Polyethylene Glycol 3350, Powder For Solution

Polyethylene Glycol 3350, Powder For Solution
SPL v5
SPL
SPL Set ID 5d0d2c14-24e6-45b4-92f6-4eaf5da72cdd
Route
ORAL
Published
Effective Date 2022-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol 3350 (17 g)

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2022-10-27

Description

Drug Facts

Purpose

Osmotic Laxative


Medication Information

Purpose

Osmotic Laxative

Description

Drug Facts

Use
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days
Section 42229-5

Drug Facts

Section 53413-1

Questions or comments?

1-800-540-3765

Manufactured for:

Geri-Care Pharmaceuticals

1295 Townbin Ave. Lakewood, NJ 08701

Product of India

Issued: 07/2022

Directions
  • 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:
    • use once a day
    • 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
    • do not combine with the 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 more than 7 days
  • children 16 years of age or under: ask a doctor
Do Not Use

if you have kidney disease, except under the advice and supervision of a doctor

Allergy Alert

Do not use if you are allergic to polyethylene glycol

Other Information
  • store at 20° - 25°C (68° - 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

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.

Keep Out of Reach of Childreen

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

Active Ingredient (in Each Dose)

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

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

Package Label.principal Display Panel

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

NDC 57896-490-01

1 DOSE

NET WT 0.5 OZ (17 g)

NDC 57896-490-03

30 PACKETS

NET WT 0.5 OZ (17 g) Each

NDC 57896-490-07

7 ONCE-DAILY DOSES

NET WT 4.15 OZ (119 g)

NDC 57896-490-14

14 ONCE-DAILY DOSES

NET WT 8.3 OZ (238 g)

NDC 57896-490-30

30 ONCE-DAILY DOSES

NET WT 17.9 OZ (510 g)

NDC 57896-490-45

45 ONCE-DAILY DOSES

NET WT 26.9 OZ (765 g)


Structured Label Content

Use
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days
Section 42229-5 (42229-5)

Drug Facts

Section 53413-1 (53413-1)

Questions or comments?

1-800-540-3765

Manufactured for:

Geri-Care Pharmaceuticals

1295 Townbin Ave. Lakewood, NJ 08701

Product of India

Issued: 07/2022

Purpose

Osmotic Laxative

Directions
  • 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:
    • use once a day
    • 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
    • do not combine with the 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 more than 7 days
  • children 16 years of age or under: ask a doctor
Do Not Use (Do not use)

if you have kidney disease, except under the advice and supervision of a doctor

Allergy Alert (Allergy alert)

Do not use if you are allergic to polyethylene glycol

Other Information
  • store at 20° - 25°C (68° - 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 (Inactive ingredients)

none

When Using This Product (When using this product)

you may have loose, watery, more frequent stools

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Childreen (Keep out of reach of childreen)

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

Active Ingredient (in Each Dose) (Active ingredient (in each dose))

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

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use)

if you are taking a prescription drug

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

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

NDC 57896-490-01

1 DOSE

NET WT 0.5 OZ (17 g)

NDC 57896-490-03

30 PACKETS

NET WT 0.5 OZ (17 g) Each

NDC 57896-490-07

7 ONCE-DAILY DOSES

NET WT 4.15 OZ (119 g)

NDC 57896-490-14

14 ONCE-DAILY DOSES

NET WT 8.3 OZ (238 g)

NDC 57896-490-30

30 ONCE-DAILY DOSES

NET WT 17.9 OZ (510 g)

NDC 57896-490-45

45 ONCE-DAILY DOSES

NET WT 26.9 OZ (765 g)


Advanced Ingredient Data


Raw Label Data

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