Polyethylene Glycol 3350

Polyethylene Glycol 3350
SPL v2
SPL
SPL Set ID 5d2b2570-444b-4263-b339-bd81171979d6
Route
ORAL
Published
Effective Date 2019-05-21
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 2019-04-01

Description

MARLEX PHARMACEUTICAL S , INC ---------- Polyethylene Glycol 3350 powder, for solution Drug Facts

Purpose

Osmotic Laxative


Medication Information

Purpose

Osmotic Laxative

Description

MARLEX PHARMACEUTICAL S , INC ---------- Polyethylene Glycol 3350 powder, for solution Drug Facts

Use
  • relieves occasional constipation (irregularity) generally

  • produces a bowel movement in 1 to 3 days
Section 42229-5

MARLEX PHARMACEUTICAL S , INC

----------

Polyethylene Glycol 3350 powder, for solution

Drug Facts

Warnings

Allergy alert:

Do not use if you are allergic to polyethylene glycol

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 (clear section in cap)

  • adults and children 17 years of age and older:

    ○ fill to top of clear 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
Do Not Use

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

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 Ingredient

none

Questions Or Comments?

1-800-FDA-1088

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev. 04/19IT

Principal Display Panel

NDC 10135-0683-04

Polyethylene Glycol

3350

Powder for Solution, Osmotic Laxative

Net Wt 4.1 oz (119 g)

7 Once-Daily Doses

When Using This Product

you may 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 Children.

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

Active Ingredient (in Each Dose)

Polyethylene Glycol 3350, 17 g (cap filled to 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 Doctor Or Pharmacist Before Use If You Are

taking a prescription drug


Structured Label Content

Use
  • relieves occasional constipation (irregularity) generally

  • produces a bowel movement in 1 to 3 days
Section 42229-5 (42229-5)

MARLEX PHARMACEUTICAL S , INC

----------

Polyethylene Glycol 3350 powder, for solution

Drug Facts

Purpose

Osmotic Laxative

Warnings

Allergy alert:

Do not use if you are allergic to polyethylene glycol

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 (clear section in cap)

  • adults and children 17 years of age and older:

    ○ fill to top of clear 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
Do Not Use (Do not use)

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

Other Information (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 Ingredient (Inactive ingredient)

none

Questions Or Comments? (Questions or comments?)

1-800-FDA-1088

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev. 04/19IT

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 10135-0683-04

Polyethylene Glycol

3350

Powder for Solution, Osmotic Laxative

Net Wt 4.1 oz (119 g)

7 Once-Daily Doses

When Using This Product (When using this product)

you may 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 Children. (Keep out of reach of children.)

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 g (cap filled to 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 Doctor Or Pharmacist Before Use If You Are (Ask doctor or pharmacist before use if you are)

taking a prescription drug


Advanced Ingredient Data


Raw Label Data

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