Label: POLYETHYLENE GLYCOL-3350 powder, for solution

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

Drug Label Information

Updated October 6, 2009

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • OTC - ACTIVE INGREDIENT

    Active Ingredient (in each dose)..........................................Purpose

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

  • OTC - DO NOT USE

    Do not use if you have kidney disease, except under the advice and supervision of a doctor

  • OTC - ASK 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

  • OTC - ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking a prescription drug

  • OTC - WHEN USING

    When using this product you may have loose, watery, more frequent stools

  • OTC - STOP USE

    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

    • side effects occur. You may report side effects to FDA at 1-800-FDA-1088

    Drug Facts (continued)

  • OTC - PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • OTC - KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a POISON CONTROL CENTER right away.

    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

    Inactive Ingredients                             none

  • OTC - QUESTIONS

    Questions or comments?

    1-800-FDA-1088 (1-800-332-1088) or www.fda.gov

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    POLYETHYLENE GLYCOL-3350 
    polyethylene glycol-3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40032-312
    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
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40032-312-07119 g in 1 BOTTLE
    2NDC:40032-312-08238 g in 1 BOTTLE
    3NDC:40032-312-14510 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09107710/06/2009
    Labeler - Novel Laboratories, Inc. (793518643)
    ContactAddressTelephone NumberEmail Address
    Anu Radha Subramanian
    Address:400 Campus Drive
    City, State, Zip:Somerset, NJ, 08873
    Country:USA
    ++1908-603-6000;ext=6002ars@novellabs.net
    Registrant - Novel Laboratories, Inc. (793518643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Novel Laboratories, Inc.793518643MANUFACTURE, ANALYSIS, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Dow Chemical Company801038019api manufacture