Active Ingredient (In Each Dose)
Polyethylene Glycol 3350, 17 g
Polyethylene Glycol 3350 Powder, For Solution
FDA Label NDC 0904-6931
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 Polyethylene Glycol 3350 (NDC 0904-6931). 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 need to use a laxative for longer than 1 week
- you get diarrhea
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:
- stir and dissolve one packet of powder (17 g) 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 under: ask a doctor
Other Information
- store at 20° to 25°C (68° to 77°F)
- tamper-evident: do not use if foil is open or broken
Inactive Ingredients
none
Questions Or Comments?
(800) 616-2471
Principal Display Panel
NDC 0904-6931-26
Compare to MiraLAX® active ingredient*
MAJOR®
PEG3350
Polyethylene Glycol 3350
Powder for Oral Solution
Osmotic Laxative
• Relieves Occasional Constipation (Irregularity)
• Softens Stool
Dissolves in Any Beverage
Sugar Free
14 Once-Daily Doses
NET WT 0.5 OZ (17 g) Each
*This product is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademark MiraLAX®.
Distributed by MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
Product of India
Rev. 12/20 M-17
Re-order No. 701066
50844 REV0719B72648
Major 44-726 (Major 44 726 1)
* Please review the disclaimer below.
