Polyethylene Glycol 3350 Powder For Oral Solution

Polyethylene Glycol 3350 Powder For Oral Solution
SPL v3
SPL
SPL Set ID 02a44a41-0039-f6ec-e063-6394a90ae6f1
Route
ORAL
Published
Effective Date 2025-03-12
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 2024-09-04

Description

Active ingredient (in each dose) Polyethylene Glycol 3350, USP 17 grams (cup filled to the indicated 17 grams line)

Purpose

Osmotic Laxative


Medication Information

Purpose

Osmotic Laxative

Description

Active ingredient (in each dose) Polyethylene Glycol 3350, USP 17 grams (cup filled to the indicated 17 grams line)

Use
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days
Section 50567-7

When using this product you may have loose, watery, more frequent stools

Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug

Section 50570-1

Do not use if you have kidney disease, except under the advice and supervision of a doctor

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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
  • this product is supplied with a dosing cup marked to contain 17 grams of powder when filled to the indicated line
  • adults and children 17 years of age and older:
    • use once a day
    • fill to the indicated 17 grams line on cup which is marked to indicate the correct dose 17 grams
    • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    • do not combine with 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 no more than 7 days
  • children 16 years of age or under: ask a doctor
Drug Facts

Active ingredient (in each dose)



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

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 Ingredients

none



Questions or comments?



call 1-855-274-4122



DISTRIBUTED BY:

MIDWOOD BRANDS, LLC

500 VOLVO PKWY

CHESAPEAKE, VA 23320 USA



MADE IN INDIA



Code: TS/DRUGS/16/2014

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
Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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
Package Label Principal Display Panel 119 G Bottle Label

FAMILY

WellnessTM

COMPARE TO THE ACTIVE

INGREDIENT OF MIRALAX®*

COMFORTLAX®                                                UNFLAVORED

Polyethylene Glycol 3350                                         POWDER -

Powder for Oral Solution                                        GRIT FREE

Osmotic Laxative

• Relieves Occasional Constipation/Irregularity

• Softens Stool

7 ONCE-DAILY DOSES

NET WT 4.1 OZ (119 g)                               NDC 55319-056-24


Structured Label Content

Use
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days
Section 50567-7 (50567-7)

When using this product you may have loose, watery, more frequent stools

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug

Section 50570-1 (50570-1)

Do not use if you have kidney disease, except under the advice and supervision of a doctor

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

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
  • this product is supplied with a dosing cup marked to contain 17 grams of powder when filled to the indicated line
  • adults and children 17 years of age and older:
    • use once a day
    • fill to the indicated 17 grams line on cup which is marked to indicate the correct dose 17 grams
    • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    • do not combine with 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 no more than 7 days
  • children 16 years of age or under: ask a doctor
Drug Facts

Active ingredient (in each dose)



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

Other Information (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 Ingredients (Inactive ingredients)

none



Questions or comments?



call 1-855-274-4122



DISTRIBUTED BY:

MIDWOOD BRANDS, LLC

500 VOLVO PKWY

CHESAPEAKE, VA 23320 USA



MADE IN INDIA



Code: TS/DRUGS/16/2014

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
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 (1-800-222-1222) right away.

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
Package Label Principal Display Panel 119 G Bottle Label (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 119 g Bottle Label)

FAMILY

WellnessTM

COMPARE TO THE ACTIVE

INGREDIENT OF MIRALAX®*

COMFORTLAX®                                                UNFLAVORED

Polyethylene Glycol 3350                                         POWDER -

Powder for Oral Solution                                        GRIT FREE

Osmotic Laxative

• Relieves Occasional Constipation/Irregularity

• Softens Stool

7 ONCE-DAILY DOSES

NET WT 4.1 OZ (119 g)                               NDC 55319-056-24


Advanced Ingredient Data


Raw Label Data

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