Major 44-726

Major 44-726
SPL v10
SPL
SPL Set ID ddc9d2b1-87d8-44fa-bac6-0a7261f33564
Route
ORAL
Published
Effective Date 2025-05-29
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 2019-06-30

Description

Polyethylene Glycol 3350, 17 g

Purpose

Osmotic Laxative


Medication Information

Purpose

Osmotic Laxative

Description

Polyethylene Glycol 3350, 17 g

Use
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days
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
Do Not Use

if you have kidney disease, except under the advice and supervision of a doctor

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

none

Questions Or Comments?

1-800-616-2471

Principal Display Panel

NDC 0904-6931-26

Compare to MiraLAX®

active ingredient*

MAJOR®

PEG3350

Polyethylene Glycol 3350

Powder for Oral Solution

Osmotic Laxative

• Relieves Occasional Constipation (Irregularity)

• Softens Stool

Dissolves in Any Beverage

Sugar Free

Unflavored

14 Once-Daily Doses

NET WT 0.5 OZ (17 g) Each

TAMPER-EVIDENT: DO NOT USE IF

FOIL IS OPEN OR BROKEN

*This product is not manufactured or distributed by Bayer HealthCare LLC,

owner of the registered trademark MiraLAX®.

Distributed by MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

www.majorpharmaceuticals.com

Rev. 03/22                             M-17                              Re-order No. 701066

Product of India                                                      50844      REV0222D72648

Major 44-726
When Using This Product

you may have loose, watery, more frequent stools

Stop Use and Ask A Doctor If
  • you get diarrhea
  • you need to use a laxative for longer than 1 week
  • you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition.
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Dose)

Polyethylene Glycol 3350, 17 g

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
Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug


Structured Label Content

Use
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days
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
Do Not Use (Do not use)

if you have kidney disease, except under the advice and supervision of a doctor

Other Information (Other information)
  • store at 20° - 25°C (68° - 77°F)
  • tamper-evident: do not use if foil is open or broken
Inactive Ingredients (Inactive ingredients)

none

Questions Or Comments? (Questions or comments?)

1-800-616-2471

Principal Display Panel (Principal display panel)

NDC 0904-6931-26

Compare to MiraLAX®

active ingredient*

MAJOR®

PEG3350

Polyethylene Glycol 3350

Powder for Oral Solution

Osmotic Laxative

• Relieves Occasional Constipation (Irregularity)

• Softens Stool

Dissolves in Any Beverage

Sugar Free

Unflavored

14 Once-Daily Doses

NET WT 0.5 OZ (17 g) Each

TAMPER-EVIDENT: DO NOT USE IF

FOIL IS OPEN OR BROKEN

*This product is not manufactured or distributed by Bayer HealthCare LLC,

owner of the registered trademark MiraLAX®.

Distributed by MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

www.majorpharmaceuticals.com

Rev. 03/22                             M-17                              Re-order No. 701066

Product of India                                                      50844      REV0222D72648

Major 44-726
When Using This Product (When using this product)

you may have loose, watery, more frequent stools

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you get diarrhea
  • you need to use a laxative for longer than 1 week
  • you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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 right away.

Active Ingredient (in Each Dose) (Active ingredient (in each dose))

Polyethylene Glycol 3350, 17 g

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
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking a prescription drug


Advanced Ingredient Data


Raw Label Data

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