POLYETHYLENE GLYCOL 3350 powder, for solution

POLYETHYLENE GLYCOL 3350 by

Drug Labeling and Warnings

POLYETHYLENE GLYCOL 3350 by is a Prescription medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each dose)

Polyethylene Glycol 3350, 17 grams (cap filled to the top)

Purpose

Osmotic Laxative

Uses

• 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
• the bottle top is a measuring cup marked to contain 17 grams of powder when filled to the indicated “17 GRAMS” line
• adults and children 17 years of age and older:
• use once a day
• fill to indicated “17 GRAMS” line in cap 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
• 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?

1-800-540-3765

HOW SUPPLIED

NDC: 72162-2180-2: 238 g in a BOTTLE

NDC: 72162-2180-4: 510 g in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

PRINCIPAL DISPLAY PANEL

Polyethylene Glycol 3350 Powder

INGREDIENTS AND APPEARANCE

POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72162-2180(NDC:57896-489)
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 17 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72162-2180-2	238 g in 1 BOTTLE; Type 0: Not a Combination Product	02/02/2024
2	NDC: 72162-2180-4	510 g in 1 BOTTLE; Type 0: Not a Combination Product	02/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090812	05/01/2014

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(72162-2180) , RELABEL(72162-2180)