FDA Label for Polyethylene Gycol 3350
View Indications, Usage & Precautions
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREASTFEEDING,
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS/COMMENTS
- PRINCIPAL DISPLAY PANEL
Polyethylene Gycol 3350 Product Label
The following document was submitted to the FDA by the labeler of this product Allegiant Health. 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.
Active Ingredient(S)
Polyethylene Glycol 3350, 17 g (cap filled to line)
Purpose
Osmotic Laxative
Use(S)
- 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
- 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 Breastfeeding,
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 (1-800-222-1222) 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 (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 difficult 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
Other Information
- store at 20° to 25°C (68° to 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/Comments
Call 1-888-952-0050 Monday through Friday 9AM - 5PM EST
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