FDA Label for Polyethylene Glycol 3350 Nf

View Indications, Usage & Precautions

Polyethylene Glycol 3350 Nf Product Label

The following document was submitted to the FDA by the labeler of this product Woodward Pharma Services Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Polyethylene Glycol 3350, 17 g


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 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:

    ○ stir and dissolve one packet 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 printed foil pouch is open or broken

Inactive Ingredient



none


Questions Or Comments?



1-888-514-4727


Principal Display Panel



NDC 69784-180-14

Original Prescription Strength

PEG3350

Polyethylene Glycol 3350

Powder for Oral Solution, Osmotic Laxative

Relieves Occasional Constipation (irregularity)

Softens Stool

14 ct Unit-Dose Packets
0.5 OZ (17 gm) each


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