POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE powder, for solution

Polyethylene Glycol 3350, NF Powder for Solution, Laxative by

Drug Labeling and Warnings

Polyethylene Glycol 3350, NF Powder for Solution, Laxative by is a Otc medication manufactured, distributed, or labeled by LGM PHARMA SOLUTIONS, LLC, LGM Pharma Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient (in each dose)

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

Purpose

Osmotic Laxative

Use

• 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

Manufactured by:

LGM Pharma Solutions, LLC

Irvine, CA 92614

7116-0119-99-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.

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 (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

Other Information

• store at 20° – 25°C (68° – 77°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? 

1-877-288-1495

Polyethylene Glycol 3350, NF increases frequency of bowel movements and softens the stool.

Principal Display Panel

LGM PHARMA SOLUTIONS, LLC

PRODUCT: Polyethylene Glycol 3350, NF Powder for Solution, Osmotic Laxative

• Relives Occasional Constipation/Irregularity
  
• Softens Stool
  
• Unflavored Powder
  
• 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

• Relieves Occasional Constipation/Irregularity
  
• Softens Stool
  
• Unflavored Powder
  
• 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/Irregularity
  
• Softens Stool
  
• Unflavored Powder
  
• Sugar Free

NDC: 79739-7116-3

Net Wt. 17.9 OZ (510g)

30 ONCE-DAILY DOSES

INGREDIENTS AND APPEARANCE

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	Item Code (Source)	NDC: 79739-7116
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P)	POLYETHYLENE GLYCOL 3350	17 g  in 1 d

Product Characteristics
Color	white (colorless upon dissolution)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79739-7116-1	7 d in 1 BOTTLE; Type 0: Not a Combination Product	10/07/2009
2	NDC: 79739-7116-2	14 d in 1 BOTTLE; Type 0: Not a Combination Product	10/07/2009
3	NDC: 79739-7116-3	30 d in 1 BOTTLE; Type 0: Not a Combination Product	10/07/2009

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

Labeler - LGM PHARMA SOLUTIONS, LLC (117549198)

Establishment
Name	Address	ID/FEI	Business Operations
LGM Pharma Solutions, LLC		117549200	analysis(79739-7116) , label(79739-7116) , manufacture(79739-7116) , pack(79739-7116)