POLYETHYLENE GLYCOL 3350 powder, for solution

Polyethylene Glycol 3350 by

Drug Labeling and Warnings

Polyethylene Glycol 3350 by is a Otc medication manufactured, distributed, or labeled by American Health Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each sachet)

Polyethylene Glycol 3350, NF 17g

Purpose

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 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

INGREDIENTS AND APPEARANCE

POLYETHYLENE GLYCOL 3350 
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60687-431
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

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (Colorless upon dissolution)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60687-431-98	14 in 1 CARTON	04/15/2019
1	NDC: 60687-431-99	17 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 60687-431-92	100 in 1 CARTON	01/31/2020
2	NDC: 60687-431-99	17 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA203928	04/15/2019

Labeler - American Health Packaging (929561009)