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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. USES
    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 THE 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 Mylan Institutional Inc.. 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), NF, 17 g


Purpose



Osmotic Laxative


Uses



  • •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 The 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 the contents of one pouch (17 g) into 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° to 25°C (68° to 77°F)
  • •tamper-evident: do not use if pouch is damaged or torn
  • •keep carton for future reference
  • •for institutional use only

Inactive Ingredients



none


Questions Or Comments?



1-877-INFO-RX (1-877-446-3679)

Polyethylene Glycol 3350 Powder for
Solution increases frequency of bowel
movement and softens the stool.

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.


Principal Display Panel



NDC 51079-306-30

Polyethylene Glycol (3350), NF
Powder for Solution,
Osmotic Laxative

Original Prescription Strength

* Please review the disclaimer below.