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

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

Relieves Occasional Constipation/Irregularity
Softens Stool
Unflavored Powder
Sugar Free

NDC: 79739-7116-2

Net Wt. 8.3 OZ (238g)

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/Irregularity
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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090812	10/07/2009

Labeler - LGM PHARMA SOLUTIONS, LLC (117549198)

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

PEG 3350

Active Ingredient (in each dose)

Purpose

Use

Warnings

Do not use

Ask a doctor before use if you have:

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if:

If pregnant or breast-feeding,

Keep out of reach of children.

Directions

Other Information

Inactive ingredients

Questions or comments?

Principal Display Panel

Principal Display Panel

Principal Display Panel