Active Ingredient (In Each Dose)
Polyethylene Glycol 3350, 17 g (cap filled to line)
Polyethylene Glycol 3350
FDA Label NDC 10135-683
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Marlex Pharmaceuticals Inc for the product Polyethylene Glycol 3350 (NDC 10135-683). 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, use, warnings, do not use, ask a doctor before use if you have, ask doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Osmotic Laxative
Use
- 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 Doctor Or Pharmacist Before Use If You Are
taking a prescription drug
When Using This Product
you may 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 cap marked to contain 17 grams of powder when filled to the indicated line (clear section in cap)
- adults and children 17 years of age and older:
○ fill to top of clear 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° - 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 Ingredient
none
Questions Or Comments?
1-800-FDA-1088
Manufactured for & Distributed by:
Marlex Pharmaceuticals, Inc.
New Castle, DE 19720
Rev. 04/19IT
Principal Display Panel
NDC 10135-0683-04
Polyethylene Glycol
3350
Powder for Solution, Osmotic Laxative
Net Wt 4.1 oz (119 g)
7 Once-Daily Doses
Principal Display Panelndc 10135-0683-04polyethylene Glycol 3350 Powder For Solution, Osmotic Laxativenet Wt 4.1 Oz (119 G)7 Once-daily Doses (Polyethylene Glycol 3350 01)
NDC 10135-0683-08
Polyethylene Glycol
3350
Powder for Solution, Osmotic Laxative
Net Wt 8.3 oz (238 g)
14 Once-Daily Doses
Principal Display Panelndc 10135-0683-08polyethylene Glycol 3350 Powder For Solution, Osmotic Laxativenet Wt 8.3 Oz (238 G)14 Once-daily Doses (Polyethylene Glycol 3350 02)
NDC 10135-0683-12
Polyethylene Glycol
3350
Powder for Solution, Osmotic Laxative
Net Wt 17.9 oz (510 g)
30 Once-Daily Doses
Principal Display Panelndc 10135-0683-12polyethylene Glycol 3350 Powder For Solution, Osmotic Laxativenet Wt 17.9 Oz (510 G)30 Once-daily Doses (Polyethylene Glycol 3350 03)
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