Polyethylene Glycol 3350 Powder For Oral Solution

SPL v4

SPL

SPL Set ID 04cc4f2e-1725-4710-8cfb-73a6bdf52e4f

Route

ORAL

Published

Effective Date 2025-12-12

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 2024-11-08

Description

Active ingredient (in each dose) Polyethylene Glycol 3350, USP 17 grams

Purpose

Osmotic Laxative

Medication Information

Purpose

Osmotic Laxative

Description

Active ingredient (in each dose) Polyethylene Glycol 3350, USP 17 grams

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
adults and children 17 years of age and older:
- use once a day
- stir and dissolve one packet of powder (17 g) 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 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

Other Information

store at 20° to 25°C (68° to 77°F)
tamper-evident: do not use if foil is open or broken

Inactive Ingredients

none

Questions or comments?

call 1-855-274-4122

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Essential to Care™ since 1979

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 17 G Pouch Label

LEADER_TM

NDC 70000-0699-1

Grit-Free | Unflavored Powder Packet

Polyethylene

Glycol 3350

Powder for Oral Solution

Osmotic Laxative

Relieves Occasional

Constipation/Irregularity

Softens Stool

Sugar-Free

Dissolves in any Beverage

COMPARE TO

MiraLAX^®

active ingredient*

100% Money

Back Guarantee

1 DOSE

NET WT 0.5 OZ (17g)

Package Label Principal Display Panel 17 G Pouch Carton Label

LEADER_TM

NDC 70000-0699-2

Grit-Free | Unflavored Powder Packets

Polyethylene Glycol 3350

Powder for Oral Solution | Osmotic Laxative

Relieves Occasional Constipation/Irregularity

Softens Stool

Sugar-Free

Dissolves in Any Beverage

COMPARE TO

MiraLAX^®

active ingredient*

100% Money

Back Guarantee

10 PRE-MEASURED, SINGLE DOSES 10 PACKETS

10 ONCE-DAILY DOSES NET WT 0.5 OZ (17g) EACH

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
adults and children 17 years of age and older:
- use once a day
- stir and dissolve one packet of powder (17 g) 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 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

Other Information (Other information)

store at 20° to 25°C (68° to 77°F)
tamper-evident: do not use if foil is open or broken

Inactive Ingredients (Inactive ingredients)

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 17 G Pouch Label (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Pouch Label)

LEADER_TM

Package Label Principal Display Panel 17 G Pouch Carton Label (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Pouch Carton Label)

LEADER_TM

Advanced Ingredient Data

[{"name": "POLYETHYLENE GLYCOL 3350", "unii": "G2M7P15E5P", "classCode": "ACTIB", "strengthNumerator": "17", "strengthDenominator": "17", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Use": "relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days", "50567-7": "When using this product you may have loose, watery, more frequent stools", "50568-5": "Ask a doctor or pharmacist before use if you are taking a prescription drug", "50570-1": "Do not use if you have kidney disease, except under the advice and supervision of a doctor", "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 adults and children 17 years of age and older: use once a day stir and dissolve one packet of powder (17 g) 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 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", "Other information": "store at 20° to 25°C (68° to 77°F) tamper-evident: do not use if foil is open or broken", "Inactive ingredients": "none Questions or comments? call 1-855-274-4122 DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 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 - 17 g Pouch Label": "LEADER TM NDC 70000-0699-1 Grit-Free | Unflavored Powder Packet Polyethylene Glycol 3350 Powder for Oral Solution Osmotic Laxative Relieves Occasional Constipation/Irregularity Softens Stool Sugar-Free Dissolves in any Beverage COMPARE TO MiraLAX ® active ingredient* 100% Money Back Guarantee 1 DOSE NET WT 0.5 OZ (17g)", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Pouch Carton Label": "LEADER TM NDC 70000-0699-2 Grit-Free | Unflavored Powder Packets Polyethylene Glycol 3350 Powder for Oral Solution | Osmotic Laxative Relieves Occasional Constipation/Irregularity Softens Stool Sugar-Free Dissolves in Any Beverage COMPARE TO MiraLAX ® active ingredient* 100% Money Back Guarantee 10 PRE-MEASURED, SINGLE DOSES 10 PACKETS 10 ONCE-DAILY DOSES NET WT 0.5 OZ (17g) EACH"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:17.489276 · Updated: 2026-03-14T23:12:28.058882