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  5. Label Information: Polyethylene Glycol 3350, Nf Powder For Solution, Laxative

FDA Label for Polyethylene Glycol 3350, Nf Powder For Solution, Laxative

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH DOSE)
    2. PURPOSE
    3. KEEP OUT OF REACH OF CHILDREN
    4. USES
    5. WARNINGS
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. QUESTIONS OR COMMENTS?
    10. LABEL PRINCIPAL DISPLAY PANEL

Polyethylene Glycol 3350, Nf Powder For Solution, Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Lgm Pharma Solutions, 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.

Active Ingredient (In Each Dose)



Polyethylene Glycol 3350, 17 grams (cap filled to the top)


Purpose



Osmotic Laxative


Keep Out Of Reach Of Children



In case of overdose, get medical help or contact a Poison Control Center right away.


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.


Directions



  • •Do not take more than directed unless advised by your doctor.
  • •The bottle cap is a measuring cup designed to contain 17 grams of powder when filled to the top rim.
  • •Adults and children 17 years of age and older:
    • •Fill to the top of the bottle cap which will provide the correct dose (17 g).
    • •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°C – 25°C (68°F – 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?



To report SUSPECTED ADVERSE EVENTS, contact LGM Pharma Solutions, LLC at 1-877-288-1495 or www.nexgenpharma.com, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured by: Nexgen Pharma, Inc., Irvine, CA 92606, USA

Rev. 08/2020


Label Principal Display Panel



17.9 oz Container Label

9 oz Container Label

4.1 oz Container Label - Drug Facts on Extended Content Label


* Please review the disclaimer below.