Drug Facts

Drug Facts

SPL v6

SPL

SPL Set ID 81374641-e54c-4b41-a3ad-49b19a097666

Route

ORAL

Published

Effective Date 2019-04-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Polyethylene Glycol 3350 (17 g)

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

ANDA Active Since 2019-05-29

Description

Polyethylene Glycol 3350, NF 17g

Purpose

Laxative

Medication Information

Purpose

Laxative

Description

Polyethylene Glycol 3350, NF 17g

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

Directions

do not take more than directed unless advised by your doctor
adults and children 17 years of age and older:
use once a day
stir and dissolve one sachet of powder (17 g) 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)
do not use if foil is open or broken.

Inactive Ingredients

none

Questions Or Comments?

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

1047662/1047664/1049041/1046550

When Using This Product

you may have loose, watery, more frequent stools

Ask A Doctor of Pharmacist

before use if you are taking a prescription drug

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.

Active Ingredient (in Each Sachet)

Polyethylene Glycol 3350, NF 17g

Keep Out of the Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

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

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

Package/label Display Panel Carton 17 G 30ud

NDC 60687- 431-27

healthylax ^®

POLYETHYLENE GLYCOL 3350 NF

Powder for Oral Laxative Solution

30 SACHETS

Net Wt. 18 OZ (510g)

Distributed by American Health Packaging, Columbus, Ohio 43217

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 100ud

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

Structured Label Content

Uses

relieves occasional constipation (irregularity)
generally produces a bowel movement in 1 to 3 days

Purpose

Laxative

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

Directions

do not take more than directed unless advised by your doctor
adults and children 17 years of age and older:
use once a day
stir and dissolve one sachet of powder (17 g) 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)
do not use if foil is open or broken.

Inactive Ingredients

none

Questions Or Comments? (Questions or comments?)

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

1047662/1047664/1049041/1046550

When Using This Product (When using this product)

you may have loose, watery, more frequent stools

Ask A Doctor of Pharmacist (Ask a doctor of pharmacist)

before use if you are taking a prescription drug

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredient (in Each Sachet) (Active Ingredient (in each sachet))

Polyethylene Glycol 3350, NF 17g

Keep Out of the Reach of Children. (Keep out of the reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (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

Package/label Display Panel – Sachet – 17 G (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

Package/label Display Panel Carton 17 G 30ud (PACKAGE/LABEL DISPLAY PANEL - CARTON - 17 G - 30UD)

NDC 60687- 431-27

healthylax ^®

POLYETHYLENE GLYCOL 3350 NF

Powder for Oral Laxative Solution

30 SACHETS

Net Wt. 18 OZ (510g)

Distributed by American Health Packaging, Columbus, Ohio 43217

Package/label Display Panel Carton 17 G 14ud (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 100ud (Package/Label Display Panel - Carton - 17 g - 100UD)

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

Advanced Ingredient Data

[{"name": "POLYETHYLENE GLYCOL 3350", "unii": "G2M7P15E5P", "classCode": "ACTIB", "strengthNumerator": "17", "strengthDenominator": "17", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days", "Purpose": "Laxative", "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", "Directions": "do not take more than directed unless advised by your doctor adults and children 17 years of age and older: use once a day stir and dissolve one sachet of powder (17 g) 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) do not use if foil is open or broken.", "Inactive Ingredients": "none", "Questions or comments?": "1-800-707-4621 or www.americanhealthpackaging.com © 2023 & Distributed by American Health Packaging Columbus, Ohio 43217 USA All rights reserved. 1047662/1047664/1049041/1046550", "When using this product": "you may have loose, watery, more frequent stools", "Ask a doctor of pharmacist": "before use if you are taking a prescription drug", "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.", "Active Ingredient (in each sachet)": "Polyethylene Glycol 3350, NF 17g", "Keep out of the reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away.", "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", "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", "PACKAGE/LABEL DISPLAY PANEL - CARTON - 17 G - 30UD": "NDC 60687- 431 -27 healthylax ® POLYETHYLENE GLYCOL 3350 NF Powder for Oral Laxative Solution 30 SACHETS Net Wt. 18 OZ (510g) Distributed by American Health Packaging, Columbus, Ohio 43217", "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 - 100UD": "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:33.056031 · Updated: 2026-03-14T23:13:48.939099