Label: PEG 3350- polyethylene glycol 3350 powder

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

Drug Label Information

Updated February 15, 2018

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

View All Sections
  • Inactive Ingredients

    Inactive Ingredients   none

  • Active Ingredient

    Active Ingredient (in each dose)

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

  • Purpose

    Purpose

    Osmotic Laxative

  • Warnings

    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

    When using this product, you may have loose, watery, more frequent bowel movements

  • Ask 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

  • Stop Use

    Stop use and ask a doctor if

    - you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse.These may be sogns of a serious condition.

    - you get diarrhea

    - you need to use a laxative for longer than 1 week

    - side effects occur

  • Keep Out of Reach of Children

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

  • Pregnancy Warning

    If pregnant or breast-feeding, ask a health professional before use.

  • Dosage and Administration

    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

    -adults and children 17 years of age and older:

        -fill to top of line 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) and then drink

        -use once a day

        -use no more than 7 days

    -Children 16 years of age or under:  ask a doctor

  • Questions?

    Questions or comments?

    1-800-645-2158

  • Indications and Usage

    Use

    -relieves occasional constipation (irregularity)

    -generally produces a bowel movement in 1 to 3 days

  • HOW SUPPLIED

    Product: 50090-2526

    NDC: 50090-2526-0 238 g in a BOTTLE

  • POLYETHYLENE GLYCOL 3350

    Label Image
  • INGREDIENTS AND APPEARANCE
    PEG 3350 
    polyethylene glycol 3350 powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-2526(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
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-2526-0238 g in 1 BOTTLE; Type 0: Not a Combination Product10/18/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09107701/05/2015
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-2526)
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!