Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 7546518f-b90f-477f-8f94-9ed76f98f1d7
Route
ORAL
Published
Effective Date 2009-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol 3350 (17 g)
Inactive Ingredients
Air

Identifiers & Packaging

Marketing Status
ANDA Active Since 2009-10-07

Description

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

Purpose

Laxative


Medication Information

Purpose

Laxative

Description

Polyethylene Glycol 3350, 17g (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.

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

Directions
  • do not take more than directed unless advised by your doctor
  • The bottle top 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.
    • use once a day
    • use no more than 7 days
  • children 16 years of age or younger, ask a doctor
Active Ingredient

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

Other Information
  • Store at 20O - 25O C (68O - 77O F)
  • tamper-evident: do not use if foil seal under cap, printed with “SEALED FOR YOUR PROTECTION” is missing, open or broken.
Principal Display
Inactive Ingredients

None

Questions Or Comments?

For serious adverse events call: 

1-888-710-0006


Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 1 to 3 days
Purpose

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.

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

Directions
  • do not take more than directed unless advised by your doctor
  • The bottle top 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.
    • use once a day
    • use no more than 7 days
  • children 16 years of age or younger, ask a doctor
Active Ingredient (Active ingredient)

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

Other Information
  • Store at 20O - 25O C (68O - 77O F)
  • tamper-evident: do not use if foil seal under cap, printed with “SEALED FOR YOUR PROTECTION” is missing, open or broken.
Principal Display
Inactive Ingredients (Inactive ingredients)

None

Questions Or Comments? (Questions or Comments?)

For serious adverse events call: 

1-888-710-0006


Advanced Ingredient Data


Raw Label Data

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