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:
American Health Packaging
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Laxative - relieves occasional constipation (irregularity) - generally produces a bowel movement in 1 to 3 days
Authorization status:
Abbreviated New Drug Application
Authorization number:
60687-431-92, 60687-431-98, 60687-431-99

POLYETHYLENE GLYCOL 3350- polyethylene glycol 3350 powder, for solution

American Health Packaging

----------

Drug Facts

Polyethylene Glycol 3350, Powder for Oral Solution

Active Ingredient (in each sachet)

Polyethylene Glycol 3350, NF 17g

Purpos e

Laxative

Us es

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 of 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 the 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

adults and children 17 years of age and older:

stir and dissolve one sachet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room

temperature)

drink the solution.

use once a day

use no more than 7 days

children 16 years of age or under: ask a doctor

Other Information

store at 20° - 25°C (68° - 77°F)

do not use if foil is open or broken.

Inactive Ingredients

none

Questions or comments?

1-800-707-4621 or www.americanhealthpackaging.com

© 2019 & Distributed by

American Health Packaging

Columbus, Ohio 43217 USA

All rights reserved.

1037831/1037832

Package/Label Display Panel - Carton - 17 g - 14UD

NDC 60687- 431-98

healthylax

POLYETHYLENE GLYCOL 3350 NF

Powder for Oral Laxative Solution

14 SACHETS

Net Wt. 0.6 OZ (17g) EACH

Distributed by American Health Packaging, Columbus, Ohio 43217

PACKAGE/LABEL DISPLAY PANEL - CARTON - 17 G - 100 UD

®

NDC 60687- 431-92

healthylax

P OLYETHYLENE GLYCOL 3350 NF

Powder for Oral Laxative Solution

100 - 17 g SACHETS

Net Wt. 0.6 OZ (1700g)

Distributed by American Health Packaging, Columbus, Ohio 43217

Package/Label Display Panel – Sachet – 17 g

®

NDC 60687- 431-99

healthylax

POLYETHYLENE GLYCOL 3350 NF

Powder for Oral Laxative Solution

Net Wt. 0.6 OZ (17g)

Distributed by American Health Packaging, Columbus, Ohio 43217

POLYETHYLENE GLYCOL 3350

polyethylene glycol 3350 powder, for solution

®

American Health Packaging

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 0 6 8 7-431

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) (POLYETHYLENE GLYCOL 3350 -

UNII:G2M7P15E5P)

POLYETHYLENE GLYCOL

3350

17 g

in 17 g

Inactive Ingredients

Ingredient Name

Stre ng th

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

white (Co lo rless upo n disso lutio n)

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:6 0 6 8 7-431-9 8

14 in 1 CARTON

0 4/15/20 19

1

NDC:6 0 6 8 7-431-9 9

17 g in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:6 0 6 8 7-431-9 2

10 0 in 1 CARTON

0 1/31/20 20

2

NDC:6 0 6 8 7-431-9 9

17 g in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 39 28

0 4/15/20 19

Labeler -

American Health Packaging (929561009)

Revised: 1/2020

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