Polyethylene Glycol 3350 Powder, For Solution
FDA Label NDC 72657-196

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Glenmark Therapeutics Inc., Usa for the product Polyethylene Glycol 3350 (NDC 72657-196). 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 polyethylene glycol 3350, powder for solution, active ingredient (in each dose) (can only), purpose, active ingredient (in each dose) (packet only), use, allergy alert:, otc - do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Polyethylene Glycol 3350, Powder For Solution

Drug Facts

Active Ingredient (In Each Dose) (Can Only)

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

Purpose

Osmotic Laxative

Osmotic Laxative

Active Ingredient (In Each Dose) (Packet Only)

Polyethylene Glycol 3350, 17 g

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

Otc - Do Not Use

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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking a prescription drug

Otc - When Using

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions (Can Only)

  • 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:
    • ouse once a day
    • ofill to top of white section in cap which is marked to indicate the correct dose (17 g)
    • ostir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    • odo not combine with starch-based thickeners used for difficulty swallowing
    • oensure that the powder is fully dissolved before drinking
    • odo not drink if there are any clumps
    • odo not use more than 7 days
    • children 16 years of age or under: ask a doctor

Directions (Packet Only)

  • do not take more than directed unless advised by your doctor
  • adults and children 17 years of age and older:
    • ouse once a day
    • ostir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    • odo not combine with starch-based thickeners used for difficulty swallowing
    • oensure that the powder is fully dissolved before drinking
    • odo not drink if there are any clumps
    • odo 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 Or Comments?

Call weekdays 9 AM to 5 PM at 1 (888) 721-7115

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

Distributed by

Glenmark Therapeutics Inc., USA

Mahwah, NJ 07430

Package Label.Principal Display Panel

NDC 72657-196-16Polyethylene 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 brokenUnflavoredf
  • Sugar Free
  • Dissolves in Any Beverage

    • 45 ONCE-DAILY DOSES

    NET WT 26.9 OZ (765 g) EACH

    45s Label front

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    45s Label back
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