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GAVILAX (Preferred Pharmaceuticals, Inc)

Available Formats

Dosage Form Package Information Links
POWDER, FOR SOLUTION 238 g in 1 BOTTLE (68788-9849-2) Label Information

Complete GAVILAX Information

  • 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°â€“ 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


  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Gavilax

    NDC 68788-9849-2

    Original Prescription Strength

    GaviLax

    Polyethylene Glycol 3350

    Powder for Solution, Osmotic Laxative

    Relabeled By: Preferred Pharmaceuticals Inc.


  • INGREDIENTS AND APPEARANCE
    GAVILAX 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-9849(NDC:43386-312)
    Route of Administration ORAL
    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
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68788-9849-2 238 g in 1 BOTTLE; Type 0: Not a Combination Product 04/06/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091077 04/06/2012
    Labeler - Preferred Pharmaceuticals, Inc. (791119022)
    Registrant - Preferred Pharmaceuticals, Inc. (791119022)
    Establishment
    Name Address ID/FEI Business Operations
    Preferred Pharmaceuticals, Inc. 791119022 RELABEL(68788-9849)