Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID d6218f65-1b41-417e-b928-56ac6db411af
Route
ORAL
Published
Effective Date 2019-09-04
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 2009-10-07

Description

Polyethylene Glycol 3350, 17 grams (cap filled to the top)

Purpose

Osmotic Laxative


Medication Information

Purpose

Osmotic Laxative

Description

Polyethylene Glycol 3350, 17 grams (cap filled to the top)

Uses
  • 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.

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.

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.

Directions
  • Do not take more than directed unless advised by your doctor.
  • The bottle cap is a measuring cup designed to contain 17 grams of powder when filled to the top rim.
  • Adults and children 17 years of age and older:
    • Fill to the top of the bottle cap which will provide the correct dose (17 g).
    • Stir and dissolve in any 4 to 8 ounces of beverage (cold, hot, or room temperature), then drink.
    • Ensure that the powder is fully dissolved before drinking.
    • Do not drink if there are any clumps.
    • Use once a day.
    • Use no more than 7 days.

Children 16 years of age or younger, ask a doctor.

Other Information
  • Store at 20°C – 25°C (68°F – 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?

For serious adverse events call Nexgen Pharma, Inc. at 1-888-710-0006 or contact online at www.nexgenpharma.com.

Manufactured by: Nexgen Pharma, Inc., Irvine, CA 92606, USA

Rev. 09/2019

Keep Out of Reach of Children

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

Label Principal Display Panel

17.9 oz Container Label

Active Ingredient (in Each Dose)

Polyethylene Glycol 3350, 17 grams (cap filled to the top)


Structured Label Content

Uses
  • 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.

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

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.

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.

Directions
  • Do not take more than directed unless advised by your doctor.
  • The bottle cap is a measuring cup designed to contain 17 grams of powder when filled to the top rim.
  • Adults and children 17 years of age and older:
    • Fill to the top of the bottle cap which will provide the correct dose (17 g).
    • Stir and dissolve in any 4 to 8 ounces of beverage (cold, hot, or room temperature), then drink.
    • Ensure that the powder is fully dissolved before drinking.
    • Do not drink if there are any clumps.
    • Use once a day.
    • Use no more than 7 days.

Children 16 years of age or younger, ask a doctor.

Other Information
  • Store at 20°C – 25°C (68°F – 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?)

For serious adverse events call Nexgen Pharma, Inc. at 1-888-710-0006 or contact online at www.nexgenpharma.com.

Manufactured by: Nexgen Pharma, Inc., Irvine, CA 92606, USA

Rev. 09/2019

Keep Out of Reach of Children

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

Label Principal Display Panel

17.9 oz Container Label

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

Polyethylene Glycol 3350, 17 grams (cap filled to the top)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)