FDA Label for Polyethylene Glycol-3350
View Indications, Usage & Precautions
Polyethylene Glycol-3350 Product Label
The following document was submitted to the FDA by the labeler of this product Novel Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
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
Warnings
Allergy alert: Do not use if you are allergic to polyethylene glycol
Otc - Do Not Use
Do not use if you have kidney disease, except under the advice and supervision of a doctor
Otc - Ask 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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking a prescription drug
Otc - When Using
When using this product you may have loose, watery, more frequent stools
Otc - Stop Use
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)
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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.
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
store at 20° - 25°C (68°– 77°F)
tamper-evident: do not use if printed foil seal under cap is missing, open or broken
Other Information
Inactive Ingredient
Inactive Ingredients none
Otc - Questions
Questions or comments?
1-800-FDA-1088 (1-800-332-1088) or www.fda.gov
Package Label.Principal Display Panel
* Please review the disclaimer below.
