peg 3350 description, usages, side effects, indications, overdosage, supplying and lots more!

peg 3350

Major Pharmaceuticals

  • 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
Major Pharmaceuticals PEG3350 Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each dose)

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

Purpose

  • Osmotic 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. (1-800-222-1222)

Directions

Directions for Bottle(s) 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
  • use once a day
  • use no more than 7 days
  • children 16 years of age or under: ask a doctor

Directions for Bottle and Pouch Configurations Only

  • do not take more than directed unless advised by your doctor
  • adults and children 17 years of age and older:

Bottle:

  • the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap)
  • 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

Pouch:

  • stir and dissolve one packet of powder (17 g) 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 under: ask a doctor

Other information

  • store at 20˚-25˚C (68˚-77˚F)
  • tamper-evident: do not use if printed foil pouch is open or broken {pouch only}
  • tamper-evident: do not use if printed foil seal under cap is missing, open or broken {bottle only}

Inactive ingredients

  • none

Questions or comments?

1-800-616-2471

Principal Display Panel

Compare to MiraLAX® active ingredient

PEG3350

ORIGINAL PRESCRIPTION STRENGTH

Polyethylene Glycol 3350

Powder for Solution

Osmotic Laxative

Relieves Occasional Constipation (Irregularity)

Softens Stool

# Once-Daily Doses {Replace "#" with the number of once daily doses}

Principal Display Panel
PEG3350 Front Label PEG3350 Back Label

peg 3350

Polyethylene Glycol 3350 POWDER, FOR SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0904-6025
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
POLYETHYLENE GLYCOL 3350 17 g

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 17 in 1 POUCH
2 NDC:0904-6025-76 510 in 1 BOTTLE
3 NDC:0904-6025-77 238 in 1 BOTTLE
4 NDC:0904-6025-84 850 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090685 2009-10-08


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