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  5. Label Information: Polyethylene Glycol 3350

FDA Label for Polyethylene Glycol 3350

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH DOSE)
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL

Polyethylene Glycol 3350 Product Label

The following document was submitted to the FDA by the labeler of this product Padagis Israel Pharmaceuticals Ltd. 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 (In Each Dose)



Polyethylene Glycol 3350, 17 g (cap filled to line)


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. (1-800-222-1222)


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 (white section in cap)
  • •adults and children 17 years of age and older:
  • •fill to top of white 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 printed foil seal under cap is missing, open or broken

Inactive Ingredients



none


Questions Or Comments?



1-800-719-9260


Principal Display Panel



Compare to MiraLAX® active ingredient

Polyethylene Glycol 3350

Powder for Solution

Osmotic Laxative

Relieves Occasional Constipation/Irregularity

Softens Stool

Unflavored Powder

Grit Free

NET WT 8.3 OZ (238 g)

14 Once-Daily Doses


* Please review the disclaimer below.