Label: POLYETHYLENE GLYCOL 3350 NF- polyethylene glycol 3350 powder, for solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 29, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Polyethylene Glycol 3350, 17 g

  • Purpose

    Osmotic Laxative

  • Use

    • relieves occasional constipation (irregularity)
    • generally produces a bowel movement in 1 to 3 days
  • Warnings

    Allergy alert:

    Do not use if you are allergic to polyethylene glycol

    Do not use if you have kidney disease, except under the advice and supervision of a doctor

  • SPL UNCLASSIFIED SECTION

    Ask a doctor before use if you have

    • nausea, vomiting or abdominal pain
    • a sudden change in bowel habits that lasts over 2 weeks
    • irritable bowel syndrome
  • Ask doctor or pharmacist before use if you are

    taking a prescription drug

  • When using this product

    you may have loose, watery, more frequent stools

  • Stop use and ask a doctor if

    • you have rectal bleeding or your nausea, bloating, 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
  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

    In case of overdose, get medical help or contact a POISON CONTROL CENTER right away.

  • Directions

    • do not take more than directed unless advised by your doctor
    • adults and children 17 years of age and older:

      ○ stir and dissolve one packet in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink

      ○ use once a day

      ○ use no more than 7 days

    • children 16 years of age or under: ask a doctor
  • Other information

    • store at 20° - 25°C (68° - 77°F)
    • tamper- evident: do not use if printed foil pouch is open or broken
  • Inactive ingredient

    none

  • Questions or comments?

    1-888-514-4727

  • PRINCIPAL DISPLAY PANEL

    NDC 69784-180-01

    Compare to MiraLAX®

    Original Prescription Strength

    PEG3350

    Polyethylene Glycol 3350

    Powder for Oral Solution, Osmotic Laxative

    Relieves Occasional Constipation (irregularity)

    Softens Stool

    NET WT 0.5 OZ (17gm)

    1 DOSE

    2ffddd92-figure-03

  • PRINCIPAL DISPLAY PANEL

    NDC 69784-180-14

    Compare to MiraLAX®

    Original Prescription Strength

    PEG3350

    Polyethylene Glycol 3350

    Powder for Oral Solution, Osmotic Laxative

    Relieves Occasional Constipation (irregularity)

    Softens Stool

    14 ct Unit-Dose Packets
    0.5 OZ (17 gm) each

    2ffddd92-figure-03

  • INGREDIENTS AND APPEARANCE
    POLYETHYLENE GLYCOL 3350 NF 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69784-180(NDC:11534-180)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 335017 g  in 17 g
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69784-180-1414 in 1 CARTON06/06/2018
    1NDC:69784-180-0117 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:69784-180-3030 in 1 CARTON06/06/2018
    2NDC:69784-180-0117 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:69784-180-10100 in 1 CARTON06/06/2018
    3NDC:69784-180-0117 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20610506/06/2018
    Labeler - Woodward Pharma Services LLC (080406260)
    Registrant - Woodward Pharma Services LLC (080406260)
    Establishment
    NameAddressID/FEIBusiness Operations
    Future Pak, Ltd.087737672repack(69784-180)
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