Label: POLYETHYLENE GLYCOL 3350 powder, for solution

  • NDC Code(s): 57896-490-01, 57896-490-03, 57896-490-07, 57896-490-14, view more
    57896-490-30, 57896-490-45
  • Packager: Gericare Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 28, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each dose)

    Polyethylene Glycol 3350, 17 grams (cap filled to the indicated 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 reach of childreen

    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 (white section in cap)
    • adults and children 17 years of age and older:
      • use once a day
      • 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
      • do not combine with the starch-based thickeners used for difficulty swallowing
      • ensure that the powder is fully dissolved before drinking
      • do not drink if there are any clumps
      • do not use 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 ingredients

    none

  • QUESTIONS

    Questions or comments?

    1-800-540-3765

    Manufactured for:

    Geri-Care Pharmaceuticals

    1295 Townbin Ave. Lakewood, NJ 08701

    Product of India

    Issued: 07/2022

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Original

    Prescription

    Strength

    Polyethylene Glycol 3350

    Powder for Solution

    Osmotic Laxative

    • Relieves Occasional Constipation      (Irregularity)
    • Softens Stool

    TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN

    • Dissolves in any beverage
    • Sugar Free

    NDC 57896-490-01

    1 DOSE

    NET WT 0.5 OZ (17 g)

    17g sachet

    NDC 57896-490-03

    30 PACKETS

    NET WT 0.5 OZ (17 g) Each

    30s carton

    NDC 57896-490-07

    7 ONCE-DAILY DOSES

    NET WT 4.15 OZ (119 g)

    119g bottle

    NDC 57896-490-14

    14 ONCE-DAILY DOSES

    NET WT 8.3 OZ (238 g)

    238g bottle

    NDC 57896-490-30

    30 ONCE-DAILY DOSES

    NET WT 17.9 OZ (510 g)

    510g

    NDC 57896-490-45

    45 ONCE-DAILY DOSES

    NET WT 26.9 OZ (765 g)

    765g bottle
  • INGREDIENTS AND APPEARANCE
    POLYETHYLENE GLYCOL 3350 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-490
    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 (Colorless upon dissolution) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-490-07119 g in 1 CAN; Type 0: Not a Combination Product10/27/2022
    2NDC:57896-490-14238 g in 1 CAN; Type 0: Not a Combination Product10/27/2022
    3NDC:57896-490-30510 g in 1 CAN; Type 0: Not a Combination Product10/27/2022
    4NDC:57896-490-45765 g in 1 CAN; Type 0: Not a Combination Product10/27/2022
    5NDC:57896-490-0330 in 1 CARTON10/27/2022
    5NDC:57896-490-0117 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20392810/27/2022
    Labeler - Gericare Pharmaceuticals (611196254)
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