Polyethylene Glycol 3350 — v107

Polyethylene Glycol 3350

9 Views

Version

v107

Effective date

September 30, 2025

Original packager

—

Sections captured

18

Identifiers

Document ID
3286920b-41aa-4157-8f16-ab3aeb9dd5b9
Set ID
5df518fb-ad58-4f17-af34-f66066f1313a
Application numbers
ANDA090685
Product NDCs
72162-2172
Package NDCs
72162-2172-2, 72162-2172-4
Original packager NDCs
45802-868

Names & Manufacturers

Brand names
Polyethylene Glycol 3350
Generic names
POLYETHYLENE GLYCOL 3350
Manufacturer names
Bryant Ranch Prepack
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
POLYETHYLENE GLYCOL 3350
Routes
ORAL
Pharmacologic class (PE)
Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
Pharmacologic class (EPC)
Osmotic Laxative [EPC]
Pharmacologic class (CS)
—
Mechanism of action
Osmotic Activity [MoA]

Other identifiers

NUI
N0000009871, N0000010288, N0000175811
RxCUI
—
UNII
G2M7P15E5P
UPC
—

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient (in each dose) Polyethylene Glycol 3350, 17 g (cap filled to line)
Ask Doctor (1)

Sequence 1

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 Doctor Or Pharmacist (1)

Sequence 1

Ask a doctor or pharmacist before use if you are taking a prescription drug
Do Not Use (1)

Sequence 1

Do not use if you have kidney disease, except under the advice and supervision of a doctor
Dosage And Administration (1)

Sequence 1

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 top of white section in cap which is marked to indicate the correct dose (17 g) • 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
How Supplied (1)

Sequence 1

HOW SUPPLIED Polyethylene Glycol 3350 17g of white powder when filled to the indicated line (white section in cap). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep Tightly Closed Dispense in a tight, light-resistant container as defined in the USP. NDC: 72162-2172-2: 238 g Powder for Solution NDC: 72162-2172-4: 510 g Powder for Solution Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Inactive Ingredient (1)

Sequence 1

Inactive ingredients none
Indications And Usage (1)

Sequence 1

Use • relieves occasional constipation (irregularity) • generally produces a bowel movement in 1 to 3 days
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Package Label Principal Display Panel (1)

Sequence 1

Polyethylene Glycol 3350 Powder #238 Label
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast-feeding, ask a health professional before use.
Purpose (1)

Sequence 1

Purpose Osmotic Laxative
Questions (1)

Sequence 1

Questions or comments? 1-800-719-9260
Spl Product Data Elements (1)

Sequence 1

Polyethylene Glycol 3350 Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350
Stop Use (1)

Sequence 1

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
Storage And Handling (1)

Sequence 1

Other information • store at 20°-25°C (68°-77°F) • tamper-evident: do not use if printed foil seal under cap is missing, open or broken
Warnings (1)

Sequence 1

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 (1-800-222-1222).
When Using (1)

Sequence 1

When using this product you may have loose, watery, more frequent stools

OpenFDA raw payload

{'application_number': ['ANDA090685'],
 'brand_name': ['Polyethylene Glycol 3350'],
 'generic_name': ['POLYETHYLENE GLYCOL 3350'],
 'manufacturer_name': ['Bryant Ranch Prepack'],
 'nui': ['N0000010288', 'N0000175811', 'N0000009871'],
 'original_packager_product_ndc': ['45802-868'],
 'package_ndc': ['72162-2172-2', '72162-2172-4'],
 'pharm_class_epc': ['Osmotic Laxative [EPC]'],
 'pharm_class_moa': ['Osmotic Activity [MoA]'],
 'pharm_class_pe': ['Stimulation Large Intestine Fluid/Electrolyte Secretion '
                    '[PE]'],
 'product_ndc': ['72162-2172'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'spl_id': ['3286920b-41aa-4157-8f16-ab3aeb9dd5b9'],
 'spl_set_id': ['5df518fb-ad58-4f17-af34-f66066f1313a'],
 'substance_name': ['POLYETHYLENE GLYCOL 3350'],
 'unii': ['G2M7P15E5P']}