Polyethylene Glycol 3350, Nf Powder For Solution, Laxative Powder, For Solution
FDA Label NDC 79739-7116

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lgm Pharma Solutions, Llc for the product Polyethylene Glycol 3350, Nf Powder For Solution, Laxative (NDC 79739-7116). 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 (in each dose), purpose, keep out of reach of children, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Dose)

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

Purpose

Osmotic Laxative

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

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.

Directions

  • Do not take more than directed unless advised by your doctor.
  • The bottle cap 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.
    • Ensure that the powder is fully dissolved before drinking.
    • Do not drink if there are any clumps.
    • Use once a day.
    • Use no more than 7 days.

      • Children 16 years of age or younger, ask a doctor.

Other Information

  • Store at 20°C – 25°C (68°F – 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 Or Comments?

To report SUSPECTED ADVERSE EVENTS, contact LGM Pharma Solutions, LLC at 1-877-288-1495 or www.nexgenpharma.com, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured by: Nexgen Pharma, Inc., Irvine, CA 92606, USA

Rev. 08/2020

Label Principal Display Panel

17.9 oz Container Label

9 oz Container Label

4.1 oz Container Label - Drug Facts on Extended Content Label

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