Winco Polyethylene Glycol 3350 Drug Fact

SPL v3

SPL

SPL Set ID d649f758-a46f-4864-8718-878ee5a74bfc

Route

ORAL

Published

Effective Date 2023-09-07

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 2023-08-21

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 50565-1

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this productyou may have loose, watery, more frequent stools

Section 50568-5

Ask a doctor of 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.

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 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

Allergy Alert

Do not use if you are allergic to polyethylene glycol

Other Information

•
store at 20°-25°C (68°-77°F)

Inactive Ingredients

none

Questions Or Comments?

1-866-467-2748

TAMPER-EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP, PRINTED WITH "SEALED FOR YOUR PROTECTION" IS MISSING, OPEN OR BROKEN

Principal Display Panel

*Compare to the active ingredient in MiraLAX®

NDC 67091-447-08

Polyethylene Glycol 3350,

Powder for Solution,

Osmotic Laxative

•
Relieves Occasional Constipation/Irregularity
•
Softens Stool

UNFLAVORED POWDER

14 ONCE-DAILY DOSES

NET WT 8.3 OZ (238 g)

•
Dissolves in Any Beverage

DISTRIBUTED BY: WINCO FOODS, LLC

BOISE, ID, 83704

*This product is not manufactured or distributed by Bayer HealthCare LLC, the distributer of MiraLAX®

Stop Use and Ask A Doctor If

•
you have rectal bleeding or your nausea, bloating or 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

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

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 50565-1 (50565-1)

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this productyou may have loose, watery, more frequent stools

Section 50568-5 (50568-5)

Ask a doctor of 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

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 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

Allergy Alert (Allergy alert)

Do not use if you are allergic to polyethylene glycol

Other Information (Other information)

•
store at 20°-25°C (68°-77°F)

Inactive Ingredients (Inactive ingredients)

none

Questions Or Comments? (Questions or comments?)

1-866-467-2748

TAMPER-EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP, PRINTED WITH "SEALED FOR YOUR PROTECTION" IS MISSING, OPEN OR BROKEN

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

*Compare to the active ingredient in MiraLAX®

NDC 67091-447-08

Polyethylene Glycol 3350,

Powder for Solution,

Osmotic Laxative

•
Relieves Occasional Constipation/Irregularity
•
Softens Stool

UNFLAVORED POWDER

14 ONCE-DAILY DOSES

NET WT 8.3 OZ (238 g)

•
Dissolves in Any Beverage

DISTRIBUTED BY: WINCO FOODS, LLC

BOISE, ID, 83704

*This product is not manufactured or distributed by Bayer HealthCare LLC, the distributer of MiraLAX®

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

•
you have rectal bleeding or your nausea, bloating or 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

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

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", "42229-5": "Drug Facts", "50565-1": "Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50567-7": "When using this product you may have loose, watery, more frequent stools", "50568-5": "Ask a doctor of 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", "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 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", "Allergy alert": "Do not use if you are allergic to polyethylene glycol", "Other information": "• store at 20°-25°C (68°-77°F)", "Inactive ingredients": "none", "Questions or comments?": "1-866-467-2748 TAMPER-EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP, PRINTED WITH "SEALED FOR YOUR PROTECTION" IS MISSING, OPEN OR BROKEN", "PRINCIPAL DISPLAY PANEL": "*Compare to the active ingredient in MiraLAX® NDC 67091-447-08 Polyethylene Glycol 3350 , Powder for Solution , Osmotic Laxative • Relieves Occasional Constipation/Irregularity • Softens Stool UNFLAVORED POWDER 14 ONCE-DAILY DOSES NET WT 8.3 OZ (238 g) • Dissolves in Any Beverage DISTRIBUTED BY: WINCO FOODS, LLC BOISE, ID, 83704 *This product is not manufactured or distributed by Bayer HealthCare LLC, the distributer of MiraLAX®", "Stop use and ask a doctor if": "• you have rectal bleeding or your nausea, bloating or 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", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:53.035969 · Updated: 2026-03-14T23:08:19.346855