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

Purpose

Osmotic Laxative

Description

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


Medication Information

Warnings

Allergy alert: Do not use if you are allergic to polyethylene glycol

Purpose

Osmotic Laxative

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
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

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.

Drug Facts

Active ingredient (in each dose)



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

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

Warnings

Allergy alert: Do not use if you are allergic to polyethylene glycol

Purpose

Osmotic Laxative

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
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

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.

Drug Facts

Active ingredient (in each dose)



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

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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