Inactive Ingredients
Inactive Ingredients none
Peg 3350
FDA Label NDC 50090-2526
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Peg 3350 (NDC 50090-2526). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding inactive ingredients, active ingredient, purpose, warnings, ask doctor, stop use, keep out of reach of children, pregnancy warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Active Ingredient (in each dose)
Polyethylene Glycol 3350, 17 g (cap filled to line)
Purpose
Purpose
Osmotic Laxative
Warnings
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
When using this product, you may have loose, watery, more frequent bowel movements
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
Ask a doctor or pharmacist before use if you are taking a prescription drug
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 sogns of a serious condition.
- you get diarrhea
- you need to use a laxative for longer than 1 week
- side effects occur
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.
Pregnancy Warning
If pregnant or breast-feeding, ask a health professional before use.
Dosage And Administration
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) and then drink
-use once a day
-use no more than 7 days
-Children 16 years of age or under: ask a doctor
Questions?
Questions or comments?
1-800-645-2158
Indications And Usage
Use
-relieves occasional constipation (irregularity)
-generally produces a bowel movement in 1 to 3 days
How Supplied
Product: 50090-2526
NDC: 50090-2526-0 238 g in a BOTTLE
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