Label: GAVILAX- polyethylene glycol 3350 powder, for solution

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

Drug Label Information

Updated January 26, 2021

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

  • Active Ingredient

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

  • 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 the 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
    • 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) then drink
    • use once a day
    • 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 seal under cap is missing, open or broken
  • Inactive Ingredient

    none

  • Questions or comments?

    1-866-403-7592

  • GAVILAX (POLYETHYLENE GLYCOL-3350) POWDER, FOR SOLUTION

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  • INGREDIENTS AND APPEARANCE
    GAVILAX  
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0312(NDC:43386-312)
    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
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-0312-117 g in 1 BAG; Type 0: Not a Combination Product01/26/2021
    2NDC:17856-0312-28.5 g in 1 BAG; Type 0: Not a Combination Product01/26/2021
    3NDC:17856-0312-317 g in 1 CUP; Type 0: Not a Combination Product01/26/2021
    4NDC:17856-0312-44 g in 1 BAG; Type 0: Not a Combination Product01/26/2021
    5NDC:17856-0312-550 in 1 CASE01/26/2021
    58.5 g in 1 CUP; Type 0: Not a Combination Product
    6NDC:17856-0312-672 in 1 CASE01/26/2021
    64.5 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09107710/09/2009
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Registrant - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    ATLANTIC BIOLOGICALS CORP.047437707RELABEL(17856-0312) , REPACK(17856-0312)