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  5. Label Information: Polyethylene Glycol 3350

FDA Label for Polyethylene Glycol 3350

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH DOSE)
    3. PURPOSE
    4. USE
    5. ALLERGY ALERT
    6. OTC - DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. OTC - ASK DOCTOR/PHARMACIST
    9. OTC - WHEN USING
    10. STOP USE AND ASK A DOCTOR IF
    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. PRINCIPAL DISPLAY PANEL - 238 G BOTTLE LABEL
    18. PRINCIPAL DISPLAY PANEL - 510 G BOTTLE LABEL

Polyethylene Glycol 3350 Product Label

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

Other



Drug Facts

Manufactured by:
LGM Pharma Solutions, LLC
Irvine, CA 92614

Distributed by:
Breckenridge Pharmaceutical, Inc.
Berlin, CT 06037


Active Ingredient (In Each Dose)



Polyethylene Glycol 3350, 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

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.


Otc - Keep Out Of Reach Of Children



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
  • 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:
    • 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
    • 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 younger: ask a doctor

Other Information



  • store at 20° - 25°C (68° - 77°F)
  • tamper-evident: do not use if seal under cap printed with "SEALED for YOUR PROTECTION" is missing, open or broken.

Inactive Ingredients



none


Questions Or Comments?



call: 1-800-367-3395


Principal Display Panel - 238 G Bottle Label



NDC 51991-961-58

Polyethylene Glycol
3350 NF

Powder for
Solution, Osmotic Laxative

Principal Display Panel - 510 G Bottle Label



NDC 51991-962-57

Polyethylene Glycol
3350 NF

Powder For Solution,
Osmotic Laxative

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