1. Home
  2. Labeler Index
  3. Strides Pharma Inc
  4. 59556-762
  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) (CAN ONLY)
    3. PURPOSE
    4. ACTIVE INGREDIENT (IN EACH DOSE) (PACKET ONLY)
    5. USE
    6. ALLERGY ALERT
    7. OTC - DO NOT USE
    8. ASK A DOCTOR BEFORE USE IF YOU HAVE
    9. OTC - ASK DOCTOR/PHARMACIST
    10. OTC - WHEN USING
    11. STOP USE AND ASK A DOCTOR IF
    12. OTC - PREGNANCY OR BREAST FEEDING
    13. OTC - KEEP OUT OF REACH OF CHILDREN
    14. DIRECTIONS (CAN ONLY)
    15. DIRECTION (PACKET ONLY)
    16. OTHER INFORMATION
    17. INACTIVE INGREDIENT
    18. QUESTIONS OR COMMENTS?
    19. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Polyethylene Glycol 3350 Product Label

The following document was submitted to the FDA by the labeler of this product Strides Pharma 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) (Can Only)



Polyethylene Glycol 3350, 17 g (cap filled to line)


Purpose



Osmotic Laxative

Osmotic Laxative


Active Ingredient (In Each Dose) (Packet Only)



Polyethylene Glycol 3350, 17 g


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


Directions (Can Only)



  • 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:
    • fill to top of white section in cap which is marked to indicate the correct dose (17 g)
    • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    • use once a day
    • use no more than 7 days
    • children 16 years of age or under: ask a doctor

Direction (Packet Only)



  • 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
    • 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 foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

Inactive Ingredient



none


Questions Or Comments?



1-877-244-9825

Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool.

Manufactured by

Strides Shasun Limited

Bangalore-560076, India

Distributed by

Strides Pharma Inc.

East Brunswick, NJ 08816


Package Label.Principal Display Panel



10

Packets

NDC 64380-762-01

Polyethylene Glycol 3350

Powder for Solution

Osmotic Laxative

  • Relieves Occasional Constipation (Irregularity)
  • Softens Stool

    • TAMPER-EVIDENT: DO NOT USE IF FOIL IS OPEN OR BROKEN

    • Dissolves in any beverage
    • Sugar Free

      • 10 ONCE-DAILY DOSES

      10 PACKETS

      NET WT 0.5 OZ (17g) EACH

      10s carton

      24

      Packets

      NDC 64380-762-02

      Polyethylene Glycol 3350

      Powder for Solution

      Osmotic Laxative

      • Relieves Occasional Constipation (Irregularity)
      • Softens Stool

        • TAMPER-EVIDENT: DO NOT USE IF FOIL IS OPEN OR BROKEN

        • Dissolves in any beverage
        • Sugar Free

          • 24 ONCE-DAILY DOSES

          24 PACKETS

          NET WT 0.5 OZ (17g) EACH

          24s carton

          NDC 64380-762-00

          Original

          Prescription

          Strength

          Polyethylene Glycol 3350

          Powder for Solution

          Osmotic Laxative

          • Relieves Occasional Constipation (Irregularity)
          • Softens Stool

            • TAMPER-EVIDENT: DO NOT USE IF FOIL IS OPEN OR BROKEN

            • Dissolves in any beverage
            • Sugar Free

              • 1 DOSE

              NET WT 0.5 OZ (17 g)

              packet

              NDC 64380-762-03

              Original

              Prescription

              Strength

              Polyethylene Glycol 3350

              Powder for Solution

              Osmotic Laxative

              • Relieves Occasional Constipation (Irregularity)
              • Softens Stool

                • TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN

                • Dissolves in any beverage
                • Sugar Free

                  • 7

                  ONCE-DAILY

                  DOSES

                  NET WT 4.15 OZ (119 g)

                  119 g CAN

                  NDC 64380-762-04

                  Original

                  Prescription

                  Strength

                  Polyethylene Glycol 3350

                  Powder for Solution

                  Osmotic Laxative

                  • Relieves Occasional Constipation (Irregularity)
                  • Softens Stool

                    • TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN

                    • Dissoloves in any beverage
                    • Sugar Free

                      • 14

                      ONCE-DAILY

                      DOSES

                      NET WT 8.3 OZ (238 g)

                      238 G CAN

                      NDC 64380-762-05

                      Original

                      Prescription

                      Strength

                      Polyethylene Glycol 3350

                      Powder for Solution

                      Osmotic Laxative

                      • Relieves Occasional Constipation (Irregularity)
                      • Softens Stool

                        • TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN

                        • Dissolves in any beverage
                        • Sugar Free

                          • 30

                          ONCE-DAILY

                          DOSES

                          NET WT 17.9 OZ (510 g)

                          510 g CAN

* Please review the disclaimer below.