Label: RUGBY PEG 3350- polyethylene glycol 3350 powder, for solution

  • NDC Code(s): 0536-1052-24, 0536-1052-27, 0536-1052-84
  • Packager: Rugby Laboratories
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 10, 2022

If you are a consumer or patient please visit this version.

  • Active ingredient (in each dose)

    Polyethylene Glycol 3350, 17 g (cap filled to line)

  • 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

  • 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 a 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 (1-800-222-1222).

  • Directions

    do not take more than directed unless advised by your doctor
    the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap)
    adults and children 17 years of age and older:
    use once a day
    fill to top of white section in cap which is marked to indicate the correct dose (17 g)
    stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    do not combine with starch-based thickeners used for difficulty swallowing
    ensure that the powder is fully dissolved before drinking
    do not drink if there any clumps
    do not 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 seal under cap is missing, open or broken

    Inactive ingredients


  • Questions or comments?


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    Compare to the active ingredient in MiraLAX®

    PEG 3350

    Polyethylene Glycol 3350

    Powder for Solution

    Osmotic Laxative

    Relieves Occasional Constipation (Irregularity)

    Softens Stool

    Unflavored Grit Free Powder

    NET WT 17.9 OZ (510 g)

    30 Once-Daily Doses

    polyethylene glycol 3350 image
    RUGBY PEG 3350 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1052
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Product Characteristics
    FlavorImprint Code
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1052-24238 g in 1 BOTTLE; Type 0: Not a Combination Product01/05/2015
    2NDC:0536-1052-27510 g in 1 BOTTLE; Type 0: Not a Combination Product01/05/2015
    3NDC:0536-1052-84850 g in 1 BOTTLE; Type 0: Not a Combination Product01/05/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Labeler - Rugby Laboratories (079246066)