Polyethylene Glycol 3350, NF Powder for Solution, Laxative POLYETHYLENE GLYCOL 3350 NF FOR LAXATIVE LGM PHARMA SOLUTIONS, LLC FDA Approved Use relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days
FunFoxMeds box
Route
ORAL
Applications
ANDA090812

Drug Facts

Composition & Profile

Active Ingredients
Active I ngredient (in each dose) Polyethylene Glycol 3350 17 g (cap filled to line)
Inactive Ingredients
Inactive ingredients none
Strengths
17 g
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 LGM PHARMA SOLUTIONS, LLC PRODUCT: Polyethylene Glycol 3350, NF Powder for Solution, Osmotic Laxative Relives Occasional Constipation/ I rregularity Softens Stool Unflavored Powder Sugar Free Net Wt. 4.1 OZ ( 119 g) 7 ONCE-DAILY DOSES NDC: 79739-7116- 1 LGM PHARMA SOLUTIONS, LLC PRODUCT: Polyethylene Glycol 3350, NF Powder for Solution, Osmotic Laxative o Relives Occasional Constipation/irregularity o Softens Stool o Unflavored Powder o Sugar Free Net Wt. 4.1 OZ (119g) 7 ONCE-DAILY DOSES NDC: 79739-7116-1; Principal Display Panel LGM PHARMA SOLUTIONS, LLC PRODUCT: Polyethylene Glycol 3350, NF Powder for Solution, Osmotic Laxative Reli e ves Occasional Constipation/ I rregularity Softens Stool Unflavored Powder Sugar Free NDC: 79739-7116-2 Net Wt. 8.3 OZ ( 238 g) 14 ONCE-DAILY DOSES LGM PHARMA SOLUTIONS, LLC PRODUCT: Polyethylene Glycol 3350, NF Powder for Solution, Osmotic Laxative o Relives Occasional Constipation/irregularity o Softens Stool o Unflavored Powder o Sugar Free NDC: 79739-7116-2 Net Wt. 8.3 OZ (238g) 14 ONCE-DAILY DOSES; Principal Display Panel LGM PHARMA SOLUTIONS, LLC PRODUCT: Polyethylene Glycol 3350, NF Powder for Solution, Osmotic Laxative Relives Occasional Constipation/ I rregularity Softens Stool Unflavored Powder Sugar Free NDC: 79739-7116-3 Net Wt. 17.9 OZ (510g) 30 ONCE-DAILY DOSES LGM PHARMA SOLUTIONS, LLC PRODUCT: Polyethylene Glycol 3350, NF Powder for Solution, Osmotic Laxative o Relives Occasional Constipation/irregularity o Softens Stool o Unflavored Powder o Sugar Free NDC: 79739-7116-3 Net Wt. 17.9 OZ (510g) 30 ONCE-DAILY DOSES

Package Descriptions
  • Principal Display Panel LGM PHARMA SOLUTIONS, LLC PRODUCT: Polyethylene Glycol 3350, NF Powder for Solution, Osmotic Laxative Relives Occasional Constipation/ I rregularity Softens Stool Unflavored Powder Sugar Free Net Wt. 4.1 OZ ( 119 g) 7 ONCE-DAILY DOSES NDC: 79739-7116- 1 LGM PHARMA SOLUTIONS, LLC PRODUCT: Polyethylene Glycol 3350, NF Powder for Solution, Osmotic Laxative o Relives Occasional Constipation/irregularity o Softens Stool o Unflavored Powder o Sugar Free Net Wt. 4.1 OZ (119g) 7 ONCE-DAILY DOSES NDC: 79739-7116-1
  • Principal Display Panel LGM PHARMA SOLUTIONS, LLC PRODUCT: Polyethylene Glycol 3350, NF Powder for Solution, Osmotic Laxative Reli e ves Occasional Constipation/ I rregularity Softens Stool Unflavored Powder Sugar Free NDC: 79739-7116-2 Net Wt. 8.3 OZ ( 238 g) 14 ONCE-DAILY DOSES LGM PHARMA SOLUTIONS, LLC PRODUCT: Polyethylene Glycol 3350, NF Powder for Solution, Osmotic Laxative o Relives Occasional Constipation/irregularity o Softens Stool o Unflavored Powder o Sugar Free NDC: 79739-7116-2 Net Wt. 8.3 OZ (238g) 14 ONCE-DAILY DOSES
  • Principal Display Panel LGM PHARMA SOLUTIONS, LLC PRODUCT: Polyethylene Glycol 3350, NF Powder for Solution, Osmotic Laxative Relives Occasional Constipation/ I rregularity Softens Stool Unflavored Powder Sugar Free NDC: 79739-7116-3 Net Wt. 17.9 OZ (510g) 30 ONCE-DAILY DOSES LGM PHARMA SOLUTIONS, LLC PRODUCT: Polyethylene Glycol 3350, NF Powder for Solution, Osmotic Laxative o Relives Occasional Constipation/irregularity o Softens Stool o Unflavored Powder o Sugar Free NDC: 79739-7116-3 Net Wt. 17.9 OZ (510g) 30 ONCE-DAILY DOSES

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 d o 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: use once a day fill to the top of white section in cap which is marked to indicate the correct dose (17g) stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink do not combine with starch-based thickeners used for difficulty swallowing ensure that the powder is fully dissolved before drinking do not drink if there are any clumps do not use 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 Manufactured by: LGM Pharma Solutions, LLC Irvine, CA 92614 7116-0 119 -99- EC -PD Rev. 01/2022 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.
Purpose

Purpose Osmotic Laxative

Do Not Use

Do not use if you have kidney disease, except under the advice and supervision of a doctor Manufactured by: LGM Pharma Solutions, LLC Irvine, CA 92614 7116-0 119 -99- EC -PD Rev. 01/2022

When Using

When using this product you may have 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 c omments? 1-877-288-1495 Polyethylene Glycol 3350, NF increases frequency of bowel movements and softens the stool.


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