Polyethylene Glycol 3350, NF Powder for Oral Solution

Polyethylene Glycol 3350 by

Drug Labeling and Warnings

Polyethylene Glycol 3350 by is a Otc medication manufactured, distributed, or labeled by ATLANTIC BIOLOGICALS CORP.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

POLYETHYLENE GLYCOL 3350- polyethylene glycol 3350 powder, for solution 
ATLANTIC BIOLOGICALS CORP.

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Polyethylene Glycol 3350, NF Powder for Oral Solution

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

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POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 17856-0962(NDC: 51991-962)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (polyethylene glycol 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 335017 g  in 17 g
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 17856-0962-172 in 1 BOX, UNIT-DOSE06/04/2024
14 g in 1 POUCH; Type 0: Not a Combination Product
2NDC: 17856-0962-272 in 1 BOX, UNIT-DOSE06/04/2024
24.25 g in 1 POUCH; Type 0: Not a Combination Product
3NDC: 17856-0962-350 in 1 BOX, UNIT-DOSE06/04/2024
38.50 g in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
4NDC: 17856-0962-472 in 1 BOX, UNIT-DOSE06/04/2024
48.50 g in 1 POUCH; Type 0: Not a Combination Product
5NDC: 17856-0962-550 in 1 BOX, UNIT-DOSE06/04/2024
54.25 g in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09081203/27/201909/30/2024
Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
NameAddressID/FEIBusiness Operations
ATLANTIC BIOLOGICALS CORP.047437707repack(17856-0962)

Revised: 6/2024
Document Id: b7c44b51-e393-4a5a-820b-756b08798400
Set id: 4ef870f7-2f9f-4170-bc8d-6e9c52884c20
Version: 3
Effective Time: 20240604