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Polyethylene Glycol 3350 Powder for Solution, Laxative

Polyethylene Glycol 3350 Powder for Solution, Laxative

Distributed by Kremers Urban, LLC, Princeton, NJ 08540, USA 08540, NJ Princeton, LLC, Urban, Kremers by Distributed

Dissolves in any beverage any in Dissolves

movements and softens the stool. stool. the softens and movements Polyethylene Glycol 3350 increases frequency of bowel bowel of frequency increases 3350 Glycol Polyethylene 812-523-5471 Seymour, IN47274 1101 CAve.West Labeling Department Questions orcomments? 1-800-477-7877 Inactive ingredients Other information Directions Control Centerrightaway. Keep outofreachchildren.Incaseoverdose,getmedicalhelporcontactaPoison If pregnantorbreastfeeding,askahealthprofessionalbeforeuse. Drug Facts(continued) tamper-evident: donotuseifprintedfoilsealundercapismissing,openorbroken store at20°-25°C(68°77°F) children 16yearsofageorunder:askadoctor indicated line the dosingcupsuppliedismarkedtocontain17gramsofpowderwhenfilled do nottakemorethandirectedunlessadvisedbyyourdoctor adults andchildren17yearsofageolder:

use oncedaily temperature) thendrink stir anddissolveinany4to8ouncesofbeverage(cold,hotorroom fill toindicatedlineforthecorrectdose(17g) use no more than 7 days days 7 than more no use WRITTEN CONSENTOFSCHWARZ PHARMA LABELINGDEPT. THERE ARE TOBENOMODIFICATION TO COPY ORDESIGN WITHOUT SPECIAL INSTRUCTION(S): PRINTERTOMATCHARTWORK PROVIDED.

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DESIGN Date: 18Aug09 Operator: LBorden Software: adobeillustratorcs2 Die Line:81/2”x21/5” Revision: Rev.04/09 File Name: NETWT NETWT 4.1 OZ (119 g) NDC Powder for Solution, Polyethylene Glycol 3350

119g BottleLabel 62175-195-07 Use dosing CAP Stool Softens * Relieves Occasional *

is not a dosing

CUP provided to measure dose. CUP. 7

ONCE-DAILY DOSES Strength Prescription Original

COLORS PMS 2597 SPOT COLORS Drug Facts Warnings Use Polyethylene Glycol 3350, 17 g (dosing cup filled to line).... Laxative Polyethylene Glycol3350,17g(dosingcupfilledtoline).... Active ingredient(ineachdose) Stop useandaskadoctorif When usingthisproductyoumayhaveloose,watery,morefrequentstools Ask adoctorbeforeuseifyouhave and supervisionofadoctor Do notuseifyouhavekidneydisease,exceptundertheadvice Allergy alert:Donotuseifyouareallergictopolyethyleneglycol Ask a doctor or pharmacist before use if you are you getdiarrhea pain getsworse.Thesemaybesignsofaseriouscondition. you haverectalbleedingoryournausea,bloating,crampingabdominal you needtousealaxativeforlongerthan1week irritable bowelsyndrome a suddenchangeinbowelhabitsthatlastsover2weeks nausea, vomitingorabdominalpain relievesoccasionalconstipation(irregularity) generally producesabowelmovementin1to3days

Black PMS 877

BARCODE(S) takingaprescriptiondrug Purpose UPC CODE

6217519507

Lot.: Exp.: 4010359 Rev. 04/09 Dissolves in Any Beverage Polyethylene Glycol 3350 Powder for Solution increases frequency of bowel movements and softens the stool. Drug Facts (continued) NDC 62175-195-15 Original Drug Facts If pregnant or breast feeding, ask a health professional Prescription Active ingredient (in each dose) Purpose before use. Polyethylene Glycol 3350, 17 g (dosing cup filled to line)....Laxative Keep out of reach of children. In case of overdose, get medical Strength help or contact a Control Center right away. Use relieves occasional constipation (irregularity) Directions generally produces a bowel movement in 1 to 3 days do not take more than directed unless advised by your doctor the dosing cup supplied is marked to contain 17 grams of powder when filled to the indicated line Warnings adults and children 17 years of age and older: Polyethylene Glycol 3350 Allergy alert: Do not use if you are allergic to polyethylene glycol fill to indicated line for correct dose (17 g) Do not use if you have kidney disease, except under the advice stir and dissolve in any 4 to 8 ounces of beverage (cold, hot and supervision of a doctor or room temperature) then drink Powder for Solution, Laxative Ask a doctor before use if you have use once daily nausea, vomiting or abdominal pain use no more than 7 days a sudden change in bowel habits that lasts over 2 weeks children 16 years of age or under: ask a doctor * Relieves Occasional Constipation Ask a doctor or pharmacist before use if you are taking a Other information prescription drug store at 20° - 25°C (68° - 77°F) * Softens Stool tamper-evident: do not use if printed foil seal under cap is missing, When using this product you may have loose, watery, more open or broken frequent stools CAP is not a dosing CUP. Stop use and ask a doctor if Inactive ingredients none Use dosing CUP provided to measure dose. you have rectal bleeding or your nausea, bloating, cramping or Exp.: Lot.: abdominal pain gets worse. These may be signs of a serious condition.

Questions or comments? ONCE-DAILY DOSES you get diarrhea 1-800-477-7877 NETWT 8.9 OZ (255 g) 15 you need to use a laxative for longer than 1 week

Distributed by Kremers Urban, LLC, Princeton, NJ 08540 USA 4010420 Rev. 04/09

COLORS Description: 255 g Bottle Label UPC CODE Revision: Rev. 04/09 Die Line: 8.8125” x 3” Labeling Department Software: adobe illustrator cs2 PMS 2597 PMS 877 Black

1101 C Ave. West DESIGN COLORS Operator: LBorden 6217519515

Seymour, IN 47274 BARCODE(S) 812-523-5471 Date: 18Aug09 Varnish

SPECIAL INSTRUCTION(S): PRINTER TO MATCH ARTWORK PROVIDED. THERE ARE TO BE NO MODIFICATION TO COPY OR DESIGN WITHOUT WRITTEN CONSENT OF SCHWARZ PHARMA LABELING DEPT. Polyethylene Glycol 3350 Powder for Solution Dissolves in Any Beverage NDC 62175-195-31 Original increases frequency of bowel movements Prescription and softens the stool. Drug Facts (continued) Strength Drug Facts If pregnant or breast feeding, ask a health professional Active ingredient (in each dose) Purpose before use. Polyethylene Glycol 3350, 17 g (dosing cup filled to line)....Laxative Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Use relieves occasional constipation (irregularity) Directions generally produces a bowel movement in 1 to 3 days do not take more than directed unless advised by your doctor the dosing cup supplied is marked to contain 17 grams of powder Polyethylene Glycol 3350 when filled to the indicated line Warnings adults and children 17 years of age and older: Allergy alert: Do not use if you are allergic to polyethylene glycol fill to indicated line for the correct dose (17 g) Powder for Solution, Laxative Do not use if you have kidney disease, except under the advice stir and dissolve in any 4 to 8 ounces of beverage (cold, hot and supervision of a doctor or room temperature) then drink Ask a doctor before use if you have use once daily nausea, vomiting or abdominal pain use no more than 7 days a sudden change in bowel habits that lasts over 2 weeks children 16 years of age or under: ask a doctor * Relieves Occasional Constipation irritable bowel syndrome Ask a doctor or pharmacist before use if you are taking a Other information prescription drug store at 20° - 25°C (68° - 77°F) tamper-evident: do not use if printed foil seal under cap is missing, * Softens Stool When using this product you may have loose, watery, more open or broken frequent stools Stop use and ask a doctor if Inactive ingredients none CAP is not a dosing CUP. you have rectal bleeding or your nausea, bloating, cramping or Exp.: Lot.: abdominal pain gets worse. These may be signs of a serious Use dosing CUP provided to measure dose. condition. Questions or comments? you get diarrhea 1-800-477-7877 NETWT 18.5 OZ (527 g) 31 ONCE-DAILY DOSES you need to use a laxative for longer than 1 week Distributed by Kremers Urban, LLC, Princeton, NJ 08540 USA 4010421 THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN Rev. 04/09

COLORS Description: 527 g Bottle Label UPC CODE Revision: Rev. 04/09 Die Line: 8.8125” x 4” Labeling Department Software: adobe illustrator cs2 PMS 2597 PMS 877 Black

1101 C Ave. West DESIGN Operator: LBorden COLORS 6217519531

Seymour, IN 47274 BARCODE(S) 812-523-5471 Date: 18Aug09 Varnish

SPECIAL INSTRUCTION(S): PRINTER TO MATCH ARTWORK PROVIDED. THERE ARE TO BE NO MODIFICATION TO COPY OR DESIGN WITHOUT WRITTEN CONSENT OF SCHWARZ PHARMA LABELING DEPT. COLORS UPC CODE Description: Printed Foil Revision: Rev. 03/08 Die Line: 8.8125” x 3” Labeling Department PMS 2597 Black Software: adobe illustrator cs1 6217544214

1101 C Ave. West DESIGN Operator: CFeller COLORS 2D Matrix

Seymour, IN 47274 BARCODE(S) 812-523-5471 Date: 07Jan09 L5310

SPECIAL INSTRUCTION(S): PRINTER TO MATCH ARTWORK PROVIDED. THERE ARE TO BE NO MODIFICATION TO COPY OR DESIGN WITHOUT

WRITTEN CONSENT OF SCHWARZ PHARMA LABELING DEPT.

NDC 62175-195-01 Original FOLD AT LINE Prescription TEAR AT ARROW Strength

Polyethylene Glycol 3350 Powder for Solution, Laxative

* Relieves Occasional Constipation * Softens Stool

NET WT 0.5 OZ (17g) 1 Dose

Drug Facts Drug Facts (continued) Active ingredient (in each dose) Purpose If pregnant or breast feeding, ask a health professional before use. Polyethylene Glycol 3350, 17 g...... Laxative Keep out of reach of children. In case of overdose, get Use medical help or contact a Poison Control Center right away. relieves occasional constipation (irregularity) Directions generally produces a bowel movement in 1 to 3 days do not take more than directed unless advised by your doctor Warnings adults and children 17 years of age and older: Allergy alert: Do not use if you are allergic to polyethylene stir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) glycol then drink Do not use if you have kidney disease, except under the use once daily advice and supervision of a doctor use no more than 7 days Ask a doctor before use if you have children 16 years of age or under: ask a doctor nausea, vomiting or abdominal pain a sudden change in bowel habits that lasts over 2 weeks Other information irritable bowel syndrome store at 20° - 25°C (68° - 77°F) Ask a doctor or pharmacist before use if you are taking tamper-evident: do not use if foil is open or broken a presciption drug When using this product you may have loose, watery, Inactive ingredients none more frequent stools Stop use and ask a doctor if Questions or comments? you have rectal bleeding or your nausea, bloating, 1-800-477-7877 cramping or abdominal pain gets worse. These may be signs of a serious condition. you get diarrhea you need to use a laxative for longer than 1 week

Distributed by Kremers Urban, LLC FPO Princeton, NJ 08540 USA L5480 Rev. 04/09 Schwarz Pharma Miralax .5oz 10ct Unit carton 4.59375 x 2.59375 x 4.25000 SBS018 TTAB CUT 04/06/2009 SAMPLE # S090450 CREASE OUTSIDE VIEW SHOWN SCALE = 1 PARTIAL CUT HATCHED AREAS WILL BE COVERED WHEN PRINT REGISTER CARTON IS ASSEMBLED. PLEASE EXTEND BLEED INK COVERAGES OVER HATCHED AREAS SAFETY

UNDER NO CIRCUMSTANCE IS THIS DIE LINE TO BE ALTERED. IF NECESSARY - PLEASE ADVISE.

Original Prescription Strength Polyethylene Glycol 3350 Powder for Solution, Laxative

Original Original

Drug Facts Drug Facts (continued) Prescription NDC 62175-195-10 Prescription Active ingredient (in each dose) Purpose If pregnant or breast feeding, ask a health professional Original Polyethylene Glycol 3350, 17 g...... Laxative before use. Strength Strength Keep out of reach of children. In case of overdose, get medical Prescription Use help or contact a Poison Control Center right away. relieves occasional constipation (irregularity) Strength generally produces a bowel movement in 1 to 3 days Directions do not take more than directed unless advised by your doctor Warnings adults and children 17 years of age and older: Polyethylene Glycol 3350 Polyethylene Glycol 3350 stir and dissolve one packet of powder (17 g) in any 4 to Allergy alert: Do not use if you are allergic to polyethylene glycol 8 ounces of beverage (cold, hot or room temperature) then drink Do not use if you have kidney disease, except under the advice use once daily Powder for Solution, Laxative Powder for Solution, Laxative and supervision of a doctor use no more than 7 days Ask a doctor before use if you have children 16 years of age or under: ask a doctor nausea, vomiting or abdominal pain a sudden change in bowel habits that lasts over 2 weeks Other information * Relieves Occasional Constipation Polyethylene Glycol 3350 * Relieves Occasional Constipation irritable bowel syndrome store at 20° - 25°C (68° - 77°F) Ask a doctor or pharmacist before use if you are taking a tamper-evident: do not use if foil is open or broken * Softens Stool * Softens Stool presciption drug * Dissolves in Any Beverage Powder for Solution, Laxative * Dissolves in Any Beverage When using this product you may have loose, watery, more Inactive ingredients none frequent stools Stop use and ask a doctor if Questions or comments? you have rectal bleeding or your nausea, bloating, cramping or 1-800-477-7877 abdominal pain gets worse. These may be signs of a serious * Relieves Occasional Constipation condition. you get diarrhea you need to use a laxative for longer than 1 week * Softens Stool Unvarnished Area CONTAINS 10 ONCE-DAILY DOSES Distributed by Kremers Urban, LLC, Princeton, NJ 08540 USA * Dissolves in Any Beverage EACH PACKET CONTAINS ONE DOSE NET WT 0.5 OZ (17G) Control No. Exp. Date FPO 10 PACKETS, EACH 10 Barcode Area PACKET NET WT 0.5 OZ (17g) ONCE-DAILY DOSES CR5481 FPO Rev. 04/09