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
  • Category: HUMAN OTC DRUG LABEL
  • 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.

View All Sections
  • 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

    none

  • Questions or comments?

    1-800-645-2158

  • Principal Display Panel

    Rugby®

    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
  • INGREDIENTS AND APPEARANCE
    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
    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: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
    ANDAANDA09068501/05/2015
    Labeler - Rugby Laboratories (079246066)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!