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  5. Label Information: Polyethylene Glycol 3350

FDA Label for Polyethylene Glycol 3350

View Indications, Usage & Precautions

Table of Contents

    1. POLYETHYLENE GLYCOL 3350, POWDER FOR SOLUTION
    2. ACTIVE INGREDIENT (IN EACH DOSE)
    3. PURPOSE
    4. USE
    5. ALLERGY ALERT:
    6. OTC - DO NOT USE
    7. OTC - ASK DOCTOR
    8. OTC - ASK DOCTOR/PHARMACIST
    9. OTC - WHEN USING
    10. OTC - STOP USE
    11. OTC - PREGNANCY OR BREAST FEEDING
    12. OTC - KEEP OUT OF REACH OF CHILDREN
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS OR COMMENTS?
    17. OTHER
    18. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Polyethylene Glycol 3350 Product Label

The following document was submitted to the FDA by the labeler of this product Sun Pharmaceutical Industries, 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.

Polyethylene Glycol 3350, Powder For Solution



Drug Facts


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

Allergy Alert:



Do not use if you are allergic to polyethylene glycol


Otc - Do Not Use



Do not use if you have kidney disease, except under the advice and supervision of a doctor


Otc - Ask 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

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking a prescription drug


Otc - When Using



When using this product you may have loose, watery, more frequent stools


Otc - Stop Use



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

Otc - Pregnancy Or Breast Feeding



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. 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
  • 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:
    • use once a day
    • fill to top of white section in cap which is marked to indicate the correct dose (17 grams)
    • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    • do not combine with starch-based thickeners 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° to 25°C (68° to 77°F)
  • tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

Inactive Ingredients



none


Package Label.Principal Display Panel



POLYETHYLENE GLYCOL, 3350 - 765 g - 45 Doses - Container Label [Front]

Instalax Polyethylene Glycol 3350 (765G) Container Label - Back


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