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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. ALLERGY ALERT:
    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. OTHER
    17. PRINCIPAL DISPLAY PANEL

Polyethylene Glycol 3350 Product Label

The following document was submitted to the FDA by the labeler of this product Ani Pharmaceuticals, 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 USP, 17g


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 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 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 printed foil pouch is open or broken

Inactive Ingredients



None


Questions Or Comments?



1-800-308-6755


Other



Distributed by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623

10198 Rev 11/19


Principal Display Panel



NDC 62559-157-30
Polyethylene Glycol 3350
Powder for Solution,
Osmotic Laxative

  • •Relieves Occasional Constipation/Irregularity
  • •Softens Stool

    • Dissolves in any Beverage
    Sugar free

    30 Once-Daily Doses
    30 Packets NET WT 0.5 oz (17 g) Each

    30 Single Doses

    Compare to MiraLAX® Active Ingredient

    Carton-30pkt - image 01

    Carton-30pkt - image 01


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