EZ2GO PEG 3350 (POLYETHYLENE GLYCOL 3350) POWDER [VALLEY MEDICAL PRODUCTS,LLC]

EZ2GO PEG 3350 (POLYETHYLENE GLYCOL 3350) POWDER [VALLEY MEDICAL PRODUCTS,LLC]
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NDC 76470-006-06
Set ID b320796c-39d5-4cbc-9a41-4aa42952f296
Category HUMAN OTC DRUG LABEL
Packager Valley Medical Products,LLC
Generic Name
Product Class
Product Number
Application Number ANDA091077
  • INACTIVE INGREDIENT

    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 OR BREAST FEEDING

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

  • DOSAGE & 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?

    1-800-403-9832

  • INDICATIONS & USAGE

    Use

    -relieves occasional constipation (irregularity)

    -generally produces a bowel movement in 1 to 3 days

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    EZ2GO  PEG 3350
    polyethylene glycol 3350 powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76470-006
    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:76470-006-06238 g in 1 BOTTLE; Type 0: Not a Combination Product10/20/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09107710/20/2012
    Labeler - Valley Medical Products,LLC (969389407)

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