Label: EZ2GO - polyethylene glycol 3350 powder

  • 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

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 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 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) 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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