Only

DESCRIPTION A white powder for reconstitution. GlycoLax™ (Polyethylene Glycol 3350Powder for Oral Solution) is a synthetic polyglycol having an average molec-ular weight of 3350. The actual molecular weight is not less than 90.0 per-cent and not greater than 110.0 percent of the nominal value. The chemicalformula is HO(C2H4O)nH in which n represents the average number ofoxyethylene groups. Below 55°C, it is a free flowing white powder freely solu-ble in water. GlycoLax™ is an osmotic agent for the treatment of constipation.

CLINICAL PHARMACOLOGY Pharmacology: GlycoLax™ is an osmotic agent which causes water to beretained with the stool. Essentially, complete recovery of GlycoLax™ wasshown in normal subjects without constipation. Attempts at recovery ofGlycoLax™ in constipated patients resulted in incomplete and highly vari-able recovery. In vitro study showed indirectly that GlycoLax™ was not fer-mented into hydrogen or methane by the colonic microflora in humanfeces. GlycoLax™ appears to have no effect on the active absorption orsecretion of glucose or electrolytes. There is no evidence of tachyphylaxis.

CLINICAL TRIALSIn one study, patients with less than 3 bowel movements per week wererandomized to GlycoLax™, 17 grams, or placebo for 14 days. An increasein bowel movement frequency was observed for both treatment groupsduring the first week of treatment. GlycoLax™ was statistically superior toplacebo during the second week of treatment.

In another study, patients with 3 bowel movements or less per week and/orless than 300 grams of stool per week were randomized to 2 dose levels ofGlycoLax™ or placebo for 10 days each. Success was defined by anincrease in both bowel movement frequency and daily stool weight. Forboth parameters, superiority of the 17 gram dose of GlycoLax™ over place-bo was demonstrated.

INDICATIONS AND USAGE For the treatment of occasional constipation. This product should be usedfor 2 weeks or less or as directed by a physician.

CONTRAINDICATIONS GlycoLax™ is contraindicated in patients with known or suspected bowelobstruction and patients known to be allergic to polyethylene glycol.

WARNINGS Patients with symptoms suggestive of bowel obstruction (nausea, vomit-ing, abdominal pain or distention) should be evaluated to rule out this con-dition before initiating GlycoLax™ therapy.

PRECAUTIONS General: Patients presenting with complaints of constipation should have athorough medical history and physical examination to detect associatedmetabolic, endocrine and neurogenic conditions, and medications. A diag-nostic evaluation should include a structural examination of the colon.Patients should be educated about good defecatory and eating habits (suchas high fiber diets) and lifestyle changes (adequate dietary fiber and fluidintake, regular exercise) which may produce more regular bowel habits.

GlycoLax™ should be administered after being dissolved in approximately 8ounces of water, juice, soda, coffee, or tea.

Information for Patients: GlycoLax™ softens the stool and increases thefrequency of bowel movements by retaining water in the stool. It shouldalways be taken by mouth after being dissolved in 8 ounces of water, juice,soda, coffee, or tea. Should unusual cramps, bloating, or diarrhea occur,consult your physician.

Two to 4 days may be required to produce a bowel movement. This prod-uct should be used for 2 weeks or less or as directed by a physician.Prolonged, frequent or excessive use of GlycoLax™ may result in elec-trolyte imbalance and dependence on laxatives.

Schwarz Pharma PCL4555 100% 4'' x 16.8125'' (folded size 3.4375'' x 4'') BLACK PMS 2597 PMS 877

Schwarz Pharma PCL4555A Base 100% 8.0625'' x 4'' BLACK PMS 2597 PMS 877

Laboratory Tests:No clinically significant effects on laboratory tests havebeen demonstrated.

Drug Interactions:No specific drug interactions have been demonstrated.

Carcinogenesis, Mutagenesis, Impairment of Fertility:Long-term carcino-genicity studies, genetic toxicity studies and reproductive toxicity studies inanimals have not been performed with GlycoLax™.

Pregnancy:Category C. Animal reproductive studies have not been per-formed with GlycoLax™. It is also not known whether GlycoLax™ cancause fetal harm when administered to a pregnant woman, or can affectreproductive capacity. GlycoLax™ should only be administered to a preg-nant woman if clearly needed.

Pediatric Use:Safety and effectiveness in pediatric patients has not beenestablished.

Geriatric Use:There is no evidence for special considerations whenGlycoLax™ is administered to elderly patients.

In geriatric nursing home patients, a higher incidence of diarrhea occurredat the recommended 17 gram dose. If diarrhea occurs, GlycoLax™ shouldbe discontinued.

ADVERSE REACTIONS Nausea, abdominal bloating, cramping and flatulence may occur. Highdoses may produce diarrhea and excessive stool frequency, particularly inelderly nursing home patients.

Patients taking other medications containing polyethylene glycol have occa-sionally developed urticaria suggestive of an allergic reaction.

OVERDOSAGE There have been no reports of accidental overdosage. In the event of over-dosage, diarrhea would be the expected major event. If an overdose ofdrug occurred without concomitant ingestion of fluid, dehydration due todiarrhea may result. Medication should be terminated and free wateradministered. The oral LD50is >50 gm/kg in mice, rats and rabbits.

DOSAGE AND ADMINISTRATION The usual dose is 17 grams (about 1 heaping tablespoonful) of powder perday (or as directed by physician) in 8 ounces of water, juice, soda, coffee,or tea. Each bottle of GlycoLax™ is supplied with a dosing cup marked tocontain 17 grams of laxative powder when filled to the indicated line.

Two to 4 days (48 to 96 hours) may be required to produce a bowel move-ment.

HOW SUPPLIED In powdered form, for oral administration after dissolution in water, juice,soda, coffee, or tea. GlycoLax™ (Polyethylene Glycol 3350 Powder for OralSolution) is available in three package sizes: a 16 oz. container of 255grams of laxative powder (NDC 62175-442-15), a 24 oz. container of 527grams of laxative powder (NDC 62175-442-31), and a carton of 14 individ-ual packets containing a single 17 gram dose (NDC 62175-442-14).

The dosing cup supplied with each bottle is marked with a measuring lineand may be used to measure a single GlycoLax™ dose of 17 grams (about1 heaping tablespoonful).

Each individual packet contains a single GlycoLax™ dose of 17 grams(about 1 heaping tablespoonful).

Store at 20°- 25°C (68°- 77°F); excursions permitted between 15°- 30°C(59°- 86°F) [See USP Controlled Room Temperature].

Kremers Urban, LLCMequon, WI 53092, USA

PCL4555ARev. 03/04

PATIENT INFORMATION

GlycoLax™ (Polyethylene Glycol 3350 Powder for Oral Solution) is a pre-scription only laxative which has been prescribed by your physician to treatconstipation. This product should only be used by the person for whom itwas prescribed.

How to takeThe dose is 17 grams each day or as directed by physician. It should alwaysbe taken by mouth. Measure the dose using the dosing cup (or use oneheaping tablespoonful of powder), stir and dissolve in a glass (8 oz) ofwater, juice, soda, coffee, or tea. Taking more than the prescribed dose maycause loss of fluid due to severe diarrhea.

How will it workGlycoLax™ softens the stool and increases the frequency of bowel move-ments by retaining water in the stool. Your first bowel movement will usu-ally happen in two to four days, although results may vary for individualpatients.

How long should I take itGlycoLax™ achieves its best results when used between one and twoweeks. You may discontinue taking the drug after you have had several sat-isfactory bowel movements. Should unusual cramps, bloating, or diarrheaoccur, consult your physician. GlycoLax™ is intended for up to a two weekcourse of therapy. You should not use for a longer time unless directed byyour physician.

Next StepsAfter successfully completing the GlycoLax™ therapy (usually between oneand two weeks), please discuss with your physician lifestyle changes whichmay produce more regular bowel habits (adequate dietary and fluid intake,regular exercise).

Who Should NOT take GlycoLax™GlycoLax™ should not be used by children. It should not be used by preg-nant women unless prescribed by a physician.

Side Effects/Drug ReactionsOccasionally, GlycoLax™ may cause nausea, stomach fullness, cramping,diarrhea and/or gas. Do not take if you have symptoms such as nausea,vomiting, abdominal pain or distention, which may be due to bowelobstruction. On rare occasions, hives and skin rashes have been reportedwhich are suggestive of an allergic reaction. If you get an allergic reaction,you should discontinue the medication and call your physician.

If you are allergic to polyethylene glycol, do not use this drug product.Kremers Urban, LLC

Mequon, WI 53092, USA

GlycoLax™(Polyethylene Glycol 3350 Powder for Oral Solution)

Rx Only

DESCRIPTION A white powder for reconstitution. GlycoLax™ (Polyethylene Glycol 3350Powder for Oral Solution) is a synthetic polyglycol having an average molec-ular weight of 3350. The actual molecular weight is not less than 90.0 per-cent and not greater than 110.0 percent of the nominal value. The chemicalformula is HO(C2H4O)nH in which n represents the average number ofoxyethylene groups. Below 55°C, it is a free flowing white powder freely solu-ble in water. GlycoLax™ is an osmotic agent for the treatment of constipation.

CLINICAL PHARMACOLOGY Pharmacology: GlycoLax™ is an osmotic agent which causes water to beretained with the stool. Essentially, complete recovery of GlycoLax™ wasshown in normal subjects without constipation. Attempts at recovery ofGlycoLax™ in constipated patients resulted in incomplete and highly vari-able recovery. In vitro study showed indirectly that GlycoLax™ was not fer-mented into hydrogen or methane by the colonic microflora in humanfeces. GlycoLax™ appears to have no effect on the active absorption orsecretion of glucose or electrolytes. There is no evidence of tachyphylaxis.

CLINICAL TRIALSIn one study, patients with less than 3 bowel movements per week wererandomized to GlycoLax™, 17 grams, or placebo for 14 days. An increasein bowel movement frequency was observed for both treatment groupsduring the first week of treatment. GlycoLax™ was statistically superior toplacebo during the second week of treatment.

In another study, patients with 3 bowel movements or less per week and/orless than 300 grams of stool per week were randomized to 2 dose levels ofGlycoLax™ or placebo for 10 days each. Success was defined by anincrease in both bowel movement frequency and daily stool weight. Forboth parameters, superiority of the 17 gram dose of GlycoLax™ over place-bo was demonstrated.

INDICATIONS AND USAGE For the treatment of occasional constipation. This product should be usedfor 2 weeks or less or as directed by a physician.

CONTRAINDICATIONS GlycoLax™ is contraindicated in patients with known or suspected bowelobstruction and patients known to be allergic to polyethylene glycol.

WARNINGS Patients with symptoms suggestive of bowel obstruction (nausea, vomit-ing, abdominal pain or distention) should be evaluated to rule out this con-dition before initiating GlycoLax™ therapy.

PRECAUTIONS General: Patients presenting with complaints of constipation should have athorough medical history and physical examination to detect associatedmetabolic, endocrine and neurogenic conditions, and medications. A diag-nostic evaluation should include a structural examination of the colon.Patients should be educated about good defecatory and eating habits (suchas high fiber diets) and lifestyle changes (adequate dietary fiber and fluidintake, regular exercise) which may produce more regular bowel habits.

GlycoLax™ should be administered after being dissolved in approximately 8ounces of water, juice, soda, coffee, or tea.

Information for Patients: GlycoLax™ softens the stool and increases thefrequency of bowel movements by retaining water in the stool. It shouldalways be taken by mouth after being dissolved in 8 ounces of water, juice,soda, coffee, or tea. Should unusual cramps, bloating, or diarrhea occur,consult your physician.

Two to 4 days may be required to produce a bowel movement. This prod-uct should be used for 2 weeks or less or as directed by a physician.Prolonged, frequent or excessive use of GlycoLax™ may result in elec-trolyte imbalance and dependence on laxatives.

PharmaLabel PCL4555A 100% 4'' x 16.8125'' (folded size 3.4375'' x 4'') BLACK PMS 2597 PMS 877