Polyethylene Glycol 3350 Powder, For Solution
FDA Label NDC 59556-762

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Strides Pharma Inc for the product Polyethylene Glycol 3350 (NDC 59556-762). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding polyethylene glycol 3350, powder for solution, active ingredient (in each dose) (can only), purpose, active ingredient (in each dose) (packet only), use, allergy alert, otc - do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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