Label: CLEARLAX- polyethylene glycol powder, for solution

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

Drug Label Information

Updated January 12, 2011

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

  • Active ingredient

    Polyethylene Glycol

  • Purpose

    Use(s)

    • relieves occasional constipation (irregularity)

    • generally produces a bowel movement in 1 to 3 days

  • Keep Out of Reach of Children

  • Uses

    Use(s)

    • relieves occasional constipation (irregularity)

    • generally produces a bowel movement in 1 to 3 days

  • 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

    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

    Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Directions

    • do not take more than directed unless advised by your doctor

    • adults and children 17 years of age and older:

    • stir and dissolve one packet of powder (17 g) 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

    • 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 (white section in cap)

    • adults and children 17 years of age and older:

    • fill to top of white section 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 pouch is open or broken (Pouch Carton Only)

    • tamper-evident: do not use if printed foil seal under cap is missing, open or broken (Label Only)

  • Inactive ingredients

    Inactive ingredients

    none

  • Package/Label Principal Display Panel

    Clearlax (Polyethylene Glycol) 17gm

  • INGREDIENTS AND APPEARANCE
    CLEARLAX 
    polyethylene glycol powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-566(NDC:0113-0306)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 335017 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-566-1010 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09068510/07/2009
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK