Label: SKY PEG3350- polyethylene glycol 3350 powder, for solution

  • NDC Code(s): 63739-198-61, 63739-198-62
  • Packager: McKesson Corporation dba SKY Packaging
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 14, 2022

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  • Active ingredient (in each dose)

    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

    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
    •
    adults and children 17 years of age and older:
    •
    use once a day
    •
    stir and dissolve one packet of powder (17 g) 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 are any clumps
    •
    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 ingredients

    none

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    SKY

    Compare to MiraLAX® active ingredient

    PEG3350

    Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative

    - Relieves Occasional Constipation (Irregularity) –

    - Softens Stool -

    Unflavored Powder ● Grit Free

    Unflavored Powder Dissolves In Any Beverage!

    30 Once-Daily Doses

    30 Packets – NET WT 0.5 OZ (17g) Each

    PEG3350 Carton Image 1
    PEG3350 Carton Image 2
  • INGREDIENTS AND APPEARANCE
    SKY PEG3350 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63739-198
    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:63739-198-6130 in 1 CARTON06/08/2020
    1NDC:63739-198-6217 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09068506/08/2020
    Labeler - McKesson Corporation dba SKY Packaging (140529962)
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