Polyethylene Glycol 3350 Powder, For Solution
FDA Label NDC 55154-8184

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 107, Llc for the product Polyethylene Glycol 3350 (NDC 55154-8184). 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 sachet), purpose, uses, warnings, ask a doctor before use if you have, ask a doctor of pharmacist, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Sachet)

Polyethylene Glycol 3350, NF 17g

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 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.

Keep Out Of The 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
  • adults and children 17 years of age and older:
  • stir and dissolve one sachet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature)
  • drink the solution.
  • 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° - 25°C (68° - 77°F)
  • do not use if foil is open or broken.

Inactive Ingredients

none

Questions Or Comments?

1-800-707-4621 or www.americanhealthpackaging.com

© 2019 & Distributed by
American Health Packaging
Columbus, Ohio 43217 USA

All rights reserved.

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Healthylax®

Polyethylene Glycol 3350 NF

Powder for Oral Laxative Solution

7 Sachets 0.6 Oz (17 g) Each

Bag Label (4d524ace 9de5 4f62 9263 7cd88a36b67c 00)

Bag Label (4d524ace 9de5 4f62 9263 7cd88a36b67c 00)

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