Polyethylene Glycol 3350 Increases Frequency Of Bowel Movements And Softens Stools
Drug Facts
Polyethylene Glycol 3350 Powder, For Solution
FDA Label NDC 81033-762
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kesin Pharma Corporation for the product Polyethylene Glycol 3350 (NDC 81033-762). 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 increases frequency of bowel movements and softens stools, active ingredient (in each dose), purpose, use, allergy alert:, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are taking, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Dose)
Polyethlene Glycol 3350, 17 g
Purpose
Osmotic Laxative
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
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.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children.
Overdosage
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 yearsof age and older:
- use once a day
- stir and dissolve one packet of powder (17 g) in any 4 to 8 ounce of beverage (cold, hot or room temperature) then drink
- do not combine with starch-based thickners 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°C to 25°C (68°F to 77°F)
- tamper-evident: do not use if printed foil pouch is open or broken
- this package is not child-resistant
Inactive Ingredients
none
Questions Or Comments?
Call 1-833-537-4679
Other
| TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL POUCH IS OPEN OR BROKEN |
*This product is not manufactured by Bay HealthCare LLC, owner of the registered trademark MiraLAX ®
Distributed by:
Kesin Pharma
Oldsmar, FL 34677
Package Label.Principal Display Panel
NDC 81033-762-14
Polyethylene Glycol 3350 Powder for Oral Solution
Osmotic Laxative
14 Packets
(14 once-daily-doses)
Peg3350powder_14count_carton (Peg3350powder 14ct Carton)
NDC 81033-762-30
Polyethylene Glycol 3350 Powder for Oral Solution
Osmotic Laxative
30 Packets
(30 once-daily doses)
Peg3350powder_30count_carton (Peg3350powder 30ct Carton)
NDC 81033-762-01
Polyethylene Glycol 3350 Powder for Oral Solution
Osmotic laxative
100 Packets
(100 once-daily doses)
Peg3350powder_100count_carton (Peg3350powder 100ct Carton)
* Please review the disclaimer below.
