Polyethylene Glycol 3350, Nf Powder For Solution, Laxative
FDA Label NDC 0722-7116

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nexgen Pharma, Inc. for the product Polyethylene Glycol 3350, Nf Powder For Solution, Laxative (NDC 0722-7116). 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 active ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Polyethylene Glycol 3350, 17g (cap filled to the top)

Purpose

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

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 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 cup designed to contain 17 grams of powder when filled to the top rim.
  • adults and children 17 years of age and older
    • fill to the top of the bottle cap which will provide 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 younger, ask a doctor

Other Information

  • Store at 20O - 25O C (68O - 77O 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 Or Comments?

For serious adverse events call: 

1-888-710-0006

Principal Display

17.9 Oz Container Label9 oz Container Label4 oz Principal Display Panel; Drug Facts on ECL

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