SPL v3
SPL
SPL Set ID c4cae70c-68da-0bbc-e053-2a95a90a395a
Route
ORAL
Published
Effective Date 2021-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol 3350 (17 g)
Inactive Ingredients
Sodium Hydroxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2021-06-18

Description

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

Purpose

Osmotic Laxative


Medication Information

Purpose

Osmotic Laxative

Description

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

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.

Do not use if you have kidney disease, except under the advice and supervision of a doctor

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.
  • adults and children 17 years of age and older:
  • use once a day
  • fill to top of line 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

Active Ingredient

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

Other Information

  • store at 20°- 25°C (68°– 77°F)
  • tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
Inactive Ingredients

None

Questions Or Comments?

1-866-403-7592

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 the 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

When using this product you may have loose, watery, more frequent stools

Package Label Principal Display Panel

NDC: 68001-505-55

Original Prescription Strength

Polyethylene Glycol 3350

Powder for Solution, 17g/dose

Osmotic Laxative

14 ONCE-DAILY DOSES

NET WT 8.3 OZ (238 g)


Structured Label Content

Use (USE)

  • Relieves occasional constipation (irregularity)
  • Generally produces a bowel movement in 1 to 3 days
Purpose (PURPOSE)

Osmotic Laxative

Warnings (WARNINGS)

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

Do not use if you have kidney disease, except under the advice and supervision of a doctor

Directions (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.
  • adults and children 17 years of age and older:
  • use once a day
  • fill to top of line 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

Active Ingredient (ACTIVE INGREDIENT)

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

Other Information (OTHER INFORMATION)

  • store at 20°- 25°C (68°– 77°F)
  • tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
Inactive Ingredients (INACTIVE INGREDIENTS)

None

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-866-403-7592

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, ask a health professional before use.

Keep Out of the Reach of Children (KEEP OUT OF THE 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 taking a prescription drug

When using this product you may have loose, watery, more frequent stools

Package Label Principal Display Panel (Package Label - Principal Display Panel)

NDC: 68001-505-55

Original Prescription Strength

Polyethylene Glycol 3350

Powder for Solution, 17g/dose

Osmotic Laxative

14 ONCE-DAILY DOSES

NET WT 8.3 OZ (238 g)


Advanced Ingredient Data


Raw Label Data

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