Label: GAVILAX- polyethylene glycol 3350 powder, for solution

  • NDC Code(s): 43386-312-07, 43386-312-08, 43386-312-14, 43386-312-85
  • Packager: Lupin Pharmaceuticals,Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 2, 2020

If you are a healthcare professional or from the pharmaceutical industry 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
    • ensure that the powder is fully dissolved before drinking
    • do not drink if there are any lumps
    • 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, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
  • Inactive Ingredient

    none

  • Questions or comments?

    1-866-403-7592

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 43386-312-08

    Original Prescription Strength

    GaviLax

    Polyethylene Glycol 3350

    Powder for Solution, Osmotic Laxative

    14 ONCE-DAILY DOSES

    NET WT 8.3 OZ (238 g)

    238 grams

    238-part2 gram

    NDC 43386-312-14

    Original Prescription Strength

    GaviLax

    Polyethylene Glycol 3350

    Powder for Solution, Osmotic Laxative

    30 ONCE-DAILY DOSES

    NET WT 17.9 OZ (510 g)

    510 grams

  • INGREDIENTS AND APPEARANCE
    GAVILAX 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:43386-312-07119 g in 1 BOTTLE; Type 0: Not a Combination Product10/09/2009
    2NDC:43386-312-85850 g in 1 BOTTLE; Type 0: Not a Combination Product10/09/2009
    3NDC:43386-312-14510 g in 1 BOTTLE; Type 0: Not a Combination Product10/09/2009
    4NDC:43386-312-08238 g in 1 BOTTLE; Type 0: Not a Combination Product10/09/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09107710/09/2009
    Labeler - Lupin Pharmaceuticals,Inc. (089153071)
    Registrant - Novel Laboratories, Inc. (793518643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Novel Laboratories, Inc.793518643analysis(43386-312) , manufacture(43386-312) , pack(43386-312)