POLYETHYLENE GLYCOL 3350 powder, for solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (polyethylene glycol 3350 - UNII:G2M7P15E5P)
Available from:
Breeckenridge Pharmaceutical, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Osmotic Laxative - relieves occasional constipation (irregularity) - generally produces a bowel movement in 1 to 3 days
Authorization status:
Abbreviated New Drug Application
Authorization number:
51991-961-58, 51991-962-57

POLYETHYLENE GLYCOL 3350- polyethylene glycol 3350 powder, for solution

Breeckenridge Pharmaceutical, Inc.

----------

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)

Purpos e

Osmotic Laxative

Us e

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

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:

Nexgen Pharma, Inc.

Irvine, CA 92606

Distributed by:

Breckenridge Pharmaceutical, Inc.

Berlin, CT 06037

PRINCIPAL DISPLAY PANEL - 238 g Bottle Label

NDC 51991-961-58

Polyethylene Glycol

3350 NF

Powder for

Solution, Osmotic Laxative

Relieves Occasional

Constipation / Irregularity

Softens stool

NET WT. 8.3 OZ (238 g)

14 ONCE - DAILY DOSES

Breckenridge

Pharmaceutical, Inc.

PRINCIPAL DISPLAY PANEL - 510 g Bottle Label

NDC 51991-962-57

Polyethylene Glycol

3350 NF

Powder For Solution,

Osmotic Laxative

Relieves Occasional

Constipation/ Irregularity

Softens stool

NET WT 17.9 OZ (510 g)

30 ONCE - DAILY DOSES

Breckenridge

Pharmaceutical, Inc.

POLYETHYLENE GLYCOL 3350

polyethylene glycol 3350 powder, for solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:519 9 1-9 6 1

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO LYETHYLENE GLYCO L 3 3 50 (UNII: G2M7P15E5P) (po lyethylene glyco l 3350 -

UNII:G2M7P15E5P)

POLYETHYLENE GLYCOL

3350

17 g

in 17 g

Product Characteristics

Color

WHITE

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:519 9 1-9 6 1-58

238 g in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/27/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 9 0 8 12

0 3/27/20 19

POLYETHYLENE GLYCOL 3350

polyethylene glycol 3350 powder, for solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:519 9 1-9 6 2

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PO LYETHYLENE GLYCO L 3 3 50 (UNII: G2M7P15E5P) (po lyethylene glyco l 3350 -

UNII:G2M7P15E5P)

POLYETHYLENE GLYCOL

3350

17 g

in 17 g

Breeckenridge Pharmaceutical, Inc.

Product Characteristics

Color

WHITE

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:519 9 1-9 6 2-57

510 g in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/27/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 9 0 8 12

0 3/27/20 19

Labeler -

Breeckenridge Pharmaceutical, Inc. (150554335)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Nexgen Pharma, Inc.

16 0 356 114

MANUFACTURE(519 9 1-9 6 1, 519 9 1-9 6 2)

Revised: 11/2019

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