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Polyethylene Glycol 3350, NF Powder for Solution, Laxative

Dosage form: powder, for solution
Ingredients: POLYETHYLENE GLYCOL 3350 17g in 1d
Labeler: Nexgen Pharma, Inc.
NDC Code: 0722-7116

Drug Facts

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

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
  • 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 Label

9 oz Container Label

4 oz Principal Display Panel; Drug Facts on ECL

POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE 
polyethylene glycol 3350, nf powder for solution, laxative powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0722-7116(NDC:00722-7116)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) POLYETHYLENE GLYCOL 335017 g  in 1 d
Packaging
#Item CodePackage Description
1NDC:0722-7116-017 d in 1 BOTTLE
2NDC:0722-7116-0214 d in 1 BOTTLE
3NDC:0722-7116-0330 d in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09081210/07/2009
Labeler - Nexgen Pharma, Inc. (048488621)

Revised: 10/2009
 
Nexgen Pharma, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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