Label: EZ2GO  - polyethylene glycol 3350 powder 

  • Label RSS
  • NDC Code(s): 76470-005-05
  • Packager: Valley Medical Products,LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 09/13

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

  • INACTIVE INGREDIENT

    Inactive Ingredients   none

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  • ACTIVE INGREDIENT

    Active Ingredient

    Polyethylene Glycol 3350, 17 g

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  • PURPOSE

    Purpose

    Osmotic Laxative

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  • 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 stools

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  • 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


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  • 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 may occur. you may report the side effects

    to FDA at 1 - 800 - FDA - 1088

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  • 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.

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  • PREGNANCY OR BREAST FEEDING

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

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  • DOSAGE & ADMINISTRATION

    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 (17g) 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



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  • QUESTIONS

    Questions or comments?

    1-800-403-9832

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  • INDICATIONS & USAGE

    Use

    -relieves occasional constipation (irregularity)

    -generally produces a bowel movement in 1 to 3 days

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  • INGREDIENTS AND APPEARANCE
    EZ2GO  
    polyethylene glycol 3350 powder
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:76470-005
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) POLYETHYLENE GLYCOL 3350 17 g  in 17 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76470-005-05 238 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091077 10/20/2012
    Labeler - Valley Medical Products,LLC (969389407)
    Establishment
    Name Address ID/FEI Business Operations
    Valley Medical Products,LLC 969389407 relabel(76470-005), repack(76470-005)
    Establishment
    Name Address ID/FEI Business Operations
    Novel Laboratories, Inc. 793518643 manufacture(76470-005)
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