Label: POLYETHYLENE GLYCOL 3350 NF- polyethylene glycol 3350 powder, for solution

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

Drug Label Information

Updated January 27, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each dose)                     

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

  • Purpose

    Osmotic Laxative

  • Uses

    • 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

  • SPL UNCLASSIFIED SECTION

    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 doctor or pharmacist before use if you are

    taking a prescription drug

  • When Using this product

    you may 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 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 (clear section in cap)
    • adults and children 17 years of age and older:

      ○ fill to top of clear 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 foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken
  • INACTIVE INGREDIENT

    None

  • Questions or comments?

    1-800-FDA-1088

    Distributed by:
    Nuvo Pharmaceutical, Inc.
    Rahway, NJ 07065

    Manufactured by:
    Sunrise Pharmaceutical, Inc.
    Rahway, NJ 07065

  • PRINCIPAL DISPLAY PANEL-119 g per Bottle

    NDC 425756-180-19

    Polyethylene Glycol

    3350

    Powder for Solution, Osmotic Laxative

    • Relieves Occasional

      Constipation/Irregularity

    • Softens Stool
    • Dissolves in Any Beverage

      Unflavored Powder Grit Free

      Polyethylene Glycol 3350 increases frequency of bowel movements and softens the stool.

      9a6f7c98-figure-01

      PRINCIPAL DISPLAY PANEL -238 g per Bottle

      NDC 425756-180-28

      Polyethylene Glycol

      3350

      Powder for Solution, Osmotic Laxative

    • Relieves Occasional

      Constipation/Irregularity

    • Softens Stool
    • Dissolves in Any Beverage

      Unflavored Powder Grit Free

      Polyethylene Glycol 3350 increases frequency of bowel movements and softens the stool.

      9a6f7c98-figure-02

      PRINCIPAL DISPLAY PANEL -510 g per Bottle

      NDC 425756-180-50

      Polyethylene Glycol

      3350

      Powder for Solution, Osmotic Laxative

    • Relieves Occasional

      Constipation/Irregularity

    • Softens Stool
    • Dissolves in Any Beverage

    Unflavored Powder Grit Free

    Polyethylene Glycol 3350 increases frequency of bowel movements and softens the stool.

    9a6f7c98-figure-03

  • INGREDIENTS AND APPEARANCE
    POLYETHYLENE GLYCOL 3350 NF 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42576-180
    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:42576-180-19119 g in 1 BOTTLE; Type 0: Not a Combination Product07/03/2017
    2NDC:42576-180-28238 g in 1 BOTTLE; Type 0: Not a Combination Product07/03/2017
    3NDC:42576-180-50510 g in 1 BOTTLE; Type 0: Not a Combination Product07/03/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20610507/03/2017
    Labeler - NUVO PHARMACEUTICAL INC. (078366708)
    Registrant - NUVO PHARMACEUTICAL INC. (078366708)
    Establishment
    NameAddressID/FEIBusiness Operations
    SUNRISE PHARMACEUTICAL INC.168522378MANUFACTURE(42576-180) , ANALYSIS(42576-180) , PACK(42576-180)
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