FDA Label for Polyethylene Glycol 3350

The following document was submitted to the FDA by the labeler of this product Camber Consumer Care 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 (In Each Dose)

(Bottle Only)            


Polyethylene Glycol 3350, 17 g (cap filled to line)


(Packet Only)            


Polyethylene Glycol 3350, 17 g 

Purpose

Osmotic 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

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.

Directions

(Bottle Only)

•  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:
   • 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
   • ensure that the powder is fully dissolved before drinking 
   • do not drink if there are any clumps
   • use once a day
   • use no more than 7 days
• children 16 years of age or under: ask a doctor

  (Packet Only)

• do not take more than directed unless advised by your doctor
• adults and children 17 years of age and older:
  • stir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
  • ensure that the powder is fully dissolved before drinking 
  • do not drink if there are any clumps
  • use once a day
  • use no 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 Or Comments?

call 1-888-588-1418.

Principal Display Panel

Polyethylene glycol 3350 powder for oral solution carton label

polyethylene - polyethylene

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