Label: GAVILAX powder, for solution

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

Drug Label Information

Updated January 20, 2020

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

  • purpose

    • Osmotic Laxative

      Use

      • relieves occasional constipation (irregularity)
      • generally produces a bowel movement in 1 to 3 days
  • WARNINGS SECTION

    • 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

      Close
  • OTC - ASK DOCTOR SECTION

      • 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

  • OTC - STOP USE SECTION

      • 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.

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    In case of overdose, get medical help or contact a POISON CONTROL CENTER right away. (1-800-222-1222)

  • DOSAGE & ADMINISTRATION SECTION

      • 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
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    GAVILAX 
    gavilax powder, for solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-542(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
    Product Characteristics
    Colorwhite (white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-542-51510 g in 1 BOTTLE; Type 0: Not a Combination Product01/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09107701/01/2015
    Labeler - DirectRX (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    DirectRX079254320repack(61919-542)