Polyethylene Glycol-3350

Novel Laboratories, Inc.
Novel Laboratories, Inc.

Polyethylene Glycol 3350, Powder for Oral Solution

FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient (in each dose)..........................................Purpose

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

Use

• relieves occasional constipation (irregularity)

• generally produces a bowel movement in 1 to 3 days

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

• side effects occur. You may report side effects to FDA at 1-800-FDA-1088

Drug Facts (continued)

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 cap marked to contain 17 grams of powder when filled to the indicated line.

• adults and children 17 years of age and older:

  • 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

  • use once a day

  • use no more than 7 days

• children 16 years of age or under: ask a doctor

Other Information

• store at 20° - 25°C (68°– 77°F)

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

Inactive Ingredients                             none

Questions or comments?

1-800-FDA-1088 (1-800-332-1088) or www.fda.gov