FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
Active Ingredient (In Each Dose)
Polyethylene Glycol 3350, 17 g (cap filled to line)
- •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
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 (1-800-222-1222).
- •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 (white section in cap)
- •adults and children 17 years of age and older:
- •use once a day
- •fill to top of white section 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
- •store at 20°-25°C (68°-77°F)
- •tamper -evident: do not use if printed foil seal under cap is missing, open or broken
natural and artificial orange flavor, sucralose
Package/Label Principal Display Panel
Grit Free Powder
Polyethylene Glycol 3350 Powder for Solution
• Relieves Occasional Constipation/Irregularity
• Softens Stool
Compare to active ingredient of MiraLAX®
NET WT 17.9 OZ (510 g) 30 Once-Daily Doses
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