Drug Facts

Active ingredient (in each dose)

Polyethylene Glycol 3350, 17 grams (cup filled to the indicated "17 GRAMS" 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.

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
this product is supplied with a dosing cup marked to contain 17 grams of powder when filled to the indicated line.
adults and children 17 years of age and older:
- fill to the indicated "17 GRAMS" line on cup which is marked to indicate the correct dose 17 grams
- stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
- Ensure that the powder is fully dissolved before drinking.
- Do not drink if there are any clumps.
- use once a day
- use no more than 7 days
children 16 years of age or younger: ask a doctor

Other information

store at 20° - 25°C (68° - 77°F)
tamper-evident: do not use if seal under cap printed with "SEALED for YOUR PROTECTION" is missing, open or broken.

Inactive ingredients

none

Questions or Comments?

call: 1-800-367-3395

Manufactured by:
LGM Pharma Solutions, LLC
Irvine, CA 92614

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

PRINCIPAL DISPLAY PANEL - 510 g Bottle Label

Polyethylene Glycol

3350 NF

Powder For Solution,
Osmotic Laxative

Relieves Occasional
Constipation/ Irregularity
Softens stool

POLYETHYLENE GLYCOL 3350
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17856-0962(NDC:51991-962)
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 17 g

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17856-0962-1	72 in 1 BOX, UNIT-DOSE	02/17/2021
1		4 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC:17856-0962-2	72 in 1 BOX, UNIT-DOSE	02/17/2021
2		4.25 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC:17856-0962-3	50 in 1 BOX, UNIT-DOSE	02/17/2021
3		8.50 g in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
4	NDC:17856-0962-4	72 in 1 BOX, UNIT-DOSE	02/17/2021
4		8.50 g in 1 POUCH; Type 0: Not a Combination Product
5	NDC:17856-0962-5	50 in 1 BOX, UNIT-DOSE	06/08/2021
5		4.25 g in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090812	03/27/2019

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Name	Address	ID/FEI	Business Operations
Establishment
ATLANTIC BIOLOGICALS CORP.		047437707	relabel(17856-0962) , repack(17856-0962)

Polyethylene Glycol 3350, NF Powder for Oral Solution