Polyethylene Glycol
FDA Label NDC 63940-762

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Harmon Stores, Inc for the product Polyethylene Glycol (NDC 63940-762). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each dose), purpose, use, allergy alert, ask a doctor before use if you have, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each Dose)

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

Purpose

Osmotic Laxative

Use

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

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 of 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.

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:
    • 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° to 25°C (68° to 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?

1-877-753-3935

Made in India

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Revised: 01/2017

Package Label.Principal Display Panel

NDC 63940-762-03

Polyethylene Glycol 3350

Powder for Solution

OSMOTIC LAXATIVE

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

  • Relieves Occasional Constipation (Irregularity)
  • Softens Stool
  • Dissolves in any beverage
  • Sugar Free

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

    7 Once-Daily Doses

    NET WT 4.15 OZ (119 g)

    Peg-119g (6b9592f2 983d 462f 90a2 C288bc8f6657 01)

    Peg-119g (6b9592f2 983d 462f 90a2 C288bc8f6657 01)

    NDC 63940-762-04

    Polyethylene Glycol 3350

    Powder for Solution

    OSMOTIC LAXATIVE

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

    • Relieves Occasional Constipation (Irregularity)
    • Softens Stool
    • Dissolves in any beverage
    • Sugar Free

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

      14 Once-Daily Doses

      NET WT 8.3 OZ (238 g)

      Peg-238g (6b9592f2 983d 462f 90a2 C288bc8f6657 02)

      Peg-238g (6b9592f2 983d 462f 90a2 C288bc8f6657 02)

      NDC 63940-762-05

      Polyethylene Glycol 3350

      Powder for Solution

      OSMOTIC LAXATIVE

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

      • Relieves Occasional Constipation (Irregularity)
      • Softens Stool
      • Dissolves in any beverage
      • Sugar Free

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

        30 Once-Daily Doses

        NET WT 17.9 OZ (510 g)

        Peg-510g (6b9592f2 983d 462f 90a2 C288bc8f6657 03)

        Peg-510g (6b9592f2 983d 462f 90a2 C288bc8f6657 03)

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