FDA Label for Polyethylene Glycol 3350, Nf Powder For Solution, Laxative
View Indications, Usage & Precautions
Polyethylene Glycol 3350, Nf Powder For Solution, Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Nexgen Pharma, 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.
Active Ingredient
Polyethylene Glycol 3350, 17g (cap filled to the top)
Purpose
Laxative
Uses
- 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 you have
- nausea, vomiting or abdominal pain
- a sudden change in bowel habits that lasts over 2 weeks
- irritable bowel syndrome
- 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
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
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 cup designed to contain 17 grams of powder when filled to the top rim.
- adults and children 17 years of age and older
- fill to the top of the bottle cap which will provide 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 younger, ask a doctor
Other Information
- Store at 20O - 25O C (68O - 77O 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 Or Comments?
For serious adverse events call:
1-888-710-0006
Principal Display
17.9 Oz Container Label9 oz Container Label4 oz Principal Display Panel; Drug Facts on ECL
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