Active Ingredient (In Each Dose)
Polyethylene Glycol 3350, 17 g
Peg3350 Powder, For Solution
FDA Label NDC 0904-7534
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Peg3350 (NDC 0904-7534). 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 a 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 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
- adults and children 17 years of age and older:
- use once a day
- stir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
- do not combine with starch-based thickeners used for difficulty swallowing
- ensure that the powder is fully dissolved before drinking
- do not drink if there are any clumps
- do 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 is open or broken
Inactive Ingredients
none
Questions Or Comments?
Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
Principal Display Panel
MAJOR®
NDC 0904-7534-26
compare to the active ingredient
in MiraLAX®*
PEG3350
polyethylene glycol 3350
powder for solution
osmotic laxative
• relieves occasional constipation/
irregularity
• softens stool
• dissolves in any beverage
• sugar free
• grit free
15 once-daily doses
(15 packets)
NET WT 0.5 OZ (17 g) each
unflavored
Major 44-772 (Major 44 772 1)
* Please review the disclaimer below.
