Drug Mart Polyethylene Glycol 3350 Drug Fact

Drug Mart Polyethylene Glycol 3350 Drug Fact
SPL v3
SPL
SPL Set ID 9dc3679f-22b3-4f0c-ba06-9ffa875799e7
Route
ORAL
Published
Effective Date 2025-03-24
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 2023-04-17

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 product you 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:
    • o
      use once a day
    • o
      fill to top of white section in cap which is marked to indicate the correct dose (17 g)
    • o
      stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    • o
      do not combine with starch-based thickeners used for difficulty swallowing
    • o
      ensure that the powder is fully dissolved before drinking
    • o
      do not drink if there are any clumps
    • o
      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

DISCOUNT DRUG MART

NDC 53943-652-14

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: DRUG MART-FOOD FAIR

MEDINA, OHIO 44256

www.discount-drugmart.com

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATIFACTION, NAME, ADRESS AND PACKAGE TO:

DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 044256

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

Principal Display Panel

DISCOUNT DRUG MART

NDC 53943-652-30

Polyethylene Glycol 3350,

Powder for Solution,

Osmotic Laxative

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

UNFLAVORED POWDER

30 ONCE-DAILY DOSES

NET WT 17.9 OZ (510g)

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 product you 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:
    • o
      use once a day
    • o
      fill to top of white section in cap which is marked to indicate the correct dose (17 g)
    • o
      stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    • o
      do not combine with starch-based thickeners used for difficulty swallowing
    • o
      ensure that the powder is fully dissolved before drinking
    • o
      do not drink if there are any clumps
    • o
      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)

DISCOUNT DRUG MART

NDC 53943-652-14

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: DRUG MART-FOOD FAIR

MEDINA, OHIO 44256

www.discount-drugmart.com

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATIFACTION, NAME, ADRESS AND PACKAGE TO:

DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 044256

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

Principal Display Panel

DISCOUNT DRUG MART

NDC 53943-652-30

Polyethylene Glycol 3350,

Powder for Solution,

Osmotic Laxative

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

UNFLAVORED POWDER

30 ONCE-DAILY DOSES

NET WT 17.9 OZ (510g)

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


Raw Label Data

All Sections (JSON)