POLYETHYLENE GLYCOL 3350 NF POLYETHYLENE GLYCOL 3350 SUNRISE PHARMACEUTICAL, INC FDA Approved Use relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days
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Route
ORAL
Applications
ANDA206105

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each dose) Polyethylene Glycol 3350 17 g (cap filled to line)
Inactive Ingredients
Inactive ingredient none
Strengths
17 g
Quantities
3350 count
Treats Conditions
Use Relieves Occasional Constipation Irregularity Generally Produces A Bowel Movement In 1 To 3 Days
Pill Appearance
Color: white

Identifiers & Packaging

Container Type UNKNOWN
UNII
G2M7P15E5P
Packaging

PRINCIPAL DISPLAY PANEL NDC 11534- 180 -19 Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative Relieves Occasional Constipation/Irregularity Softens Stool Dissolves in Any Beverage Unflavored Powder Grit Free Polyethylene Glycol 3350 increases frequency of bowel movements and softens the stool. NDC 11534- 180 -28 Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative Relieves Occasional Constipation/Irregularity Softens Stool Dissolves in Any Beverage Unflavored Powder Grit Free Polyethylene Glycol 3350 increases frequency of bowel movements and softens the stool. NDC 11534- 180 -50 Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative Relieves Occasional Constipation/Irregularity Softens Stool Dissolves in Any Beverage Unflavored Powder Grit Free Polyethylene Glycol 3350 increases frequency of bowel movements and softens the stool. 2ffddd92-figure-01 2ffddd92-figure-02 2ffddd92-figure-03

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC 11534- 180 -19 Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative Relieves Occasional Constipation/Irregularity Softens Stool Dissolves in Any Beverage Unflavored Powder Grit Free Polyethylene Glycol 3350 increases frequency of bowel movements and softens the stool. NDC 11534- 180 -28 Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative Relieves Occasional Constipation/Irregularity Softens Stool Dissolves in Any Beverage Unflavored Powder Grit Free Polyethylene Glycol 3350 increases frequency of bowel movements and softens the stool. NDC 11534- 180 -50 Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative Relieves Occasional Constipation/Irregularity Softens Stool Dissolves in Any Beverage Unflavored Powder Grit Free Polyethylene Glycol 3350 increases frequency of bowel movements and softens the stool. 2ffddd92-figure-01 2ffddd92-figure-02 2ffddd92-figure-03

Overview

Use relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days

Indications & Usage

Use relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days

Dosage & Administration

Directions 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 (clear section in cap) adults and children 17 years of age and older: ○ fill to top of clear 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

Warnings & Precautions
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
Purpose

Purpose Osmotic Laxative

When Using

When using this product you may loose, watery, more frequent stools

Stop Use & Ask a Doctor

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

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Questions

Questions or comments? 1-800-FDA-1088 Manufactured & Distributed by: Sunrise Pharmaceutical, Inc. Rahway, NJ 07065


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