FDA.reportPublic FDA data

healthylax

Manufacturer
American Health Packaging
Effective date
2019-05-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:23:17

Label at a glance#

Producthealthylax
Active ingredientPOLYETHYLENE GLYCOL 3350
Label structure11 sections

Dosage and administration

Do not take more than directed unless advised by your doctor Stir and dissolve one packet of powder (17 g) in a glass (4 to 8 oz.) of water, juice, soda, coffee, or tea until completely dissolved. Drink the solution. Daily dose is 17 grams per day or as directed by a healthcare professional. Treatment for 2 to 4 days may be required to produce a bowel movement. Use for 2 weeks or less. Should not be used by children.

Storage and handling

Store at 20°-25°C (68°-77°F); excursions permitted to 15º - 30ºC (59º - 86ºF). [See USP Controlled Room Temperature] Tamper-evident: do not use if foil is open or broken.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each dose)

OTC - ACTIVE INGREDIENT SECTION

Polyethylene Glycol 3350 NF - 17 g

Purpose

OTC - PURPOSE SECTION

Laxative

Use

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 2 to 4 days

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

Do not use if you are allergic to polyethylene glycol

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have:

  • nausea, vomiting, abdominal pain or distention.
  • suspected bowel syndrome

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug

OTC - WHEN USING SECTION

When using this product you may have loose, watery, more frequent stools

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • you have unusual cramps, bloating or diarrhea.
  • you get hives or skin rashes.
  • you need to use a laxative for longer than 2 weeks.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Do not take more than directed unless advised by your doctor
  • Stir and dissolve one packet of powder (17 g) in a glass (4 to 8 oz.) of water, juice, soda, coffee, or tea until completely dissolved.
  • Drink the solution.
  • Daily dose is 17 grams per day or as directed by a healthcare professional.
  • Treatment for 2 to 4 days may be required to produce a bowel movement.
  • Use for 2 weeks or less.
  • Should not be used by children.

Other information

STORAGE AND HANDLING SECTION

  • Store at 20°-25°C (68°-77°F); excursions permitted to 15º - 30ºC (59º - 86ºF). [See USP Controlled Room Temperature]
  • Tamper-evident: do not use if foil is open or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

none

PRINCIPAL DISPLAY PANEL - 17g Packet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Healthylax CartonHealthylax Carton

NDC 68084-430-98

healthylax
Polyethylene Glycol 3350 NF,
Powder for Oral Laxative Solution

  • Relieves Occasional Constipation
  • Softens Stool
  • 14 Daily Doses

NET WT. 14 - 17 g SACHETS
8.4 Oz. (238g)

Healthylax Pouch - 17 g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Healthylax Pouch 17 gHealthylax Pouch 17 g

NDC 68084-430-99

healthylax
POLYETHYLENE GLYCOL 3350 NF

Powder for Oral Laxative Solution

  • Relieves Occasional Constipation
  • Softens Stool
  • 1 Daily Dose

NET WT. 17g

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-430-98EA - Each68084-4302913a5fd-51cb-4c85-a6ee-36a1caa2330212012-07-24
68084-430-99EA - Each68084-4303c718bdf-8e0d-4132-bf07-687e210442e112012-07-24
0722-7116-01GM - Gram0722-7116473bc880-16df-4d3b-a436-1b55a5f6f9da12012-07-24
0722-7116-02GM - Gram0722-7116597d615e-874a-429e-956c-cbfd90d0e20812012-07-24
0722-7116-03GM - Gram0722-7116bb77f060-d264-454f-a02b-58e8a83a882b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5P2
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5P2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68084-43068084-430-99, 68084-430-98
0722-7116

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 3350G2M7P15E5PACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090812-001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0784e616aacf4f…
2026-08-18 06:07:402026-07A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-073f01610625f2…
2019-09-15 20:21 UTC2019-09A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8a19d497-6e29-1f69-e053-2a95a90a0fd09b14e26f-17cb-4890-bb47-9db79f352bd22019-05-30WarningsExact identifier
spl id: 8a19d497-6e29-1f69-e053-2a95a90a0fd0
spl set id: 9b14e26f-17cb-4890-bb47-9db79f352bd2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.