Polyethylene Glycol 3350, NF Powder for Solution, Laxative description, usages, side effects, indications, overdosage, supplying and lots more!

Polyethylene Glycol 3350, NF Powder for Solution, Laxative

Nexgen Pharma, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

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 Type Human otc drug label Item Code (Source) NDC:0722-7116(NDC:00722-7116)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
POLYETHYLENE GLYCOL 3350 17 g

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0722-7116-01 7 in 1 BOTTLE
2 NDC:0722-7116-02 14 in 1 BOTTLE
3 NDC:0722-7116-03 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090812 2009-10-07


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