Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 4d524ace-9de5-4f62-9263-7cd88a36b67c
Route
ORAL
Published
Effective Date 2025-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol 3350 (17 g)

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2019-04-15

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

© 2023 & Distributed by

American Health Packaging

Columbus, Ohio 43217 USA

All rights reserved.

Overbagged with 7 x 0.6 OZ (17 g) packets in each bag, NDC 55154-8184-5

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Distributed By:

Cardinal Health

Dublin, OH 43017

L5568654-10124 / L5568654-20124

1047662/1047664/1049041/1046550

Principal Display Panel

NDC 55154-8184-5

HEALTHYLAX®

POLYETHYLENE GLYCOL 3350 NF

Powder for Oral Laxative Solution

7 SACHETS 0.6 OZ (17g) EACH

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

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

© 2023 & Distributed by

American Health Packaging

Columbus, Ohio 43217 USA

All rights reserved.

Overbagged with 7 x 0.6 OZ (17 g) packets in each bag, NDC 55154-8184-5

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Distributed By:

Cardinal Health

Dublin, OH 43017

L5568654-10124 / L5568654-20124

1047662/1047664/1049041/1046550

Principal Display Panel

NDC 55154-8184-5

HEALTHYLAX®

POLYETHYLENE GLYCOL 3350 NF

Powder for Oral Laxative Solution

7 SACHETS 0.6 OZ (17g) EACH

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

Advanced Ingredient Data


Raw Label Data

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