Equate 44-726

Equate 44-726
SPL v8
SPL
SPL Set ID 0347c934-1e85-4f8d-8d35-bb07f16810ad
Route
ORAL
Published
Effective Date 2025-03-08
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 2019-10-28

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?

1-888-287-1915

Principal Display Panel

NDC 49035-906-03

equate™

Compare

to MiraLAX®

active

ingredient*

Mix-In

Laxative 

Packets

Polyethylene Glycol 3350

Powder for Solution

Osmotic Laxative

• Relieves occasional

  constipation

  (irregularity)

• Softens stool

• Dissolves in any

  beverage

10 PACKETS

NET WT 0.5 OZ

(17 g) EACH

10

ONCE-DAILY

DOSES

TAMPER-EVIDENT: DO NOT USE

IF FOIL IS OPEN OR BROKEN

Satisfaction guaranteed - or we'll replace it or give you your money

back. For questions or comments or to report and undesired reaction

or side effect, please call 1-888-287-1915

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

PRODUCT OF INDIA

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

owner of the registered trademark MiraLAX®.      50844       REV0222B72603

equate 44-726
When Using This Product

you may have loose, watery, more frequent stools

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

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?)

1-888-287-1915

Principal Display Panel (Principal display panel)

NDC 49035-906-03

equate™

Compare

to MiraLAX®

active

ingredient*

Mix-In

Laxative 

Packets

Polyethylene Glycol 3350

Powder for Solution

Osmotic Laxative

• Relieves occasional

  constipation

  (irregularity)

• Softens stool

• Dissolves in any

  beverage

10 PACKETS

NET WT 0.5 OZ

(17 g) EACH

10

ONCE-DAILY

DOSES

TAMPER-EVIDENT: DO NOT USE

IF FOIL IS OPEN OR BROKEN

Satisfaction guaranteed - or we'll replace it or give you your money

back. For questions or comments or to report and undesired reaction

or side effect, please call 1-888-287-1915

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

PRODUCT OF INDIA

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

owner of the registered trademark MiraLAX®.      50844       REV0222B72603

equate 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 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

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

All Sections (JSON)