Dulcolax Powder

Dulcolax Powder
SPL v1
SPL
SPL Set ID ed16d0f4-74e7-4fa3-989d-c6840a5d3e71
Route
ORAL
Published
Effective Date 2025-09-30
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 2025-09-30

Description

Dulcolax Powder Drug Facts

Purpose

Osmotic Laxative


Medication Information

Purpose

Osmotic Laxative

Description

Dulcolax Powder Drug Facts

Use
  • relieves occasional constipation (irregularity)

  • generally produces a bowel movement in 1 to 3 days
Stop
  • 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
Other
  • store at 20°-25°C (68°-77°F)

  • tamper-evident: do not use if printed foil seal under cap is missing, open or broken
Section 42229-5

Dulcolax Powder

Drug Facts

Inactive

none

Warnings

Allergy alert: Do not use if you are allergic to polyethylene glycol

Questions

1- 866-844-2798

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 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

Active Ingredient

Polyethylene Glycol 3350, 17 g (cap filled to line)

Principal Display Panel

Dulcolax ®

Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative


POWDER


NET WT 26.9 oz (765 g)


45 ONCE-DAILY


DOSES

When Using This Product

you may have loose, watery, more frequent stools

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 (1-800-222-1222).

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
Stop
  • 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
Other
  • store at 20°-25°C (68°-77°F)

  • tamper-evident: do not use if printed foil seal under cap is missing, open or broken
Section 42229-5 (42229-5)

Dulcolax Powder

Drug Facts

Purpose

Osmotic Laxative

Inactive

none

Warnings

Allergy alert: Do not use if you are allergic to polyethylene glycol

Questions

1- 866-844-2798

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 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

Active Ingredient (Active ingredient)

Polyethylene Glycol 3350, 17 g (cap filled to line)

Principal Display Panel

Dulcolax ®

Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative


POWDER


NET WT 26.9 oz (765 g)


45 ONCE-DAILY


DOSES

When Using This Product (When using this product)

you may have loose, watery, more frequent stools

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 (1-800-222-1222).

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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