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  5. Label Information: Polyethylene Glycol 3350

FDA Label for Polyethylene Glycol 3350

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - WHEN USING
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 119 G BOTTLE LABEL

Polyethylene Glycol 3350 Product Label

The following document was submitted to the FDA by the labeler of this product Aurohealth 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.

Drug Facts



Active ingredient (in each dose)

Polyethylene Glycol 3350, USP 17 grams (cup filled to the indicated 17 grams 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


Otc - Do Not Use



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

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


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.


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Directions



  • do not take more than directed unless advised by your doctor
  • this product is supplied with a dosing cup marked to contain 17 grams of powder when filled to the indicated line
  • adults and children 17 years of age and older:
    • use once a day
    • fill to the indicated 17 grams line on cup 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 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 foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

Inactive Ingredients



none

Questions or comments?

call 1-855-274-4122

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/19/1993


Package Label-Principal Display Panel - 119 G Bottle Label



AUROHEALTH

NDC 58602-805-01

Compare to active ingredient
of MiraLax®*

Polyethylene Glycol 3350
Powder for Oral Solution

Osmotic Laxative

* Please review the disclaimer below.